NuGen Surgical, Inc. received 510(k) clearance from the U.S. FDA to market a new technology cervical plate design with a unique patented double locking mechanism. This new easy to use patented locking mechanism provides the surgeon with both visual, audible and tactile confirmation of the cervical screw being locked.

NuGen Surgical Inc. announces the 510(k) U.S. FDA clearance of the Cavetto Cervical Cage IBF System. Cavetto Cages are designed to optimize endplate contact and resist subsidence. Made from radiolucent PEEK material enhancing visualization of the fusion process and with intuitive, ergonomic surgeon friendly instrumentation. Cavetto cages incorporate tantalum markers for clear intra-operative placement and visualization.

NuGen Surgical, Inc. received 510(k) clearance from the U.S. FDA to market a new technology MIS approach, cannulated facet screw system. The over-the-wire approach allows for additional tissue preservation and reduced hardware requirements. The Resolute screws are designed with a unique low-profile no-washer design minimizing soft tissue disruption and preserves adjacent level anatomy.

In June 2014, NuGen Surgical Inc., was audited by the United States Food and Drug Administration (FDA). The FDA audit confirms that the quality system implemented by NuGen Surgical, Inc. is in full compliance with GMP (current Good Manufacturing Practices) regulations. This outcome proves the conformity of our company to the standards indicated by the FDA.

NuGen Surgical, Inc. received 510(k) clearance from the U.S. FDA to market the Transom Anterior Cervical Plate System. This new technology cervical plate system incorporates more of NuGen Surgical, Inc. patented technologies allowing for a one-step locking mechanism with visual and tactile lock verification.

NuGen Surgical, Inc. announces that they have concluded a manufacturing and distribution agreement with Stryker Spine (Allendale, N.J.) for the Tempus Anterior Cervical Plating System. NuGen Surgical, Inc. remains the manufacturer of record and Stryker owns the Tempus IP.

NuGen Surgical, Inc. announces that they have concluded a manufacturing and distribution agreement with Integra LifeSciences (SeaSpine) for the Transom Anterior Cervical Plating System. NuGen Surgical, Inc. remains the manufacturer of record and Integra Lifesciences (SeaSpine) owns the Transom IP.

NuGen Surgical, Inc. announces the 510(k) U.S. FDA clearance of the Arco-SA, Stand-Alone ALIF System. Arco-SA is a PEEK spacer supplied prepacked sterile with multiple footprints and lordotic angles to accommodate patient anatomy. Surgeon friendly ergonomically design instrumentation allows for easy insertion and positioning. Titanium plate with locking screws provides substantial stable fixation.

NuGen Surgical, Inc. received 510(k) clearance from the U.S. FDA to market the latest technology pedicle screw based spinal system and Minimally Invasive Spinal System – Palladian. Palladian Spinal Systems incorporate a large array of implants for both the Percutaneous and mini-open approaches. Double lead thread design reduces insertion time and friction screw head allows for easy rod insertion. All screws incorporate the Helical Flange technology which has been proven to minimize cross threading of set screws while allowing for the lowest of profile screw design. Multiple patents have been filed for the Palladian Screw technology.

We are pleased to announce that NuGen Surgical has won the prestigious Golden Mousetrap Awards 2017, for our Belvedere Lateral Plating System. The Golden Mousetrap Awards acknowledge the American people, companies, and technologies driving innovation in product design and manufacturing. Specifically, we celebrate the renaissance of manufacturing in North America by honoring the companies and people who make it possible while promoting engineering and manufacturing as rewarding career choices for our next generation of stars. The annual Golden Mousetrap Awards was on February 7th, 2017 in conjunction with the MD&W, ATX West, Electronics West, WestPack, Pacific Design & Manufacturing, and PLASTEC West shows in Anaheim, California. For more information on the Golden Mousetrap Awards please visit GoldenMousetraps.com.

NuGen Surgical today announced that their Belvedere Lateral Plating System has been selected as the a Winner in the 19th Annual Medical Design Excellence Awards competition. The 2017 winning products were announced at the MDEA Ceremony held Tuesday, June 13, 2017 in conjunction with the MD&M East event at the Jacob K. Javits Convention Center in New York. The MDEA’s are the medical technology industry’s premier design competition committed to searching for the world’s highest caliber finished medical devices, products, systems, or packaging available on the market. The awards program celebrates the achievements of the medical device manufacturers, their suppliers, and the many people behind the scenes—engineers, scientists, designers, and clinicians—who are responsible for the cutting-edge products that are saving lives; improving patient healthcare; and transforming medtech—one innovation at a time.

NuGen Surgical, Inc. announces the 510(k) U.S. FDA clearance of the Cortina Lumbar Cage System. The Cortina Lumbar Cage System comprises of Cortina cages designed to optimize endplate contact and resist subsidence along with intuitive, ergonomic surgeon-friendly instrumentation. The Cortina cages are made from radiolucent PEEK material enhancing visualization of the fusion process while incorporating tantalum markers for clear intra-operative placement.

NuGen Surgical, Inc. announces the 510(k) U.S. FDA clearance of the Cavetto-SA Stand Alone Cervical Cage System. The Cavetto-SA Stand Alone Cervical Cage System comprises of Cavetto–SA cages and Screws designed to optimize endplate contact and resist subsidence. The system uses a simple and unique One-Step locking mechanism to allow a Zero – Profile construct. Along with intuitive, ergonomic surgeon-friendly instrumentation Cavetto-SA provides a state of the art solution. The Cavetto cages are made from radiolucent PEEK material enhancing visualization of the fusion process while incorporating tantalum markers for clear intra-operative placement.

NuGen Surgical, Inc. announces the 510(k) U.S. FDA clearance of the Cavetto Cervical Cage System. The Cavetto Cervical Cage System comprises of Cavetto cages designed to optimize endplate contact and resist subsidence along with intuitive, ergonomic surgeon-friendly instrumentation. The Cavetto cages are made from radiolucent PEEK material enhancing visualization of the fusion process while incorporating tantalum markers for clear intra-operative placement.

NuGen Surgical, Inc. announces the 510(k) U.S. FDA clearance of the Arco-SA Lumbar Cage System. The Arco-SA Lumbar Cage System comprises of Arco-SA cages and screws designed to optimize endplate contact and resist subsidence. The system uses a simple and unique One-Step locking mechanism to allow a Zero – Profile construct. Along with intuitive, ergonomic surgeon-friendly instrumentation, Arco-SA provides a state of the art solution. The Arco-SA cages are made from radiolucent PEEK material enhancing visualization of the fusion process while incorporating tantalum markers for clear intra-operative placement.

NuGen Surgical, Inc. announces that they have concluded a manufacturing and distribution agreement with Centinel Spine for the Trifore Anterior Cervical Plating System. NuGen Surgical, Inc. remains the manufacturer of record and Centinel Spine owns the Trifore IP and will add it to their product portfolio under the name Fortos C.

NuGen Surgical, Inc. announces the 510(k) U.S. FDA clearance of the Arco-SA Ti Stand-Alone Titanium ALIF System. The Arco-SA Ti System comprises of Arco-SA Ti cages and screws designed to optimize endplate contact and resist subsidence. The system uses a simple and unique One-Step locking mechanism to allow a Zero – Profile construct. Along with intuitive, ergonomic surgeon-friendly instrumentation, Arco-SA Ti provides a state of the art solution. The Arco-SA Ti cages are made from porous Titanium to provide excellent long-term fixation with a trabecular structure for multi-axial new bone in-growth.

We are very pleased with our new collaboration with Pinnacle Spine. This new partnership accelerates NuGen Surgical long term strategy to enter the lateral access spine procedure market. NuGen Surgical can now immediately present a full complement of innovative and unique procedural solutions for the lateral access approach for spine surgery. This solution is now available for all our distributors, clinicians, and any potential new partners. With today’s announcement, NuGen Surgical can now offer a full set of innovative lateral access retractors, instruments, and interbody implants, as well as lateral plates. More specifically, this product offering is inclusive of angled instruments designed to address the more complex L4-5 procedures. Pinnacle Spine has been recognized for pioneering the novel design concept of placing bone graft material into an implanted device in situ, maximizing the graft material volume within the disc space. The InFill technology allows for complete, endplate-to-endplate contact – a critical element in positive fusion outcomes. This announcement is an exciting phase of innovation and growth for NuGen Surgical in 2019. We also have several key projects moving through the FDA, set to be released in Q4 of 2019. This integration of the Pinnacle Spine products into NuGen Surgical product offerings is an excellent fit and will be an impactful addition for our current and new distributors. All of the Pinnacle Spine products are currently available through NuGen Surgical emailing us at customerservice@neurostructures.com. NuGen Surgical is a medical device company focused on designing, developing, manufacturing, and marketing proprietary, high-quality medical device systems. All of our products provide comprehensive medical solutions to improve and enhance the quality of life for patients. NuGen Surgical is dedicated to exceeding expectations in product quality, customer service, and product cost. The company is led by a team of experienced marketing, engineering, and sales individuals with extensive knowledge and training in the domestic and international spine surgery device markets.

NuGen Surgical, Inc. announces that they have concluded a non-exclusive distribution agreement with PorOsteon Spine Inc. for the Cavetto Phusion Metal Cervical Cage System.

NuGen Surgical, Inc. announces the signing of an agreement with Stryker Spine as an approved Product Development/design contractor for Stryker Spine development projects.

NuGen Surgical, Inc. received 510(k) clearance from the U.S. FDA to market the latest technology pedicle screw based spinal system and Minimally Invasive Spinal System – Palladian. Palladian Spinal Systems incorporate a large array of implants for both the Percutaneous and mini-open approaches. Double lead thread design reduces insertion time and friction screw head allows for easy rod insertion. All screws incorporate the Helical Flange technology which has been proven to minimize cross threading of set screws while allowing for the lowest of profile screw design. Multiple patents have been filed for the Palladian Screw technology.

NuGen Surgical, Inc., is proud to announce it is now certified as ISO 13485 compliant. The certification is accredited by Lloyd’s Register Quality Assurance, Inc. (LRQA). To become certified as ISO 13485 compliant, NuGen Surgical, Inc. underwent a thorough evaluation process that included quality management system development, a management system documentation review, pre-audit, initial assessment, and clearance of non-conformances, all of which work to identify corrective actions that elimination non-conformance to the quality management standard. NuGen Surgical received its ISO 13485 certificate of registration on September 11, 2015. The certification of compliance with ISO 13485 recognizes that the policies, practices and procedures of our company ensure consistent quality in the services and work product we provide our customers. With this certification, our clients can be confident that NuGen Surgical is dedicated to maintaining the highest efficiency and responsiveness in achieving our ultimate goal – guaranteed customer satisfaction. To maintain our certification, LRQA will perform annual audits to ensure compliance and to assess initiatives for continued improvement. Our customers can be confident that NuGen Surgical will continue to provide the high quality services they have come to expect well into the future. We believe that our decision to become ISO 13485 Certified is a proactive one that not only anticipates the demands of our customers, but also demonstrates our commitment to providing quality services to all our customers in the medical industry.

NuGen Surgical, Inc. announces that they have concluded a manufacturing and distribution agreement with XTANT Medical for the Palladian Spinal Fixation System.

NuGen Surgical, Inc. received 510(k) clearance from the U.S. FDA to market the Belvedere Lateral Plating System. This new technology lateral plate system incorporates more of NuGen Surgical, Inc. patented technologies allowing for its expanding mechanism with tactile lock verification.

NuGen Surgical, Inc. announces that they have concluded a distribution agreement with Pinnacle Spine Group for the InFill System.

Inc. magazine ranked NuGen Surgical, Inc. number 64 on it’s 35th annual Inc. 5000, the most prestigious ranking of the nation’s fastest-growing private companies. The list represents a unique look at the most successful companies within the American economy’s most dynamic segment – it’s independent small businesses. About the Inc. 500|5000 The Inc. 500|5000 is a list of the fastest-growing private companies in the nation. Started in 1982, this prestigious list of the nation’s most successful private companies has become a hallmark of entrepreneurial success. The Inc. 500|5000 Conference & Awards Ceremony is an annual event that celebrates their remarkable achievements. The event also offers informative workshops, celebrated keynote speakers, and evening functions. For more information on Inc. and the Inc. 500|5000 Conference, www.inc.com.

NuGen Surgical, Inc. has been transferred the 510(k) clearance from PorOsteon Spine Inc. to market the Cavetto Phusion Metal Cervical Cage System. Phusion Metal is a proprietary and novel porous intermetallic compound that obtains an irregular open porous structure optimized for bone ingrowth with an elastic modulus within the range of human cancellous bone.

With direct product ordering form submission, the NuGen Surgical app is the perfect tool to help streamline the ordering process. The app has a complete order form for all of NuGen Surgical products.

NuGen Surgical, Inc. received 510(k) clearance from the U.S. FDA to market the Transept Cervical Plating System. This new technology cervical plate system incorporates more of NuGen Surgical, Inc. patented technologies with hyper-angulation on the superior/inferior ends, one-step locking mechanism with visual and tactile lock verification, and screw height variances.

Cavetto Phusion Metal

Phusion Metal is a proprietary and novel porous intermetallic compound that obtains an irregular open porous structure optimized for bone ingrowth. The elastic modulus of 0.7-1.3 GPa lies within the range of human cancellous bone. A low elastic modulus may preserve bone stock and reduce implant subsidence. Surface friction allows for initial stability and reduces the risk of implant migration. This unique and osteoconductive porous structure allows bone to grow throughout the irregular pores resulting in a more rapid and robust fusion.

A short-term bone ingrowth study was designed to evaluate Phusion Metal in an ovine model. Implants were evaluated for histological review at 2-week, 4-week, 6-week, 8-week and 12-week time points.

Eight sheep underwent an instrumented 2-level lumbar intervertebral fusion at L2-L3 and L4-L5. Each animal was implanted with two different types of interbody fusion cages: commercially approved PEEK cage with autologous bone graft; Phusion Metal cage with autologous bone graft. The animals were evenly divided into 2 time points on the basis of follow-up period; 4 months and 6 months.

The right and left tibias were isolated free of soft tissue and the surgical sites photographed using a digital camera. The surgical sites were examined for signs of adverse reaction or infection. The distant organs (heart, liver, lung, kidney, spleen, regional lymph nodes) were harvested, imaged and processed for routine histopathology. All samples were processed for gross observation. Bones were X-rayed in the anteroposterior and lateral views to determine implant placement as well as for any adverse bony reactions.

Cortical implants were placed in 10% buffered formalin and sequentially dehydrated in increasing concentrations of ethanol for embedding in polymethylmethacrylate (PMMA). Embedded cortical implants were sectioned for histological evaluation. Sections were stained with methylene blue and basic fuchsin for examination under a light microscope for bone organization within the porous implant and reaction at the implant-bone interface. Cortical histology was assessed as per ISO 10993-6 for local tissue reactions.

Both the protocol and qualifications of the personnel involved in the study were reviewed and approved by the Institutional Animal Care and Ethics Committee (ACEC).

Histology at 2 weeks demonstrated an intimate bone-implant interface between the implant and the bone. New bone formation integrating into the porous domains of the implant was noted. No adverse reactions were noted from a cellular point of view within the pores of the implant. No evidence of infection or any inflammatory cells was noted. New bone formed directly on the surface and into the pores at 2 weeks.

Histology at 4 weeks demonstrated an increase in new bone integration into the porous domains of the implant compared to the 2-week time point. No changes were observed in the features of the connective tissue within the center of the implant. No adverse reactions were noted at the 4-week time point.

Histology at 6 weeks demonstrated complete new bone integration into the porous domains of the implant. Complete bone ingrowth from one cortex to the other in the medial and lateral sites was noted as early as the 6-week time point. No adverse reactions were noted.

Histology at 8 weeks demonstrated new bone integration and remodeling within the porous domains of the implant. No intervening fibrous tissue was noted at the bone implant interface at the margins or within the center of the implant. Complete bone ingrowth from one cortex to the other in the medial and lateral sites was noted. Interestingly new bone was seen growing up the implant into the medullary canal.

Histology at 12 weeks demonstrated to continue progression and remodeling of the bone within the implant. No adverse reactions were noted at 12 weeks. As noted at 8 weeks, there were areas of bone formation into the medullary canal of the cortical implantation sites. This bone appeared to walk through the implant. This supports the overall all osteoconductive nature of the fully porous material implanted in the study.

Surgical implantation of Phusion Metal was achieved in all animals without any adverse events. The implants were implanted into their designated sites without any issues. The wounds were all well-healed and normal ambulation recovery was noted in all animals. There were no adverse reactions to the organs. Radiographic evaluation of the implantation size was uneventful with no evidence of fracture or implant related issues. Macroscopic evaluations did not reveal any adverse reactions to the implants across any group. No evidence of any adverse reactions was noted in the cortical histology at any time point.

New bone integration into the porous domains of the porous structure was noted as early as 2 weeks and continual progression of new bone formation into the porous domains of the implant improved with time. Complete bone ingrowth from one cortex to the other in the medial and lateral sites was noted as early as 6 weeks.

As noted at the 8 and 12 weeks, interestingly, new bone formation was seen growing up the implant into the medullary canal. All implants at 8 and 12 weeks demonstrated complete bone growth from on cortex to the other in the medial and lateral sites. Bone appeared to walk through and up the porous implant.

Phusion Metal has a unique and osteoconductive porous structure that allows bone to grow throughout the irregular pores resulting in a more rapid and robust fusion. The irregular pore size distribution and surface topography of the material is very friendly to the body and supported direct bone formation onto and throughout the implant.

This evidence supports biocompatibility, initial implant stability, short-term bone ingrowth and the osteoconductive nature of a proprietary and novel porous intermetallic compound used in an ovine study.

Refer to the Cavetto Phusion Metal Instructions for Use for proper use, precautions, warnings, indications, and labeling.

Fellowship Trained Board Certified Orthopaedic Spine Surgeon
Teton Orthopaedics
Jackson Hole, Wyoming

Herniated Cervical Discs Cervical 5 – 7 with Cervical Radiculopathy

Pre-Operative Diagnosis:

1. Cervical stenosis C5 – C7
2. Herniated nucleus pulposus C5 – C7
3. Cervical radiculopathy
4. Cervicogenic headaches
5. Axial neck pain

Patient is a 36 year old female who was diagnosed with continued severe neck pain with the bilateral upper extremity radiculopathy left greater than right. Treatment history included three years of physical therapy.

Cervical mobility is inhibited secondary to severe axial neck pain. Spurling’s maneuver is positive bilaterally left greater than right. Symptoms are in the C6 and C7 dermatomes. She has some symptoms on the left upper extremity in the C8 distribution dermatomes. She has positive Tinel sign over the cubital tunnel on the left side.

• NuGen Surgical Transom Anterior Cervical Plating System
• NuGen Surgical Cavetto Cervical Cage System
• Physio Moldable 5cc DBM allograft

• ACDF C5 – C7

Follow Up

Occurred at 3 and 5 months after procedure.

At the 3 month follow up, the patient reported no neck or arm pain. X-rays taken and reviewed, included the AP and lateral views of the cervical spine. There is a plate and screw construct in position from C5 – C7. Interbody fusion cage appears to be consolidating nicely. There is some kyphosis above her fusion, but no osteolysis is seen surrounding the hardware.

This case typifies common pathology seen by spine care providers on a frequent basis. Having failed conservative treatments for a 3 year period consisting of physical therapy, chiropractic care, medications and injections, this patient was an excellent surgical candidate for this procedure. Surgery can in many cases provide palliation of preoperative pain. The NuGen Surgical Transom Anterior Cervical Plating System has been used in this instance to provide a stable construct, allowing for fusion to occur. It is a rigid construct with a simple, well visualized locking mechanism and extremely low profile to minimize dysphagia, engineered to facilitate minimum surgical exposure.

Refer to the Transom Cervical Plate System Instructions for Use for proper use, precautions, warnings, indications, and labeling.

Fellowship Trained Board Certified Orthopaedic Spine Surgeon
Teton Orthopaedics
Jackson Hole, Wyoming

Herniated Cervical Discs Cervical 5 – 7

Pre-Operative Diagnosis:

1. Cervical stenosis C5 – C7
2. Cervical radiculopathy

Patient is a 39 year old male with a longstanding history of neck pain with bilateral upper extremity radiculopathy. He sustained an injury to his cervical spine in a bridge collapse accident that occurred in December of 2012, where his truck fell into a creek bed. He had severe cervicogenic headaches. Cervical mobility is inhibited secondary to axial neck pain. Spurling’s maneuver is positive bilaterally. It causes symptoms in the C6 – C7 dermatomes. MRI shows severe cervical stenosis at C5 – C6 with a large left-sided disc herniation at C6 – C7.

• NuGen Surgical Transom Anterior Cervical Plating System
• NuGen Surgical Cavetto Cervical Cage System
• Physio Moldable 5cc DBM allograft

• ACDF C5 – C7

Follow Up

Occurred at 3 and 5 months after procedure.

At the 3 month follow up, the patient reported no neck or arm pain. X-rays taken and reviewed, included the AP and lateral views of the cervical spine. There is a plate and screw construct in position from C5 – C7. Interbody fusion cage appears to be consolidating nicely. There is some kyphosis above her fusion, but no osteolysis is seen surrounding the hardware.

This case typifies common pathology seen by spine care providers on a frequent basis. Having failed conservative treatments for a 3 year period consisting of physical therapy, chiropractic care, medications and injections, this patient was an excellent surgical candidate for this procedure. Surgery can in many cases provide palliation of preoperative pain. The NuGen Surgical Transom Anterior Cervical Plating System has been used in this instance to provide a stable construct, allowing for fusion to occur. It is a rigid construct with a simple, well visualized locking mechanism and extremely low profile to minimize dysphagia, engineered to facilitate minimum surgical exposure.

Refer to the Transom Cervical Plate System Instructions for Use for proper use, precautions, warnings, indications, and labeling.

Fellowship Trained Board Certified Orthopaedic Spine Surgeon
Teton Orthopaedics
Jackson Hole, Wyoming

Cervical Stenosis with Myelopathy Cervical 3 – 6

Pre-Operative Diagnosis:

1. Cervical stenosis C3 – C6
2. Cervical radiculopathy
3. Cervical myelopathy

Patient is a 69 year old woman with a long standing history of neck problems. She has experienced increasing clumsiness and myelopathy over the last several years.

• NuGen Surgical Transom Anterior Cervical Plating System
• NuGen Surgical Cavetto Cervical Cage System
• Physio Moldable 10cc DBM allograft

• ACDF C3 – C6

Follow Up

Occurred at 3 months and 6 months.

X-rays were reviewed including AP and lateral views of the cervical spine. There is a plate and screw construct in position from C3 – C6. Interbody fusion cages are well positioned. Bone graft is solidly consolidated. Hardware is well positioned with well-maintained lordosis. No osteolysis or loosening is appreciated.

In this case, the NuGen Surgical Transom Anterior Plating System is used to treat severe cervical stenosis in a patient with progressive cervical myelopathy. With dysphagia a frequent complaint following multilevel ACDF procedures, especially those extending to cervical 3, a low profile plate like the Transom is an excellent choice.

Refer to the Transom Cervical Plate System Instructions for Use for proper use, precautions, warnings, indications, and labeling.

Valley Presbyterian Hospital
Van Nuys, CA

Anterior cervical discectomy and instrumented fusion at C5 – C6 adjacent to previous C6 – C7 ACDF for adjacent segment disease.

Pre-Operative Diagnosis:

1. History of previous C6 – C7 ACDF with Transom cervical plate and structural allograft
2. C5 – C6 adjacent cervical disk disease and stenosis
3. Cervical radiculopathy

This is a case of a 43-year old female who previously underwent an anterior cervical discectomy and instrumented fusion at C6 – C7 for radiculopathy utilizing structural allograft with a Transom anterior cervical plate. She did well from this surgery but subsequently developed adjacent segment disease at C5 – C6 with stenosis and radiculopathy. MRI revealed a right paracentral herniation at C5 – C6. She failed a course of conservative measures including physical therapy, medications, and epidural injections. It was recommended that she undergo removal of the anterior hardware at C6 – C7, as this level was fused, coupled with an anterior cervical discectomy and instrumented fusion at C5 – C6.

• NuGen Surgical Cavetto Phusion Metal Cervical Interbody Cage System
• NuGen Surgical Transom Cervical Plate System
• Prosidyan FIBERGRAFT BG MATRIX

• Removal of anterior cervical plate at C6 – C7
• Anterior cervical interbody fusion with Cavetto Phusion Metal Cage
• Anterior cervical fusion with Transom Cervical Plate

Follow Up

At 2 week follow-up, the patient is already experiencing improvement in her radicular symptoms.

This case demonstrates adjacent segment disease next to a previously fused C6 – C7 level. Having failed conservative measures consisting of physical therapy, medications, and spinal injections, it was recommended that the patient undergo removal of the C6 – C7 hardware followed with an anterior cervical discectomy and instrumented fusion at C5 – C6 with the goal of alleviating her neck pain and radicular symptoms utilizing the Cavetto Phusion Metal Cage. This biomechanical intervertebral device provides stabilization to the spine while promoting intervertebral fusion.

Refer to the Cavetto Phusion Metal Cervical Interbody Cage System Instructions for Use for proper use, precautions, warnings, indications, and labeling.

NuGen Surgical, Inc. announces the 510(k) U.S. FDA clearance of the Oculus-SA Lumbar Cage System. The Oculus-SA System comprises of Oculus-SA cages and screws designed to optimize endplate contact and resist subsidence. The system uses a simple and unique One-Step locking mechanism to allow a Zero – Profile construct. Along with intuitive, ergonomic surgeon-friendly instrumentation, Oculus-SA provides a state of the art solution.

NuGen Surgical, Inc. received 510(k) clearance from the U.S. FDA to market the Trifore Anterior Cervical Plating System. This new technology cervical plate system incorporates more of NuGen Surgical, Inc. patented technologies allowing for a one-step locking mechanism with visual and tactile lock verification and screw height variances.

NuGen Surgical, Inc. announces the 510(k) U.S. FDA clearance of the Cortina PLIF cage IBF System. Bulleted (tissue dissecting) and Blunt nosed PEEK innerbody with intuitive and ergonomic surgeon friendly instrumentation. Cortina cages incorporate tantalum markers for clear intra-operative visualization.

Cavetto Phusion Metal

Phusion Metal is a proprietary and novel porous intermetallic compound that obtains an irregular open porous structure optimized for bone ingrowth. The elastic modulus of 0.7 – 1.3 GPa lies within the range of human cancellous bone. A low elastic modulus may preserve bone stock and reduce implant subsidence. Surface friction allows for initial stability and reduces the risk of implant migration. This unique and osteoconductive porous structure allows bone to grow throughout the irregular pores resulting in a more rapid and robust fusion.

Poly-ether-ether-ketone (PEEK), a high-performance radiolucent thermoplastic material with an elastic modulus of 4.1 GPa has been widely used for interbody cage devices over the past decade. However, PEEK is nonporous, provides limited cell response, has been known to form a fibrous connective interface and does not integrate well with bone.

The main objective of this study was to compare a proprietary Phusion Metal interbody fusion cage to a commercially available PEEK interbody fusion cage in an ovine lumbar interbody fusion model. We hypothesized that this open-celled and fully interconnected porous structure would encourage superior bone-to-implant contact and allow bone ingrowth throughout the pores in all directions with substantial implant incorporation, thus, resulting in a more rapid and robust fusion.

Eight sheep underwent an instrumented 2-level lumbar intervertebral fusion at L2-L3 and L4-L5. Each animal was implanted with two different types of interbody fusion cages: commercially approved PEEK cage with autologous bone graft; Phusion Metal cage with autologous bone graft. The animals were evenly divided into 2 time points on the basis of follow-up period; 4 months and 6 months.

Soft tissues (n=42) from heart, liver, lung, spleen, lymph node, and kidney were fixed, dehydrated, cleared, infiltrated, and embedded using standard paraffin histology techniques and equipment.

Sheep underwent lateral and dorsoventral lumbar radiographs as well as computed tomographic scans of the lumbar spine following immediate post-op and euthanasia.

Histological sections were stained with Sanderson’s Rapid Bone stain which provided differentiation of cells and allowed detection of cartilage within the tissue. Slides were then counterstained using a Van Gieson bone stain that allows differentiation of collagen and detection of bone. Histomorphometric measurements were made to quantify the area of new bone + fibrous reactive tissue + osteoid filling the pores of Phusion Metal.

Both the protocol and qualifications of the personnel involved in the study were reviewed and approved by the Institutional Animal Care and Use Committee (IACUC). This preclinical study has been performed in compliance with Good Laboratory Practice for Nonclinical Laboratory Studies (GLP) defined in the current FDA, 21 CFR 58.

No animals were lost or showed signs of infection, lameness or neurologic deficits throughout the study period. Histological analysis of soft tissues (n=42), including heart, liver, lung, spleen, kidney and lymph node was normal for conventionally raised sheep. There were no changes that were considered as potential toxic effects of the implants or procedures. Neither implant related issues nor migrations occurred throughout the study.

With regards to undecalcified bone sections, Phusion Metal demonstrated new reactive bone completely capping the vertebral endplates adjacent to the implants at 4-month and 6-month time points. Phusion Metal implants had less fibrous encapsulation compared to PEEK and had variable amounts of reactive bone directly in contact with the implant surface replacing the fibrous capsule (Figure 2 & Figure 3).

A comparison of radiographs and computed tomographic examinations at time=0 and at euthanasia showed neither signs of implant related issues nor migrations at 4 months and 6 months (Figure 5).

Surgical implantation was achieved in all animals without any adverse events. The wounds were all well-healed and normal ambulation recovery was noted in all animals. There were no adverse reactions to the organs. Radiographic and CT scan evaluation confirmed there was neither evidence of migration nor implant related issues at all time points. No evidence of any adverse reactions to the implants was noted throughout the study.

In an attempt to increase the bone remodeling properties of PEEK, a number of surface technologies have been recently introduced to the market. Although plasma-sprayed titanium coatings on PEEK have been shown to improve bone formation at the implant-bone interface, wear debris and delamination may occur during impaction. Solid titanium cages with a nano-textured surface improves bone ongrowth, however, they obtain high material stiffness with an elastic modulus of 110-115 GPa which may lead to increased subsidence rates.

Phusion Metal has several unique properties and potential advantages compared to PEEK and other surface coated intervertebral fusion cage materials. Phusion Metal® has an irregular porous structure with interconnected passageways that facilitates bone integration throughout the pores, thus, the material actively participates during the entire fusion process.
As seen in the histology images, this intermetallic compound promotes substantial through-growth of bone during the early stages of the healing cascade.

The preclinical GLP study demonstrates the osteoconductive and osseointegrative nature of Phusion Metal used in an interbody fusion ovine model. Unlike PEEK, the proprietary and novel Phusion Metal intermetallic material allowed for early osseointegration at the implant surface adjacent to both endplates and osteoconduction throughout the pores. Phusion Metal, a biocompatible and bone-friendly porous intermetallic compound, holds promise of more rapid and complete bone growth to improve overall spinal fusion outcomes.

Refer to the Phusion Metal Instructions for Use for proper use, precautions, warnings, indications, and labeling.