Invictus® Spinal Fixation System

{0}------------------------------------------------ September 27, 2023 Image /page/0/Picture/1 description: The image contains two logos. On the left is the Department of Health & Human Services logo, which features a stylized caduceus. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. Alphatec Spine, Inc. Cynthia Dorne Sr. Manager, Regulatory Affairs 1950 Camino Vida Roble Carlsbad, California 92008 Re: K232275 Trade/Device Name: Invictus® Spinal Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB, KWP, PML, KWQ, OUR Dated: July 28, 2023 Received: July 31, 2023 Dear Cynthia Dorne: We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). {1}------------------------------------------------ Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Eileen Digitally signed by Eileen Cadel - S Cadel -S Date: 2023.09.27 16:41:07 -04'00' for Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K232275 Device Name Invictus® Spinal Fixation System ### Indications for Use (Describe) The Invictus Spinal Fixation System is intended for non-cervical posterior and anterolateral fixation in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenc origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis (i.e., scoliosis, kyphosis); tumor; pseudarthrosis; and/or failed previous fusion. When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Invictus Spinal Fixation System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Invictus Spinal Fixation System is intended to treat pediatic patients diagnosed with the following conditions: spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. Pediatic pedicle screw fixation is limited to a posterior approach. The Invictus Spinal Fixation System is intended to be used with autograft and/or allograft. Invictus SI.CORE Screws are intended for sacroiliac joint fusion for the following conditions: · Sacroliac joint dysfunction that is a direct result of sacrolliac joint disruption and degenerative sacroilitis. This includes conditions whose symptoms began during pregnancy or in the period and have persisted postpartum for more than 6 months. · To augment immobilization and stabilization of the sacroiliac joint in skeletally mature patropelvic fixation as part of a lumbar or thoracolumbar fusion. · Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint. Invictus CORE and Invictus SI.CORE Screws are not intended for use with cement; all other fenestrated screws may be used with Invictus Bone Cement. When used in conjunction with Invictus Bone Cement, the Invictus Fenestrated Screws are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. The Invictus Fenestrated Screws augmented with Invictus Bone Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised. Type of Use (Select one or both, as applicable) | | Prescription Use (Part 21 CFR 801 Subpart D) | |--|----------------------------------------------| | | Over-The-Counter Use (21 CFR 801 Subpart C) | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. {3}------------------------------------------------ This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the word "atec" in a stylized font. The "a" is green and looks like a handwritten letter. The rest of the letters are black. There is a trademark symbol to the right of the "c". There is a black line underneath the word. This 510(k) summary of safety and effectiveness is being submitted in accordance with the requirements of 21 CFR 807.92. | I. | SUBMITTER: | Alphatec Spine, Inc.<br>1950 Camino Vida Roble<br>Carlsbad, CA 92008<br>Phone: (760) 431-9286<br>Fax: (760) 431-0289 | |-----|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Contact Person: | Cynthia Dorne<br>Sr. Manager, Regulatory Affairs<br>Contact Phone: (760) 494-6740 | | | Date Summary Prepared: | July 28, 2023 | | II. | DEVICE | | | | Name of Device:<br>Common or Usual Name: | Invictus® Spinal Fixation System<br>Thoracolumbosacral Pedicle Screw System<br>Spinal Interlaminal Fixation System<br>Bone Cement<br>Metallic Bone Fixation Fastener | | | Classification Name: | Thoracolumbosacral Pedicle Screw System (21 CFR<br>888.3070)<br>Spinal Interlaminal Fixation Orthosis (21 CFR<br>888.3050)<br>Polymethylmethacrylate (PMMA) bone cement (21<br>CFR 888.3027)<br>Spinal Intervertebral Body Fixation Orthosis (21 | #### III. LEGALLY MARKETED PREDICATE DEVICES Regulatory Class: Product Code: | 510(k) | Product Code | Trade Name | Manufacturer | |------------------------------|-------------------------------|-----------------------------------------------------------|----------------| | Primary Predicate Device | | | | | K222774 | OUR, NKB,<br>OLO | iFuse Bedrock Granite Implant<br>System | SI-BONE | | Additional Predicate Devices | | | | | K221926 | OUR, NKB,<br>KWP, PML,<br>KWQ | Invictus® Bone Cement, Invictus<br>Spinal Fixation System | Alphatec Spine | CFR 888.3060) Class II Fastener (21 CFR 888.3040) NKB, KWP, PML, KWQ, OUR Smooth or Threaded Metallic Bone Fixation {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the word "atec" in a stylized font. The "a" is green, while the "tec" is dark blue. There is a trademark symbol in the upper right corner of the "c". The font is sans-serif and appears to be a custom design. | 510(k) | Product Code | Trade Name | Manufacturer | |---------|-----------------------|-----------------------|---------------------------| | K140738 | MNI, MNH,<br>KWP, OSH | Pass LP Spinal System | Medicrea<br>International | #### IV. DEVICE DESCRIPTION The Invictus Spinal Fixation System is thoracolumbosacral spinal fixation system designed to be implanted through a non-cervical posterior or anterolateral surgical approach. The implants are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F136, commercially pure titanium (CP Ti Grade 2) per ASTM F67 and cobalt chromium (Co-28Cr-6Mo) alloy per ASTM F1537. The Invictus System consists of a variety of shapes and sizes of screws, hooks, rods, connectors, and cross-connectors to create a rigid construct as an adjunct to fusion for temporary internal fixation and stabilization of the thoracic, lumbar and sacral spine. Invictus SI.CORE bone screws are intended to provide sacroiliac joint fusion in sacral alar iliac (SAI) trajectories. Invictus Core and Invictus SI.Core Screws are not intended for use with cement; all other fenestrated screws may be with Invictus Bone Cement, a self-hardening and ready to use used polymethylmethacrylate (PMMA) bone cement with a high amount of radiopaque agent for percutaneous vertebroplasty. The Invictus Patient Specific Rods are used to connect pedicle screws, hooks, and connectors across different levels of vertebral bodies to create a rigid construct. They are intended to be used with standard Invictus instrumentation. The Invictus Patient Specific Rods are available in 05.5 mm and 6.0 mm diameters and will be provided in lengths between 20 - 600 mm. Equivalent to cleared Invictus rod materials, the rods are made from five different materials: Commercially Pure Titanium (CP Ti Grade 4), Titanium Alloy (Ti-6Al-4V ELI), and three different formulations of Cobalt Chromium (Co-28Cr-6Mo). All Invictus Patient Specific Rods are provided pre-contoured to the surgeon's plan based on the patient's anatomy by means of an industrial bending process prior to distribution for surgery. There is no need for additional bending during surgery. The purpose of this submission is to expand indications for use of Invictus SI.CORE screws as sacroiliac joint fusion devices, and to add a range of Invictus Patient-Specific Rods to the Invictus Spinal Fixation System. #### V. INDICATIONS FOR USE The Invictus Spinal Fixation System is intended for non-cervical posterior and anterolateral fixation in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion. When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Invictus Spinal Fixation System implants are indicated as an adjunct to fusion to treat {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the logo for "atec". The "a" is green, and the rest of the letters are black. There is a black line underneath the logo. progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Invictus Spinal Fixation System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis / spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. Pedicle screw fixation is limited to a posterior approach. The Invictus Spinal Fixation System is intended to be used with autograft and/or allograft. Invictus SI.CORE Screws are intended for sacroiliac joint fusion for the following conditions: - . Sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months. - . To augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion. - Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint. . Invictus CORE and Invictus SI.CORE Screws are not intended for use with cement; all other fenestrated screws may be used with Invictus Bone Cement. When used in conjunction with Invictus Bone Cement, the Invictus Fenestrated Screws are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. The Invictus Fenestrated Screws augmented with Invictus Bone Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised. #### TECHNOLOGICAL COMPARISON TO PREDICATES VI. The technological design features of the subject implants were compared to the predicates in intended use, indications for use, design, function and technology and it was demonstrated that they are substantially equivalent. #### VII. PERFORMANCE DATA Engineering analysis and rationale was provided to demonstrate that the subject Invictus Spinal Fixation System is substantially equivalent to the predicate Invictus Spinal Fixation System. ## Clinical Information Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data. {7}------------------------------------------------ Image /page/7/Picture/1 description: The image shows the logo for "atec". The "a" is green and the "tec" is dark blue. There is a trademark symbol in the upper right corner of the "c". There is a black line underneath the logo. Traditional 510(k) Premarket Notification Invictus® Spinal Fixation System # VIII. CONCLUSION Based upon the information provided in this 510(k) submission it has been determined that the subject devices are substantially equivalent to legally marketed devices in regard to indications for use, intended use, design, technology, and performance.