INFIX ANTERIOR LUMBAR SYSTEM

{0}------------------------------------------------ | | <b>510(k) SUMMARY</b><br>InFix® Anterior Lumbar System | |---------------------------------------------|------------------------------------------------------------------------------------------------------------| | Date of Summary Preparation: | December 20, 2013 | | Submitter: | Zimmer Spine, Inc.<br>7375 Bush Lake Road<br>Minneapolis, MN 55439<br>USA | | Establishment Registration Number: | 2184052 (Minneapolis) | | Company Contact (Primary): | Donna M. Semlak<br>Senior Regulatory Affairs Specialist<br>Office: 952.857.5643<br>Email Fax: 952.857.5843 | | Trade Name(s): | InFix® Anterior Lumbar System | | Device Name (Common Name): | Intervertebral Body Fusion Device<br>Vertebral Body Replacement | | Device Classification: | Class II | | Regulation Number(s) and<br>Product Code(s) | 21 CFR § 888.3080 / MAX<br>21 CFR § 888.3060 / MQP | {1}------------------------------------------------ #### Predicate Devices: Predicates are indicated to accommodate the indication for use for the subject InFix System, added indication for intervertebral body fusion device (IBFD) and retain the indication for vertebral body replacement (VBR). The subject InFix System is claimed to be substantially equivalent to the following legally marketed predicate devices in the following table. | InFix Anterior Lumbar Implant System<br>Predicate Device Names | Submission ID<br>Number | Clearance Date | |----------------------------------------------------------------------------------------------------|-------------------------|------------------| | InFix® Anterior Lumbar Device (System)<br>Original Applicant: Spinal Concepts<br>Product Code: MQP | K031672 | August 07, 2003 | | Ardis Spacer<br>Original Applicant: Abbott Spine<br>Product Code: MAX | K073202 | January 30, 2008 | #### General Device Description: The InFix System is comprised of implants and two configurations of instrumentation. The subject InFix implants are the same design and dimensions as those described in InFix System, VBR submission K031672. The InFix implant is comprised of two endplates and two struts, which are to be utilized together: with an optional endcap. The InFix System is provided in a range of angles and heights. including the instrumentation (accessories and instruments) necessary to implant the specific system. The current instrumentation is retained in aluminum trays. The new proposed instrumentation is retained in stainless trays. The InFix implant is manufactured from implantable grade Ti-6AL-4V alloy that conforms to ASTM F-136. The implant is comprised to two opposing Endplates (provided in 0°, 3°, 6° and 9° angles) supported by two vertical Struts available in a range of heights, allowing the surgeon to fix the vertebrae in proper anatomical alignment and lordosis. Each of the Struts includes a load-sharing mechanism that allows a limited amount of strain across the fusion mass while supporting the load bearing surfaces. An Ultra High Molecular Weight Polyethylene (UHMWPE) Endcap may be placed inside the implant prior to packing it with bone graft. The Endcap serves as an optional block of the posterior opening in the implant construct to assist in containing the material inside. Holes in the Endplates provide space for bone in-growth while angled spikes penetrate the vertebral endplates and provide resistance to rotation and migration. The InFix implant is designed for direct placement between two vertebral bodies. Component sizes and dimensions and the InFix implant depth, width and height are shown below. All dimensions are in millimeters. Strut heights are in 2mm increments. | Size | InFix Struts | InFix Endplates | | |--------|--------------|-----------------|------------| | | Heights (mm) | Depth (mm) | Width (mm) | | Small | 8-14 | 24 | 29 | | Medium | 8-14 | 26.5 | 32 | | Large | 8-14 | 29 | 35 | Image /page/1/Figure/11 description: The image shows two views of a cylindrical object with multiple holes. The left view shows the object from the front, with labels indicating the "DEPTH" at the top and "WIDTH" at the bottom. The right view shows the object from the side, with a label indicating the "HEIGHT" at the bottom. {2}------------------------------------------------ The InFix implant is assembled and locked in-sity; bone graft is then inserted within the device and up to the anterior rim of the vertebral body. InFix is implanted using a set of specialized instruments. The subject InFix System specialized instruments (stainless steel trays) are listed in the InFix Anterior Lumbar System Surgical Technique Guide. The current InFix System instruments (aluminum trays) are listed in the InFix Anterior Lumbar Device Surgical Technique Guide. Both instrumentation sets facilitate the insertion and removal of the InFix implants. The InFix implant is provided for single use only. #### Indications for Use: When us as a vertebral body replacement device, the InFix System is intended for use in the thoracic and/or lumbar spine (T3-L5) to replace a collapsed, damaged or unstable vertebral body resected or excised (i.e., partial vertebrectomy procedures) due to tumor or trauma (i.e., fracture). The InFix System is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. The InFix implant is intended to be used with bone graft. When used as an intervertebral body fusion device the InFix System is indicated for use with autogenous bone graft at one or two contiguous levels in the lumbosacral region (L2-S1) in the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients with previous non-fusion spinal surgery at involved level may be treated with the device. Patients should be skeletally mature and have had six months of non-operative treatment. When used as an intervertebral body fusion device, the InFix implant is intended to be used with supplemental fixation. For both of the indications listed above, the InFix implant is intended to be implanted via an open anterior approach. #### Summary of Technological Characteristics: The InFix System shares the same technological characteristics its predicate device. InFix System, Anterior Lumbar Device (K031672), The technological characteristics include the same intended use as spinal spacers, the same mechanical and functional design; the same range of sizes, materials and the same substantially equivalent performance characteristics. Ardis (K073202) was selected as predicate device because it already obtain the IBFD indications and have similar technological characteristics. The subject and predicate implant are a hollow taper design in various height, width and length options, which provides space for bone in-growth. Implants provided for single use only. InFix System and the predicates are implanted using a set of specialized instruments. These instruments facilitate the access, insertion and removal of the implants. #### Summary of Performance Testing: Non-clinical testing included components of the proposed InFix System were reviewed and tested appropriately for design controls; i.e. design verification. The test results conclude the InFix System to be substantially equivalent to the predicate devices. In-Fix and Ardis. {3}------------------------------------------------ - · Bench Testing for Vertebral Body Replacement (VBR) was conducted per ASTM F2077 for Static and Dynamic Torsion, Static and Dynamic Compression Bending confirming the In-Fix implant performance is acceptable for its intended use; the same intended use as the predicate device InFix. - Additional Bench Testing for Intervertebral Body Fusion Device (IBFD) was conducted . per ASTM F2077 for Static and Dynamic Compression Shear, which included Subsidence testing per ASTM F2267 confirming the InFix implant performance is acceptable for its intended use; the same intended use as the predicate device, Ardis. - . Cadaver testing is conducted to ensure the InFix System performs as intended and to ensure substantially equivalent to the predicate devices. - Sterilization is conducted under ISO 17665 and AAMI TIR12, to ensure substantially . equivalent to the predicate devices. Dry time and cleaning instructions were also assessed. - Biocompatibility Assessment per ISO 10993-1 was conducted to ensure the InFix System . materials are biocompatible based on the same materials to the predicate devices. The InFix System testing concluded the performance, intended use and fundamental scientific technology of the Infix implant remains unchanged and is substantially equivalent to the predicate, InFix and Ardis devices. #### Substantial Equivalence: Zimmer Spine considers the subject (nFix System product performance to be substantially equivalent to the predicate; InFix and Ardis devices because they are used to treat the same conditions, represent a basic design concept in terms of safety and effectiveness. There is no change to the implant mechanical performance, no change to the device functional scientific technology and testing supports the addition of the proposed Intervertebral Body Fusion Device indication. {4}------------------------------------------------ #### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle-like symbol with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 December 20, 2013 Zimmer Spine, Incorporated Ms. Donna M. Semlak Senior Regulatory Affairs Specialist 7375 Bush Lake Road Minneapolis, Minnesota 55439 Re: K132790 Trade/Device Name: InFix® System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX, MQP Dated: September 26, 2013 Received: September 27, 2013 Dear Ms. Semlak: 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 (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. 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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set {5}------------------------------------------------ ### Page 2 - Ms. Donna M. Semlak forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (2) CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, # Ronald#Wean -S for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ ## REVISED Dec 10, 2013 INDICATIONS FOR USE STATEMENT K132790 510(k) Number (if known) Device Name(s): InFix® System Indications for Use When used as a vertebral body replacement device, the InFix® System is intended for use in the thoracic and/or lumbar spine (T3-L5) to replace a collapsed, damaged or unstable vertebral body resected or excised (i.e., partial vertebrectomy procedures) due to tumor or trauma (i.e., fracture). The InFix is designed to restore the biomechanical integrity of the anterior and middle spinal column even in the absence of fusion for a prolonged period. The InFix implant is intended to be used with bone graft. When used as an intervertebral body fusion device the InFix System is indicated for use with autogenous bone graft at one or two contiguous levels in the lumbosacral region (L2-S1) in the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients with previous non-fusion spinal surgery at involved level may be treated with the device. Patients should be skeletally mature and have had six months of nonoperative treatment. When used as an intervertebral body fusion device, the InFix implant is intended to be used with supplemental fixation. For both of the indications listed above, the InFix implant is intended to be implanted via an open anterior approach. Prescription Use AND/OR (Part 21 CFR 801 Subpart D) Over-the Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Anton E. Dmitriev, PhD Division of Orthopedic Devices