ACCULIF TL-PEEK CAGE

{0}------------------------------------------------ # JAN 2 3 2013 # 510(k) Summary | Submitted By: | CoAlign Innovations<br>150 North Hill Drive, Suite 1<br>Brisbane, CA 94005 | |---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------| | Establishment<br>Registration Number: | 10030843 | | Contact Person:<br>(Submission Prepared by) | Justin Eggleton<br>Musculoskeletal Clinical & Regulatory Advisers, LLC<br>1331 H Street NW, 12th Floor<br>Washington, DC 20005<br>202.552.5800 | | Date Prepared: | October 19, 2012 | | Device Trade Name: | AccuLIF® TL-PEEK Cage | | Manufacturer: | CoAlign Innovations, Inc.<br>150 North Hill Drive, Suite 1<br>Brisbane, CA 94005 | | Common Name: | Spinal intervertebral body fixation orthosis | | Classification: | 21 CFR §888.3080 | | Class: | II | | Product Code: | MAX | #### Device Description: The AccuLIF TL-PEEK Cage acts as a spacer to maintain proper intervertebral spacing and angulation following discectomy. The AccuLIF TL-PEEK Cage is manufactured from Tl6Al4V ELI) as per ASTM F136-08, Stainless Steel (316 LVM) as per ASTM F138-08, PEEK (Invibio Optima LT1) as per ASTM F2026-07, and Silicone Rubber (MED-4870). The device is inserted in unexpanded state with an articulating delivery handle and expanded in-situ to the required height via 2 hydraulic cylinder and piston arrangement using a hydraulic system comprising disposable flexible expansion tubing set and inflation syringe. The device locks in 1mm increments as it expands. The AccuLIF Cage comes in 6 to 9mm, 8 to 12mm and 10 to 16mm sizes. The device has fixation ridges on the top and bottom surface. It also has a graft opening window which extends from the bottom surface to the top surface. The device has a proximal boss {1}------------------------------------------------ which has a threaded connection port for connecting to the inserter and a fluid port for transporting the expansion fluid ## Indications For Use: Intervertebral Body Fusion Device: The CoAlign Innovations AccuLIF TL-PEEK Cage is indicated for intervertebral body fusion with autogenous bone graft material in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to SI. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondvlolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have completed six months of non-operative treatment. The CoAlign Innovations AccuLIF TL-PEEK Cage is always to be used with supplemental internal spinal fixation. Additionally, the CoAlign Innovations AccuLIF TL-PEEK Cage is to be used with autogenous bone graft. #### Identification of Predicates - AccuLIF TL-PEEK Cage (K112095) * - AccuLIF TL Cage (K1216835) - - -AccuLIF TL Cage (K113465) ## Summary of Technological Characteristics AccuLIF TL-PEEK Cages are expandable spacers made from Titanium-6AL-4V ELI alloy that conforms to ASTM F136 and PEEK (Invibio Optima LT1) that conforms to ASTM F2026-07. The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically the following characteristics are identical between the subject and predicates: - -Indications for Use - Materials of manufacture - Expansion mechanism - - Structural support mechanism - #### Discussion of Testing: The following non-clinical tests were conducted: - Dynamic compression testing, conducted in accordance . with ASTM F2077-03 - Dynamic shear testing, conducted in accordance with -ASTM F2077-03 - Static compression testing, conducted in accordance with ASTM F2077-03 - Static shear testing, conducted in accordance with -ASTM F2077-03 - Static Subsidence testing, conducted in accordance with -ASTM F2267-04 - Static Expulsion testing, conducted in accordance with -ASTM Draft Standard F-04.25.02.02 {2}------------------------------------------------ Surgical technique validation, conducted in the same manner as the predicate surgical technique validation. ## Conclusions: The subject and predicate devices share the same indications for use, design, function, and materials of manufacture. The non-clinical test results demonstrate that any minor differences do not impact device performance as compared to the predicates. The AccuLIF TL-PEEK Cage was shown to be substantially equivalent to the AccuLIF-PEEK Cage (K112095) and the AccuLIF TL Cage (K1216835 and K113465). {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus symbol. The logo is simple, using a single color, and is designed to be easily recognizable. # DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 CoAlign Innovations, Incorporated % Musculoskeletal Clinical Regulatory Advisers, LLC Mr. Justin Eggleton Director, Spine Regulatory Affairs 1331 H Street NW, 12th Floor Washington, DC 20005 Re: K123281 Trade/Device Name: AccuLIF TL-PEEK Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX -Dated: October 19, 2012 Received: November 13, 2012 Dear Mr. Eggleton: 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 or any recently 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 Letter dated: January 23, 2013 {4}------------------------------------------------ ## Page 2 - Mr. Justin Eggleton device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set device-related adverse events) (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (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 11 you ucsire specific ad rios 10. Jour For your Centers Offices/CDRH/CDRHOffices/ucm115809.htm for go to inter/for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please the Center for Devices and readions by reference to premarket notification" (21CFR Part Ilote the regulation entined. "Informansing 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 I ou may ootan other general meetings 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, Mark N. Melkerson Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ # Indications for Use 510(k) Number (if known): _K123281 Device Name: AccuLIF TL-PEEK Cage Intervertebral Body Fusion Device: The CoAlign Innovations AccuLIF TL-PEEK Cage is indicated for intervertebral body fusion with autogenous bone graft material in patients with mercured for like. Forcertand DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have completed six months of non-operative treatment. The CoAlign Innovations AccuLIF TL-PEEK Cage is always to be used with supplemental internal spinal fixation. Additionally, the CoAlign Innovations AccuLIF TL-PEEK Cage is to be used with autogenous bone graft. Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) # Stephanie Begchtold -S (Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K123281