AccuLIF TL and PL Cage

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 July 8, 2016 Stryker Corporation Ms. Tina Mornak Regulatory Affairs Specialist 2 Pearl Court Allendale, New Jersey 07401 Re: K160715 Trade/Device Name: AccuLIF® TL and PL Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: June 9, 2016 Received: June 13, 2016 Dear Ms. Mornak: 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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set {1}------------------------------------------------ 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 Industry and Consumer Education 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. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Industry and Consumer Education 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 -S Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. 510(k) Number (if known) K160715 Page 1 of 1 Device Name AccuLIF® TL and PL Cage #### Indications for Use (Describe) The AccuLIF TL and PL Cages are indicated for intervertebral body fusion with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion in patients with degenerative disc disease (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 at the involved level(s). These patients should be skeletally mature and have completed six months of non-operative treatment. Additionally, the AccuLIF TL and PL Cages can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. The AccuLIF TL and PL Cages are always to be used with supplemental internal spinal fixation. Additionally, the AccuLIF TL and PL Cages are to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion. Type of Use (Select one or both, as applicable) | <div> <span style="text-decoration: overline;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | |---------------------------------------------------------------------------------------------------------------| | <div> <span>☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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." {3}------------------------------------------------ | Stryker Spine AccuLIF® TL and PL Cage 510(k) Summary | | |------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter | Stryker Spine | | | 2 Pearl Court | | | Allendale, NJ 07401 | | Contact Person | Aakash Jain | | | Regulatory Affairs Specialist | | | Phone: 201-749-8074 | | | Fax: 201-962-4074 | | | E-mail: aakash.jain@stryker.com | | Date Prepared | March 11, 2016 | | Trade Name | AccuLIF® TL and PL Cage | | Common Name | Intervertebral Fusion Device With Bone Graft, Lumbar | | Proposed Class | Class II | | Classification Name<br>and Number | Intervertebral body fusion device, 21 CFR 888.3080 | | Product Codes | MAX | | Predicate Devices | The AccuLIF® TL and PL Cage was shown to be substantially | | | equivalent to the device listed below: | | | Primary Predicate: Stryker Spine, AccuLIF® TL and PL Cage K152651 | | Device Description | The AccuLIF TL and PL Cage device is an expandable interbody fusion<br>cage manufactured from implant grade Titanium alloy (TI6Al4V ELI)<br>as per ASTM F136-08, Stainless Steel (316 LVM) as per ASTM F138-<br>08, and Silicone Rubber (MED-4870). As with the predicate expandable<br>AccuLIF TL and PL Cage devices, the device is inserted in unexpanded<br>state with a delivery handle and expanded in-situ to the required height<br>via 2 hydraulic cylinder and piston arrangements using a hydraulic<br>system comprising disposable flexible expansion tubing set and<br>inflation syringe. The device automatically locks at 1mm increments as<br>it expands. The AccuLIF TL and PL Cage come in a variety of sizes,<br>shapes, and lordotic angles to accommodate patient anatomy. | | Indications for Use | The AccuLIF TL and PL Cages are indicated for intervertebral body<br>fusion with autograft and/or allogenic bone graft comprised of<br>cancellous and/or corticocancellous bone graft when the subject device<br>is used as an adjunct to fusion in patients with degenerative disc disease<br>(DDD) at one level or two contiguous levels from L2 to S1. DDD is<br>defined as back pain of discogenic origin with degeneration of the disc<br>confirmed by history and radiographic studies. These DDD patients may<br>also have up to Grade I spondylolisthesis or retrolisthesis at the involved | | Summary of<br>Technological<br>Characteristics | level(s). These patients should be skeletally mature and have completed<br>six months of non-operative treatment.<br><br>Additionally, the AccuLIF TL and PL Cages can be used as an adjunct<br>to fusion in patients diagnosed with degenerative scoliosis.<br><br>The AccuLIF TL and PL Cages are always to be used with<br>supplemental internal spinal fixation. Additionally, the AccuLIF TL and<br>PL Cages are to be used with autograft and/or allogenic bone graft<br>comprised of cancellous and/or corticocancellous bone graft when the<br>subject device is used as an adjunct to fusion.<br><br>The purpose of this 510(k) is to introduce modifications to the AccuLIF<br>TL and PL Tubing Sets. There have been no changes to the AccuLIF TL<br>and PL Cage implants as a result of the proposed modifications to the<br>AccuLIF Tubing Sets. The AccuLIF TL and PL Cage and the predicate<br>device are both expandable, have similar design features, are both used<br>in the anterior column of the spine, and both use Titanium alloy as the<br>main device material.<br><br>The modified AccuLIF Tubing Sets continues to function as the<br>predicate - to deliver pressurized saline in order to expand the AccuLIF<br>TL and PL Cage implants. | | Summary of the<br>Performance Data | Design verification testing was conducted to assess the device<br>modification. The non-clinical test results demonstrate that the modified<br>device is substantially equivalent to the predicate. | | Conclusion | The modified accessory to the AccuLIF TL and PL Cage has identical<br>indications, technological characteristics, and principles of operation as<br>its predicate. Thus, the modified device was shown to be substantially<br>equivalent to the AccuLIF TL and PL Cage. | {4}------------------------------------------------