Tritanium® 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" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, layered on top of each other to create a sense of depth and unity. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 November 9, 2016 Stryker Spine Ms. Deirdre Jayko Regulatory Affairs Associate 2 Pearl Court Allendale, New Jersey 07401 Re: K162262 Trade/Device Name: Tritanium® PL Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: August 10, 2016 Received: August 11, 2016 Dear Ms. Jayko: 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set 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. {1}------------------------------------------------ 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" (21 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 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, # Lori A. Wiggins -S for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K162262 Device Name Tritanium® PL Cage #### Indications for Use (Describe) The Stryker Spine Tritanium® PL Cage is an intervertebral body fusion device indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when 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. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy. Additionally, the Tritanium® PL Cage can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. The Tritanium® PL Cage is to be implanted via a posterior approach. The Tritanium® PL Cage is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine. Type of Use (Select one or both, as applicable) | <div> <span> <span style="font-size:16px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </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}------------------------------------------------ | 510(k) Summary as required by 21 CFR §807.92(c).<br>Tritanium® PL Cage | | | |------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | Submitted by | Stryker Spine<br>2 Pearl Court<br>Allendale, New Jersey 07401 | | | Contact Person | Deirdre Jayko<br>Regulatory Affairs Associate<br>Phone: 201-749-8339<br>Email: deirdre.jayko@stryker.com | | | Date Prepared | November 4, 2016 | | | Common Name | Intervertebral body fusion device | | | Trade Name | Tritanium® PL Cage | | | Proposed Class | Class II | | | Classification Name<br>and Number | Intervertebral body fusion device, 21 CFR §888.3080 | | | Product Code | MAX: Intervertebral Body Fusion Device with Bone Graft, Lumbar | | | Predicate Devices | Legally marketed predicate devices to which substantial<br>equivalence is claimed:<br>Primary predicate:<br>Stryker Spine Tritanium ® PL (K160955) Additional predicates:<br>Stryker Spine AVS® PL and AVS® UniLIF™ (K151726)<br>Stryker Spine AVS® ALign (K151726) | | | Device Description | The purpose of this submission is to introduce new implant sizes<br>to the previously cleared Tritanium® PL Cage offering.<br>The Tritanium® PL Intervertebral Body Fusion Cage is intended<br>for use as an aid in lumbar spinal fixation. The cage is a hollow,<br>rectangular implant that consists of a unique configuration of both<br>solid and porous structures that are simultaneously built using<br>Laser Rapid Manufacturing (LRM) method applying Stryker's<br>proprietary Tritanium® In-Growth Technology. The cage is<br>offered in a variety of lengths, heights, widths and lordotic angles<br>to adapt to a variety of patient anatomies. It has serrations on the<br>superior and inferior porous surfaces of the implant for fixation,<br>an ergonomically shaped anterior edge, and a flat posterior edge.<br>The implant is designed to be used with supplemental fixation<br>cleared for use in the lumbosacral spine.<br>The Tritanium® PL cages are constructed from Titanium alloy: Ti-<br>6Al-4V (ASTM F1472-08) and are provided sterile. | | | Intended Use and<br>Indications for Use | The Stryker Spine Tritanium® PL cage is an intervertebral body<br>fusion device indicated for use with autograft and/or allogenic<br>bone graft comprised of cancellous and/or corticocancellous bone<br>graft when used as an adjunct to fusion in patients with<br>degenerative disc disease (DDD) at one level or two contiguous<br>levels from L2 to S1.<br>DDD is defined as back pain of discogenic origin with degeneration | | | 510(k) Summary as required by 21 CFR §807.92(c).<br>Tritanium® PL Cage | | | | | of the disc confirmed by history and radiographic studies. The<br>DDD patients may also have up to Grade I spondylolisthesis at the<br>involved level(s). These patients should be skeletally mature and<br>have six months of nonoperative therapy.<br>Additionally, the Tritanium® PL Cage can be used as an adjunct to<br>fusion in patients diagnosed with degenerative scoliosis.<br>The Tritanium® PL Cage is to be implanted via a posterior<br>approach.<br>The Tritanium® PL Cage is intended to be used with supplemental<br>spinal fixation systems that have been cleared for use in the<br>lumbosacral spine. | | | Summary of the<br>Technological<br>Characteristics | The subject Tritanium® PL Cages share the same materials, design<br>characteristics, and fundamental scientific technologies as the<br>predicate Tritanium® PL Cages. The purpose of this submission is<br>to introduce new implant sizes to the previously cleared<br>Tritanium® PL Cages offering. The subject devices and the<br>predicates share similar design features:<br>• Graft windows for packing autogenous bone<br>• Serrations on the superior and inferior surfaces<br>• Comparable heights, widths, depths, lordotic angles, and<br>material | | | Summary of<br>Non-Clinical Testing | Testing in compliance with:<br>FDA's June 12, 2007 "Class II Special Controls Guidance Document:<br>Intervertebral Body Fusion Device" was performed for the subject<br>Tritanium® PL Cages and demonstrated substantially equivalent<br>performance to the identified predicate devices.<br>The following mechanical tests were performed:<br>• Static and Dynamic Compression (per ASTM F2077)<br>• Static and Dynamic Compression Shear (per ASTM F2077)<br>• Static and Dynamic Torsion (per ASTM F2077)<br>• Expulsion (per ASTM F04-25-02-02 Draft)<br>• Subsidence (per ASTM F2267)<br>• Wear Debris Assessment, and<br>• Impaction<br>Bacterial endotoxin testing (BET) as specified in ANSI/AAMI<br>ST72:2011 is used for pyrogenicity testing to achieve the<br>Endotoxin limit of < 20EU/Device. | | | Conclusion | Based on the design features, the use of established well known<br>materials, feature comparisons, indications for use, and results of<br>the mechanical testing, the subject Tritanium® PL Cages have<br>demonstrated substantial equivalence to the identified predicate<br>devices. | | {4}------------------------------------------------