KEYSTONE PEEK Cage System

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text. September 21, 2021 Shanghai Sanyou Medical Co, LTD % Christine Scifert Partner MRC Global, LLC 9085 E. Mineral Cir., Suite 110 Centennial, Colorado 80112 Re: K211689 Trade/Device Name: KEYSTONE PEEK Cage System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: August 10, 2021 Received: August 11, 2021 Dear Christine Scifert: 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. 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 located 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. {1}------------------------------------------------ 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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-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. for Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K211689 Device Name KEYSTONE PEEK Cage System #### Indications for Use (Describe) The KEYSTONE PEEK Cage System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2 toS1 whose condition requires use of interbody fusion combined with supplemental fixation. DDD patients may also have up to Grade 1 Spondylolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Additionally, the KEYSTONE PEEK Cage System can be used to provide anterior column support in patients diagnosed with degenerative scoliosis as an adjunct to pedicle screw fixation. Patients should have had six months of non-operative treatment prior to surgery. The KEYSTONE PEEK Cage System is intended to be used with autograft and/or allogenic bone graft comprised of cancellous bone graft when the subject device is used as an adjunct to fusion. When used for these indications, the KEYSTONE PEEK Cage System is intended for use with supplemental fixation systems cleared for use in the lumbar spine. These implanted via a minimally invasive lateral approach. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------| | <span style="text-decoration: underline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="text-decoration: underline;"> </span> Over-The-Counter Use (21 CFR 801 Subpart C) | # 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 KEYSTONE PEEK Cage System 17 September 2021 | Company: | Manufacturing Facility and Headquarters:<br>Shanghai Sanyou Medical Co, LTD<br>385 Huirong Road, Jiading District,<br>Shanghai 201815<br>Phone: 021-58389980<br>Manufacturing Facility:<br>Shanghai Sanyou Medical Co, LTD<br>385 Huirong Road, Jiading District,<br>Shanghai 201815<br>Phone: 021-58389980 | |-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Company Contact: | David Fan<br>VP Marketing<br>david.fan@sanyou-medical.com<br>Phone: +86 21 58389980<br>Fax: +86 21 38682915 | | Official Correspondent: | Christine Scifert - MRC Global, LLC<br>Christine.scifert@askmrcglobal.com<br>901-831-8053 | | Trade Name: | KEYSTONE PEEK Cage System | | Common Name: | Intervertebral Fusion Device With Bone Graft, Lumbar | | Classification: | Class II | | Regulation Number: | 21 CFR 888.3080 (Intervertebral body fusion device) | | Panel: | Orthopedic | | Product Code: | MAX | #### Device Description: KEYSTONE PEEK Cage System consists of lumbar intervertebral body fusion devices (IBDs), provided in parallel or lordotic options with varying footprints to accommodate patient anatomy. The subject KEYSTONE cages (IBDs) contain serrations across both superior and inferior surfaces {4}------------------------------------------------ to allow the implant to grip the superior and inferior end plates to provide expulsion resistance. Subject devices are manufactured from medical grade polyetheretherketone (PEEK) material per ASTM F2026 and contain radiopaque tantalum pin markers per ASTM F560 for imaging purposes. The subject implants are to be inserted via a crenel-lateral (CLIF) approach. #### Indications for Use: The KEYSTONE PEEK Cage System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2 toS1 whose condition requires use of interbody fusion combined with supplemental fixation. DDD patients may also have up to Grade 1 Spondylolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Additionally, the KEYSTONE PEEK Cage System can be used to provide anterior column support in patients diagnosed with degenerative scoliosis as an adjunct to pedicle screw fixation. Patients should have had six months of non-operative treatment prior to surgery. The KEYSTONE PEEK Cage System is intended 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. When used for these indications, the KEYSTONE PEEK Cage System is intended for use with supplemental fixation systems cleared for use in the lumbar spine. These implants may be implanted via a minimally invasive lateral approach. ### Substantial Equivalence: The subject KEYSTONE PEEK Cage System is substantially equivalent to the following predicate devices: #### Primary Predicate: - Medtronic, CLYDESDALE® Spinal System: K083026, K132897, K151128 #### Secondary Predicates: - Shanghai Sanyou PEEK Cage System Halis Cage: K163422 There are insignificant differences between the subject KEYSTONE PEEK Cage System and the predicates. The Indications for Use, Materials, and Geometry for predicate devices are all inclusive of the subject device. Testing shows that the subject KEYSTONE PEEK Cage System performs equivalent to or better than the predicate devices. Thus, it can be concluded that the subject does not raise new questions about safety and effectiveness. #### Performance Testing: Bench performance testing was performed on the subject KEYSTONE PEEK Cage System implants including dynamic axial compression per ASTM F2077-14. #### Conclusion: Based on the test results and the comparison to the predicate devices, the subject device is determined to be substantially equivalent to the predicate devices.