ostaPek Interbody Fusion Cages

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows 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 is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION". November 14, 2018 coLigne, AG % J.D. Webb The OrthoMedix Group, Inc. 1001 Oakwood Blvd Round Rock, Texas 78681 Re: K181963 Trade/Device Name: ostaPek Interbody Fusion Cages Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: October 19, 2018 Received: October 22, 2018 Dear Mr. Webb: 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. 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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 {1}------------------------------------------------ devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. 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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Katherine D. Kavlock -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) K181963 Device Name ostaPek Interbody Fusion Cages #### Indications for Use (Describe) The ostaPek Interbody Fusion Cages system is indicated for use as an intervertebral body fusion device in skettally mature patients at one or two contiguous levels of the sacrolumbar spine (L2-S1) to facilitate fusion in case of degenerative disc disease (DDD) defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The ostaPek Interbody Fusion Cages are placed via an anterior, posterior or lateral approach using autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft. The ostaPek Interbody Fusion Cages are to be used with supplemental fixation cleared by the FDA for use in the lumbar spine. Patients should have at least six months of non-operative treatment prior to surgery. Patients with previous non-fusion spinal surgery at involved level may be treated with the device. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| |-------------------------------------------------|--| X Prescription Use (Part 21 CFR 801 Subpart D) 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: ostaPek Interbody Fusion Cages | Date Prepared | October 16, 2018 | |--------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitted By | Coligne, AG<br>Utoquai 43<br>Zurich, SWITZERLAND 8008<br>email: Robert.Lange@coligne.com | | Primary Contact | J.D. Webb<br>1001 Oakwood Blvd<br>Round Rock, TX 78681<br>512-388-0199 Tele<br>e-mail: jdwebb@orthomedix.net | | Trade Name | ostaPek Interbody Fusion Cages | | Common Name | Intervertebral Body Fusion Device | | Classification Name | Intervertebral Body Fusion Device with Bone Graft, Lumbar | | Class | II | | Product Code | MAX | | CFR Section | 21 CFR section 888.3080 | | Device Panel | Orthopedic | | Primary Predicate<br>Device | Brantigan I/F Cage, DePuy Spine (P960025) | | Secondary Predicate<br>Devices | Lumbar Interbody Fusion Cage System, L&K Biomed (K110783/K151140)<br>BAK Interbody Fusion System, Zimmer Spine (P950002) | | Reference Predicate<br>Devices | Ray Threaded Lumbar Fusion Cage, Stryker (P950019)<br>Talos PLIF, MediTech (K090707)<br>ACIF implants, Coligne AG (K173148)<br>ostaPek® VBR System, Coligne AG (K072326) | | Device Description | The ostaPek Interbody Fusion Cages system consists of four families of cages used with<br>four surgical approaches: the Erriva® ELIF/TLIF Cage (Extraforaminal Lumbar Interbody<br>Fusion/ Transforaminal Lumbar Interbody Fusion), the Gemitra® TLIF Cage, the PLIF<br>Cage (Posterior Lumbar Interbody Fusion) and PLIF Bullet Cage, and the ALIF Cage<br>(Anterior Lumbar Interbody Fusion).<br>All device configurations are available in multiple sizes to adequately fit patient anatomical<br>variations. They all have bone graft windows, ridges or teeth to resist migration, and x-ray<br>markers. | | Materials | Poly-ether-ketone-ether-ketone-ketone (PEKEKK) resin (ASTM F1876)<br>Carbon fiber filaments<br>Gold (ASTM B562) | | Intended Use | The ostaPek Interbody Fusion Cages system is used to maintain disc space distraction<br>and structural stability until fusion occurs in skeletally mature adults requiring lumbar<br>interbody fusion. | | Substantial<br>Equivalence Claimed<br>to Predicate Devices | The ostaPek Interbody Fusion Cages are substantially equivalent to the predicate devices<br>in terms of intended use, design, materials used, mechanical safety and performances. | | Indications for Use | The ostaPek Interbody Fusion Cages system is indicated for use as an intervertebral body<br>fusion device in skeletally mature patients at one or two contiguous levels of the sacro-<br>lumbar spine (L2-S1) to facilitate fusion in case of degenerative disc disease (DDD)<br>defined as discogenic pain with degeneration of the disc confirmed by patient history and<br>radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or<br>retrolisthesis at the involved level(s). The ostaPek Interbody Fusion Cages are placed via<br>an anterior, posterior or lateral approach using autogenous bone graft and/or allograft<br>comprised of cancellous and/or corticocancellous bone graft. The ostaPek Interbody<br>Fusion Cages are to be used with supplemental fixation cleared by the FDA for use in the<br>lumbar spine. Patients should have at least six months of non-operative treatment prior<br>to surgery. Patients with previous non-fusion spinal surgery at involved level may be<br>treated with the device. | | Summary of the<br>technological<br>characteristics<br>compared to<br>predicate | Intended Use<br>The ostaPek Interbody Fusion Cages and all the predicates have similar intended uses.<br>Materials<br>The ostaPek Interbody Fusion Cages are fabricated of the same material as the predicate<br>device.<br>Design Features/Functions<br>The ostaPek Interbody Fusion Cages and cited predicate devices share similar basic<br>design features and functions.<br>Dimensions<br>The ostaPek Interbody Fusion Cages system is dimensionally similar to cited predicate<br>devices.<br>Sterilization<br>The ostaPek Interbody Fusion Cages system is provided non-sterile and cited predicate<br>devices are non-sterile for single use only.<br>Performance Specification<br>Mechanical testing confirmed the ostaPek Interbody Fusion Cages system demonstrated<br>equivalent performance to the cited predicate device under the same test conditions. | | Non-clinical Test<br>Summary | The following analyses were conducted:<br>● Static and dynamic compression (ASTM F2077)<br>● Subsidence (ASTM F2267)<br>● Expulsion<br>The results of these evaluations indicate that the ostaPek Interbody Fusion Cages system<br>is equivalent to predicate devices. | | Clinical Test<br>Summary | No clinical studies were performed | | Conclusions: Non-<br>clinical and Clinical | Coligne AG considers the ostaPek Interbody Fusion Cages system to be equivalent to the<br>predicate devices listed above. This conclusion is based upon the devices' similarities in<br>principles of operation, technology, materials and indications for use. | In accordance with 21 CFR 807.92 of the Federal Code of Regulations {4}------------------------------------------------