← Product Code [JWH](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH) · K062037 # TRIATHLON LOW PROFILE TIBIAL TRAY (K062037) _Howmedica Osteonics Corp. · JWH · Aug 3, 2006 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH/K062037 ## Device Facts - **Applicant:** Howmedica Osteonics Corp. - **Product Code:** [JWH](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH.md) - **Decision Date:** Aug 3, 2006 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 888.3560 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The Triathlon® Low Profile Tibial Tray is intended to be used with commercially available Triathlon® femoral components and associated patellar components, and tibial bearing inserts in primary cemented total knee arthroplasty. ## Device Story Triathlon® Low Profile Tibial Tray is a sterile, single-use orthopedic implant component for total knee arthroplasty (TKA). It functions as a tibial tray in a cemented knee prosthesis system. Used by orthopedic surgeons in clinical settings to replace diseased or damaged knee joint surfaces. The device provides a stable base for tibial bearing inserts and femoral components, restoring joint configuration and function. It benefits patients by alleviating pain and improving mobility in cases of degenerative, rheumatoid, or post-traumatic arthritis. The device is a line extension of the existing Triathlon® Primary System. ## Clinical Evidence Bench testing only. No clinical data presented. ## Technological Characteristics Tibial tray knee component; metal/polymer construction; semi-constrained cemented prosthesis. Designed for use in total knee arthroplasty. Sterile, single-use device. ## Regulatory Identification A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027). ## Predicate Devices - Triathlon® Posterior Stabilizing (PS) Total Knee System - Triathlon® Cruciate Retaining (CR) Total Knee System - Scorpio® Low Profile Tibial Tray ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ AUG 0 3 2006 K06-2037 Page 1 of 2 ## Summary of Safety and Effectiveness Triathlon® Low Profile Tibial Tray | Proprietary Name: | Triathlon® Low Profile Tibial Tray | | |-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | Common Name: | Tibial Tray Knee Component | | | Classification Name and Reference | Knee Joint Patellofemorotibial
Polymer/Metal/Polymer Semi-Constrained
Cemented Prosthesis, 21 CFR §888.3560 | | | Device Product Code: | 87 JWH | | | For Information Contact: | Francisco Haro, Regulatory Affairs Specialist
Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah, NJ 07430
Phone: (201) 831-5493
Fax: (201) 831-6038 | | | Date Summary Prepared: | July 14, 2006 | | Date Summary Prepared: Description: This Special 510(k) submission is a line extension intended to add a low profile tibial tray to the Triathlon® Primary System. ## Intended Use: The modifications do not alter the intended use of the predicate system as cleared in the referenced premarket notifications. The subject and predicate devices are sterile, single use tibial tray knee components intended to be used in total knee arthroplasty (TKA). The indications for use for the Triathlon® Low Profile Tibial Tray are provided below. ## Indications for Use: - Painful, disabling joint disease of the knee resulting from: degenerative . arthritis, rheumatoid arthritis or post-traumatic arthritis. - . Post-traumatic loss of knee joint configuration and function. - . Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability. б {1}------------------------------------------------ 06-2037 Page 2 of 2 ## Substantial Equivalence: The subject Triathlon® Low Profile Tibial Tray shares the same intended use, and basic design concepts as that of the currently available tibial trays of the Triathlon® Posterior Stabilizing (PS) Total Knee System, Triathlon® Cruciate Retaining (CR) Total Knee System, and Scorpio® Low Profile Tibial Tray. Mechanical testing demonstrated comparable mechanical properties to the predicate components and substantial equivalence to these devices. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The caduceus is a symbol of medicine and healing. The logo also includes the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" arranged in a circular pattern around the caduceus symbol. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 AUG () 3 2006 Howmedica Osteonics Corp. % Mr. Francisco Haro Regulatory Affairs Specialist 325 Corporate Drive Mahwah. New Jersey 07430 Re: K062037 Trade/Device Name: Triathlon® Low Profile Tibial Tray Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH Dated: July 14, 2006 Ta 1 X Received: July 19, 2006 Dear Mr. Haro: 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. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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. {3}------------------------------------------------ Page 2 - Mr. Francisco Haro This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely vours. Hulud Lemmeruo Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ 510(k) Number (if known): Device Name: Triathlon® Low Profile Tibial Tray The Triathlon® Low Profile Tibial Tray is intended to be used with commercially available Triathlon® femoral components and associated patellar components, and tibial bearing inserts in primary cemented total knee arthroplasty. The indications/contraindications for the Triathlon® Low Profile Tibial Tray are outlined below: Indications for Use: - · Painful, disabling joint disease of the knee resulting from: degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis. - · Post-traumatic loss of knee joint configuration and function. - · Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability. Contraindications: - Any active or suspected latent infection in or about the knee joint. . - Any mental or neuromuscular disorder which would create an unacceptable risk of . prosthesis instability, prosthesis fixation failure, or complications in postoperative care. - Bone stock compromised by disease, infection or prior implantation which cannot . provide adequate support and/or fixation to the prosthesis. - Skeletal immaturity. � - Severe instability of the knee joint secondary to the absence of collateral ligament ● integrity and function. - Obesity. An overweight or obese patient can produce loads on the prosthesis which can . lead to failure of the fixation of the device or to failure of the device itself. - The use of bone augmentations is contraindicated with the low profile tibial trays. ● | Prescription Use
(Part 21 CFR 801 Subpart D) | X | |-------------------------------------------------|---| | Over-The-Counter Use
(21 CFR 807 Subpart C) | | (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) ![Signature](signature.png) Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of General, Restorative, and Neurological Devices 39 K062037 510(k) Number. --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH/K062037](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH/K062037) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com