KRO · Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Orthopedic · 21 CFR 888.3510 · Class 2
Overview
| Product Code | KRO |
|---|---|
| Device Name | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer |
| Regulation | 21 CFR 888.3510 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
| Implant | Yes |
Identification
A knee joint femorotibial metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits translation or rotation in one or more planes and has components that are linked together or affined. This generic type of device includes prostheses composed of a ball-and-socket joint located between a stemmed femoral and a stemmed tibial component and a runner and track joint between each pair of femoral and tibial condyles. The ball-and-socket joint is composed of a ball at the head of a column rising from the stemmed tibial component. The ball, the column, the tibial plateau, and the stem for fixation of the tibial component are made of an alloy, such as cobalt-chromium-molybdenum. The ball of the tibial component is held within the socket of the femoral component by the femoral component's flat outer surface. The flat outer surface of the tibial component abuts both a reciprocal flat surface within the cavity of the femoral component and flanges on the femoral component designed to prevent distal displacement. The stem of the femoral component is made of an alloy, such as cobalt-chromium-molybdenum, but the socket of the component is made of ultra-high molecular weight polyethylene. The femoral component has metallic runners which align with the ultra-high molecular weight polyethylene tracks that press-fit into the metallic tibial component. The generic class also includes devices whose upper and lower components are linked with a solid bolt passing through a journal bearing of greater radius, permitting some rotation in the transverse plane, a minimal arc of abduction/adduction. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).
Classification Rationale
Class II.
Recent Cleared Devices (20 of 86)
Showing 20 most recent of 86 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252898 | Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella; Triathlon® Symmetric Patella; Triathlon® Asymmetric Patella; Scorpio® Universal Dome Patella; Triathlon® Hinge Bumper | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | Dec 15, 2025 | SESE |
| K252303 | Stem Extension Line (USTAR II System) | United Orthopedic Corporation | Aug 22, 2025 | SESE |
| K251665 | Triathlon® Hinge Knee System | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | Jul 25, 2025 | SESE |
| K242871 | ATTUNE™ Revision Hinge Knee | Depuy Ireland UC | Nov 21, 2024 | SESE |
| K240043 | EVOLUTION® Hinge Knee System;GUARDIAN™ limb Salvage System;DCW Modular Distal Femoral System;REPIPHYSIS™ Limb Salvage System;EVOLUTION® MP Total Knee System; EVOLUTION® MP Total Knee System; EVOLUTION® MP Adaptive CS Insert; EVOLUTION® MP Adaptive PS Tibial Insert; EVOLUTION® MP CS/CR Porous Femur/EVOLUTION® Adaptive CS and PS Inserts; EVOLUTION® Revision CCK System; ADVANCE® Double High Insert; ADVANCE® A-CLASS® Tibial Insert; ADVANCE® Knee System; ADVANCE® Ultra-Congruent Tibial Inse | Microport Orthopedics, Inc. | Apr 1, 2024 | SESE |
| K233980 | ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Performance (HP) Partial Knee System | Depuy Ireland UC | Mar 21, 2024 | SESE |
| K230563 | EVOLUTION® Hinge Knee System | Microport Orthopedics, Inc. | Sep 27, 2023 | SESE |
| K230416 | Triathlon® Hinge Knee System; Triathlon® Revision Insert X3® | Stryker | May 19, 2023 | SESE |
| K223069 | Modular Rotating Hinge Knee Systems and Compatible Components | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | Apr 21, 2023 | SESE |
| K223528 | Triathlon® Hinge Knee System | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | Jan 20, 2023 | SESE |
| K220628 | LINK Endo-Model EVO Knee System | Waldemar Link GmbH & Co. KG | May 3, 2022 | SESE |
| K211677 | ELEOS Limb Salvage System | Onkos Surgical | Jul 28, 2021 | SESE |
| K211768 | LINK Endo-Model Knee System, Femoral Segments (Augments), UHMWPE | Waldemar Link GmbH & Co. KG | Jun 30, 2021 | SESE |
| K210010 | GMK Revision & Hinge Extension - TiNbN Coating | Medacta International S.A. | Mar 2, 2021 | SESE |
| K192798 | Zimmer Segmental System | Zimmer, Inc. | Dec 10, 2020 | SESE |
| K190181 | Instruments for LINK MEGASYSTEM-C Family | LinkBio Corp. | Oct 25, 2019 | SESE |
| K191779 | Attune Revision LPS Inserts | Depuy(Ireland) | Oct 8, 2019 | SESE |
| K190100 | USTAR II System | United Orthopedic Corporation | Sep 23, 2019 | SESE |
| K172347 | GMK Hinge, GMK Revision | Medacta International S.A. | Nov 1, 2017 | SESE |
| K163311 | GMK Revision Femoral Distal Augmentation | Medacta International S.A. | Dec 21, 2016 | SESE |
Top Applicants
- Biomet, Inc. — 9 clearances
- Howmedica Osteonics Corp. — 9 clearances
- Zimmer, Inc. — 6 clearances
- Stanmore Implants Worldwide , Ltd. — 5 clearances
- Waldemar Link GmbH & Co. KG — 5 clearances
