JDI · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Orthopedic · 21 CFR 888.3350 · Class 2
Overview
| Product Code | JDI |
|---|---|
| Device Name | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented |
| Regulation | 21 CFR 888.3350 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
| Implant | Yes |
Identification
A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip 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 an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).
Classification Rationale
Class II.
Recent Cleared Devices (20 of 562)
Showing 20 most recent of 562 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K243571 | Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners | Zimmer Biomet | Jul 31, 2025 | SESE |
| K240783 | Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip Stems | Smith & Nephew, Inc. | Oct 21, 2024 | SESE |
| K241716 | Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Component | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | Aug 2, 2024 | SESE |
| K240418 | Stryker Orthopaedics Hip Systems Labeling Update | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | Apr 12, 2024 | SESE |
| K233261 | Global Modular Replacement System | Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics | Dec 8, 2023 | SESE |
| K222056 | Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | Jan 26, 2023 | SESE |
| K220216 | C-Stem AMT LE Prosthesis | Depuy Ireland UC | Jul 22, 2022 | SESE |
| K213701 | Exeter® X3® RimFit® Cup | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | Feb 1, 2022 | SESE |
| K213816 | MPO Hip Instruments | Microport Orthopedics, Inc. | Jan 5, 2022 | SESE |
| K210842 | VerSys Cemented Revision/Calcar | Zimmer, Inc. | Dec 10, 2021 | SESE |
| K203815 | ELEOS Limb Salvage System with BioGrip | Onkos Surgical | Jun 9, 2021 | SESE |
| K203588 | ELEOS Limb Salvage System | Onkos Surgical | Feb 5, 2021 | SESE |
| K203090 | ELEOS Limb Salvage System featuring BIOGRIP | Onkos Surgical | Dec 11, 2020 | SESE |
| K201519 | PROFEMUR® GLADIATOR® Cemented Classic Stem | Microport Orthopedics, Inc. | Dec 10, 2020 | SESE |
| K193429 | Exeter V40 Femoral Stem, Exeter X3 RimFit Cup | Howmedica Osteonics Corp. | Aug 13, 2020 | SESE |
| K191449 | ZCA All-Poly Acetabular Cups | Zimmer, Inc. | Jul 16, 2020 | SESE |
| K200823 | Zimmer, Inc. Hip Joint Prostheses MR Labeling I | Zimmer, Inc. | Jul 9, 2020 | SESE |
| K191735 | CPT Hip System | Zimmer, Inc. | Mar 20, 2020 | SESE |
| K191056 | Conformity stem, cemented | United Orthopedic Corporation | Jan 3, 2020 | SESE |
| K191414 | EXETER Centralizer, EXETER 2.5mm Plug | Stryker Orthopaedics | Aug 28, 2019 | SESE |
Top Applicants
- Biomet, Inc. — 50 clearances
- Depuy, Inc. — 45 clearances
- Howmedica Corp. — 35 clearances
- Osteonics Corp. — 29 clearances
- Zimmer, Inc. — 27 clearances
