LZO · Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Orthopedic · 21 CFR 888.3353 · Class 2
Overview
| Product Code | LZO |
|---|---|
| Device Name | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented |
| Regulation | 21 CFR 888.3353 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
| Implant | Yes |
Identification
A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 529)
Showing 20 most recent of 529 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K260037 | implantcast Packaging System Update | Implantcast GmbH | Mar 30, 2026 | SESE |
| K252401 | implaFit® short stems | Implantcast GmbH | Mar 12, 2026 | SESE |
| K253171 | Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem) | Maxx Orthopedics, Inc. | Jan 15, 2026 | SESE |
| K250450 | Coated hip implants | Medacta International S.A. | Sep 19, 2025 | SESE |
| K243021 | Longboard Revision Hip Stem | Signature Orthopaedics Pty, Ltd. | Aug 7, 2025 | SESE |
| K251906 | Z1 Hip System | Zimmer, Inc. | Jul 18, 2025 | SESE |
| K251292 | RECLAIM Monobloc Revision Femoral Stem | Depuy Ireland UC | May 23, 2025 | SESE |
| K243927 | MobileLink Acetabular Cup System - inhouse coatings | Waldemar Link GmbH & Co. KG | May 16, 2025 | SESE |
| K250444 | NEXUS® Hip Stem | Microport Orthopedics, Inc. | May 15, 2025 | SESE |
| K243043 | Origin Cemented Hip Stem | Signature Orthopaedics Pty, Ltd. | May 2, 2025 | SESE |
| K250834 | Zimmer Biomet Ceramic Heads (22.2mm diameter) | Zimmer Biomet | Apr 18, 2025 | SESE |
| K250571 | CATALYSTEM Femoral Stems | Smith & Nephew, Inc. | Mar 28, 2025 | SESE |
| K243029 | Origin TT Stem | Signature Orthopaedics Pty, Ltd. | Mar 11, 2025 | SESE |
| K241767 | Versacem Acetabular Shell and Double Mobility HC Liners | Medacta International S.A. | Mar 6, 2025 | SESE |
| K243809 | Biolox® Delta Revision heads | Limacorporate | Mar 4, 2025 | SESE |
| K241483 | ceramys femoral head system | Encore Medical L.P. | Feb 7, 2025 | SESE |
| K243466 | Conformity Stem Extension Line, #0 | United Orthopedic Corporation | Jan 6, 2025 | SESE |
| K243444 | BIOCERAM AZUL® HEAD | Kyocera Corporation | Dec 5, 2024 | SESE |
| K240528 | b-ONE® Total Hip System | B-One Ortho, Corp. | Nov 15, 2024 | SESE |
| K240391 | MUTARS® femoral stem cemented 160 mm and 200 mm | Implantcast GmbH | Oct 24, 2024 | SESE |
Top Applicants
- Medacta International S.A. — 27 clearances
- Smith & Nephew, Inc. — 24 clearances
- Howmedica Osteonics Corp. — 23 clearances
- Biomet, Inc. — 21 clearances
- Exactech, Inc. — 21 clearances
