Product code LZO
- Device name
- Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
- Medical specialty
- Orthopedic
- Device class
- 2
- Regulation number
- 888.3353
- Review panel
- OR
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260182 | Avenir® Müller Stem; Avenir Complete™ Hip System | Zimmer, Inc. | 2026-04-27 |
| K260037 | implantcast Packaging System Update | Implantcast GmbH | 2026-03-30 |
| K252401 | implaFit® short stems | Implantcast GmbH | 2026-03-12 |
| K253171 | Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem) | Maxx Orthopedics, Inc. | 2026-01-15 |
| K250450 | Coated hip implants | Medacta International S.A. | 2025-09-19 |
| K243021 | Longboard Revision Hip Stem | Signature Orthopaedics Pty, Ltd. | 2025-08-07 |
| K251906 | Z1 Hip System | Zimmer, Inc. | 2025-07-18 |
| K251292 | RECLAIM Monobloc Revision Femoral Stem | Depuy Ireland UC | 2025-05-23 |
| K243927 | MobileLink Acetabular Cup System - inhouse coatings | Waldemar Link GmbH & Co. KG | 2025-05-16 |
| K250444 | NEXUS® Hip Stem | Microport Orthopedics, Inc. | 2025-05-15 |
| K243043 | Origin™ Cemented Hip Stem | Signature Orthopaedics Pty, Ltd. | 2025-05-02 |
| K250834 | Zimmer Biomet Ceramic Heads (22.2mm diameter) | Zimmer Biomet | 2025-04-18 |
| K250571 | CATALYSTEM Femoral Stems | Smith & Nephew, Inc. | 2025-03-28 |
| K243029 | Origin™ TT Stem | Signature Orthopaedics Pty, Ltd. | 2025-03-11 |
| K241767 | Versacem Acetabular Shell and Double Mobility HC Liners | Medacta International S.A. | 2025-03-06 |
| K243809 | Biolox® Delta Revision heads | Limacorporate | 2025-03-04 |
| K241483 | ceramys™ femoral head system | Encore Medical L.P. | 2025-02-07 |
| K243466 | Conformity Stem Extension Line, #0 | United Orthopedic Corporation | 2025-01-06 |
| K243444 | BIOCERAM AZUL® HEAD | Kyocera Corporation | 2024-12-05 |
| K240528 | b-ONE® Total Hip System | B-One Ortho, Corp. | 2024-11-15 |
| K240391 | MUTARS® femoral stem cemented 160 mm and 200 mm | Implantcast GmbH | 2024-10-24 |
| K242249 | Conformity Stem Extension Line | United Orthopedic Corporation | 2024-08-30 |
| K241241 | Z1 Cemented Hip System | Orchard Medical Development, LLC | 2024-08-27 |
| K240381 | CATALYSTEM Femoral Stems | Smith & Nephew, Inc. | 2024-06-27 |
| K240834 | EcoFit® short stem cementless cpTi | Implantcast GmbH | 2024-06-03 |
| K234025 | 22.2mm BIOLOX® delta Ceramic V40™ Femoral Heads | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2024-04-24 |
| K240452 | Ceramic Femoral Head | Microport Orthopedics, Inc. | 2024-04-12 |
| K233724 | 28mm/38D MDM X3 Insert for MDM Liner | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2024-03-11 |
| K233476 | Z1 Hip System | Orchard Medical Development | 2024-02-08 |
| K223745 | Novae® Dual Mobility System, Hype® Hip System | Serf | 2023-12-22 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07630542788321 | AMIStem-P | Medacta International SA | 2026-06-08 |
| 07630542788338 | AMIStem-P | Medacta International SA | 2026-06-08 |
| 07630542788345 | AMIStem-P | Medacta International SA | 2026-06-08 |
| 07630542788352 | AMIStem-P | Medacta International SA | 2026-06-08 |
| 07630542788369 | AMIStem-P | Medacta International SA | 2026-06-08 |
| 07630542788376 | AMIStem-P | Medacta International SA | 2026-06-08 |
| 07630542788314 | AMIStem-P | Medacta International SA | 2026-06-08 |
| 00810030812098 | InSitu Hip System | NEXTSTEP ARTHROPEDIX, LLC | 2026-06-01 |
| 00810030812081 | InSitu Hip System | NEXTSTEP ARTHROPEDIX, LLC | 2026-06-01 |
| 00810030812074 | InSitu Hip System | NEXTSTEP ARTHROPEDIX, LLC | 2026-06-01 |
| 00810030812067 | InSitu Hip System | NEXTSTEP ARTHROPEDIX, LLC | 2026-06-01 |
| 00810030812050 | InSitu Hip System | NEXTSTEP ARTHROPEDIX, LLC | 2026-06-01 |
| 00810030812043 | InSitu Hip System | NEXTSTEP ARTHROPEDIX, LLC | 2026-06-01 |
| 00810030812036 | InSitu Hip System | NEXTSTEP ARTHROPEDIX, LLC | 2026-06-01 |
| 00810030811992 | InSitu Hip System | NEXTSTEP ARTHROPEDIX, LLC | 2026-06-01 |
| 00885556321942 | REDAPT | Smith & Nephew, Inc. | 2016-02-24 |
| 00885556321843 | REDAPT | Smith & Nephew, Inc. | 2015-12-11 |
| 00885556321744 | REDAPT | Smith & Nephew, Inc. | 2015-12-11 |
| 00885556321690 | REDAPT | Smith & Nephew, Inc. | 2015-12-11 |
| 00885556321591 | REDAPT | Smith & Nephew, Inc. | 2015-12-11 |
| 00885556321492 | REDAPT | Smith & Nephew, Inc. | 2015-12-11 |
| 00885556321393 | REDAPT | Smith & Nephew, Inc. | 2015-12-11 |
| 03596010474162 | OXINIUM | Smith & Nephew, Inc. | 2015-08-30 |
| 03596010474179 | OXINIUM | Smith & Nephew, Inc. | 2015-08-30 |
| 03596010474209 | OXINIUM | Smith & Nephew, Inc. | 2015-08-30 |
| 03596010474216 | OXINIUM | Smith & Nephew, Inc. | 2015-08-30 |
| 03596010474223 | OXINIUM | Smith & Nephew, Inc. | 2015-08-30 |
| 03596010474230 | OXINIUM | Smith & Nephew, Inc. | 2015-08-30 |
| 03596010488862 | OXINIUM | Smith & Nephew, Inc. | 2015-08-30 |
| 03596010474148 | OXINIUM | Smith & Nephew, Inc. | 2015-08-30 |