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 |
|---|---|---|---|
| K253948 | Momentum Acetabular Cup System | United Orthopedic Corporation | 2026-09-02 |
| K261009 | MobileLink Acetabular Cup System – 40mm ID Inserts (various) | Waldemar Link GmbH & Co. KG | 2026-07-06 |
| K260831 | Z1 Hip System | Zimmer, Inc. | 2026-06-16 |
| 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 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 05056139247293 | Icona Hip Stem | CORIN LTD | 2025-04-07 |
| 10885862010889 | NA | Exactech, Inc. | 2022-08-18 |
| 10885862016782 | AcuMatch | Exactech, Inc. | 2022-08-18 |
| 10885862016775 | AcuMatch | Exactech, Inc. | 2022-08-18 |
| 10885862016768 | AcuMatch | Exactech, Inc. | 2022-08-18 |
| 10885862016751 | NA | Exactech, Inc. | 2022-08-18 |
| 10885862016744 | NA | Exactech, Inc. | 2022-08-18 |
| 10885862016737 | NA | Exactech, Inc. | 2022-08-18 |
| 10885862016720 | NA | Exactech, Inc. | 2022-08-18 |
| 10885862016713 | NA | Exactech, Inc. | 2022-08-18 |
| 10885862016706 | NA | Exactech, Inc. | 2022-08-18 |
| 10885862016690 | NA | Exactech, Inc. | 2022-08-18 |
| 10885862010896 | NA | Exactech, Inc. | 2022-08-18 |
| 10885862010872 | NA | Exactech, Inc. | 2022-08-18 |
| 10885862010506 | NA | Exactech, Inc. | 2022-07-28 |
| 10885862012449 | NA | Exactech, Inc. | 2022-07-28 |
| 10885862012456 | NA | Exactech, Inc. | 2022-07-28 |
| 10885862013767 | NA | Exactech, Inc. | 2022-07-28 |
| 09351327000084 | Optimized Positioning System (OPS) Femoral | OPTIMIZED ORTHO PTY LTD | 2019-04-18 |
| 09351327000060 | Optimiized Positioning System(OPS) and Optimized Postioning System(OPS)Femoral | OPTIMIZED ORTHO PTY LTD | 2019-04-18 |
| 09351327000053 | Optimized Positioning System (OPS) and Optimized Postioning System (OPS) Femoral | OPTIMIZED ORTHO PTY LTD | 2019-04-18 |
| 09351327000022 | Optimized Positioning System (OPS) | OPTIMIZED ORTHO PTY LTD | 2019-04-18 |
| 09351327000046 | Optimized Ortho Positioning (OPS) Femoral | OPTIMIZED ORTHO PTY LTD | 2019-04-12 |
| 09351327000039 | Optimized Ortho Positioning (OPS) Femoral | OPTIMIZED ORTHO PTY LTD | 2019-04-12 |
| 09351327000015 | Optimized Ortho Positioning (OPS) System | OPTIMIZED ORTHO PTY LTD | 2019-04-12 |
| 09351327000008 | Optimized Ortho Positioning (OPS) System | OPTIMIZED ORTHO PTY LTD | 2019-04-12 |
| 00880304539259 | Arcos® Modular Revision Hip System | Biomet Orthopedics, LLC | 2015-10-24 |
| 00880304474246 | Arcos® Modular Revision Hip System | Biomet Orthopedics, LLC | 2015-10-24 |
| 00880304474185 | Arcos® Modular Revision Hip System | Biomet Orthopedics, LLC | 2015-10-24 |
| 10885862032102 | Novation | Exactech, Inc. | 2015-08-10 |