LZO
- Product code
- LZO
- Device name
- Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
- Device class
- Class 2
- 21 CFR
- 21 CFR 888.3353
- Medical specialty
- Orthopedic
- Marketing pathway
- 510(K)
- Flag
- Implant
- 510(k) clearances (last 3 years)
- 532
510(k) clearances, last 3 years (34)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K261009 | 2026-07-06 | Waldemar Link GmbH & Co. KG | MobileLink Acetabular Cup System 40mm ID Inserts ( | |
| K260831 | 2026-06-16 | Zimmer, Inc. | Z1 Hip System | |
| K260182 | 2026-04-27 | Zimmer, Inc. | Avenir® Müller Stem; Avenir Complete Hip System | |
| K260037 | 2026-03-30 | Implantcast GmbH | implantcast Packaging System Update | |
| K252401 | 2026-03-12 | Implantcast GmbH | implaFit® short stems | |
| K253171 | 2026-01-15 | Maxx Orthopedics, Inc. | Libertas Taper Short (TS) Uncemented Femoral Stem (L | |
| K250450 | 2025-09-19 | Medacta International S.A. | Coated hip implants | |
| K243021 | 2025-08-07 | Signature Orthopaedics Pty, Ltd. | Longboard Revision Hip Stem | |
| K251906 | 2025-07-18 | Zimmer, Inc. | Z1 Hip System | |
| K251292 | 2025-05-23 | Depuy Ireland UC | RECLAIM Monobloc Revision Femoral Stem | |
| K243927 | 2025-05-16 | Waldemar Link GmbH & Co. KG | MobileLink Acetabular Cup System - inhouse coatings | |
| K250444 | 2025-05-15 | Microport Orthopedics, Inc. | NEXUS® Hip Stem | |
| K243043 | 2025-05-02 | Signature Orthopaedics Pty, Ltd. | Origin Cemented Hip Stem | |
| K250834 | 2025-04-18 | Zimmer Biomet | Zimmer Biomet Ceramic Heads (22.2mm diameter) | |
| K250571 | 2025-03-28 | Smith & Nephew, Inc. | CATALYSTEM Femoral Stems | |
| K243029 | 2025-03-11 | Signature Orthopaedics Pty, Ltd. | Origin TT Stem | |
| K241767 | 2025-03-06 | Medacta International S.A. | Versacem Acetabular Shell and Double Mobility HC Lin | |
| K243809 | 2025-03-04 | Limacorporate | Biolox® Delta Revision heads | FDA |
| K241483 | 2025-02-07 | Encore Medical L.P. | ceramys femoral head system | |
| K243466 | 2025-01-06 | United Orthopedic Corporation | Conformity Stem Extension Line, #0 | |
| K243444 | 2024-12-05 | Kyocera Corporation | BIOCERAM AZUL® HEAD | |
| K240528 | 2024-11-15 | B-One Ortho, Corp. | b-ONE® Total Hip System | |
| K240391 | 2024-10-24 | Implantcast GmbH | MUTARS® femoral stem cemented 160 mm and 200 mm | FDA |
| K242249 | 2024-08-30 | United Orthopedic Corporation | Conformity Stem Extension Line | FDA |
| K241241 | 2024-08-27 | Orchard Medical Development, LLC | Z1 Cemented Hip System | |
| K240381 | 2024-06-27 | Smith & Nephew, Inc. | CATALYSTEM Femoral Stems | FDA |
| K240834 | 2024-06-03 | Implantcast GmbH | EcoFit® short stem cementless cpTi | |
| K234025 | 2024-04-24 | Howmedica Osteonics Corp., Dba Stryker | 22.2mm BIOLOX® delta Ceramic V40 Femoral Heads | |
| K240452 | 2024-04-12 | Microport Orthopedics, Inc. | Ceramic Femoral Head | |
| K233724 | 2024-03-11 | Howmedica Osteonics Corp., Dba Stryker | 28mm/38D MDM X3 Insert for MDM Liner | FDA |
| K233476 | 2024-02-08 | Orchard Medical Development | Z1 Hip System | FDA |
| K223745 | 2023-12-22 | Serf | Novae® Dual Mobility System, Hype® Hip System | |
| K232371 | 2023-10-19 | Implantcast GmbH | Actinia® hip stems | |
| K233233 | 2023-10-11 | Depuy Ireland UC | EMPHASYS Femoral Stems |
Official FDA classification page: LZO
Classification and pathway per current FDA publications. Data from openFDA (CC0).