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 |
|---|---|---|---|
| K262473 | NEXUS® Hip Stem | Microport Orthopedics, Inc. | 2026-10-01 |
| K260173 | M-Vizion Femoral Revision System Extension | Medacta International S.A. | 2026-09-17 |
| 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 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07613327020939 | Secur-Fit | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327021073 | Secur-Fit | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327021066 | Secur-Fit | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327021059 | Secur-Fit | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327021042 | Secur-Fit | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327021035 | Secur-Fit | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327021028 | Secur-Fit | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327021011 | Secur-Fit | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327021004 | Secur-Fit | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327020991 | Secur-Fit | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327020984 | Secur-Fit | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327020977 | Secur-Fit | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327020960 | Secur-Fit | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327020953 | Secur-Fit | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327020946 | Secur-Fit | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327020786 | Secur-Fit | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327020922 | Secur-Fit | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327020915 | Secur-Fit | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327020908 | Secur-Fit | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327020892 | Secur-Fit | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327020885 | Secur-Fit | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327020878 | Secur-Fit | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327020861 | Secur-Fit | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327020854 | Secur-Fit | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327020847 | Secur-Fit | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327020830 | Secur-Fit | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327020823 | Secur-Fit | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327020816 | Secur-Fit | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327020809 | Secur-Fit | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327020793 | Secur-Fit | Howmedica Osteonics Corp. | 2015-09-24 |