LZO — Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Class II
FDA product code LZO covers "Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented", a Class II medical device regulated under 21 CFR 888.3353. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LZO
- Device Class
- Class II
- Regulation Number
- 888.3353
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K260173 | Medacta International | M-Vizion Femoral Revision System Extension | Sep 17, 2026 |
| K253948 | United Orthopedic Corporation | Momentum Acetabular Cup System | Sep 2, 2026 |
| K261009 | Waldemar Link Gmbh And Co. Kg | MobileLink Acetabular Cup System 40mm ID Inserts (various) | Jul 6, 2026 |
| K260831 | Zimmer | Z1 Hip System | Jun 16, 2026 |
| K260182 | Zimmer | Avenir® Müller Stem; Avenir Complete Hip System | Apr 27, 2026 |
| K260037 | Implantcast | implantcast Packaging System Update | Mar 30, 2026 |
| K252401 | Implantcast | implaFit® short stems | Mar 12, 2026 |
| K253171 | Maxx Orthopedics | Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem) | Jan 15, 2026 |
| K250450 | Medacta International | Coated hip implants | Sep 19, 2025 |
| K243021 | Signature Orthopaedics Pty | Longboard Revision Hip Stem | Aug 7, 2025 |
| K251906 | Zimmer | Z1 Hip System | Jul 18, 2025 |
| K251292 | Depuy Ireland Uc | RECLAIM Monobloc Revision Femoral Stem | May 23, 2025 |
| K243927 | Waldemar Link Gmbh And Co. Kg | MobileLink Acetabular Cup System - inhouse coatings | May 16, 2025 |
| K250444 | Microport Orthopedics | NEXUS® Hip Stem | May 15, 2025 |
| K243043 | Signature Orthopaedics Pty | Origin Cemented Hip Stem | May 2, 2025 |
| K250834 | Zimmer Biomet | Zimmer Biomet Ceramic Heads (22.2mm diameter) | Apr 18, 2025 |
| K250571 | Smith And Nephew | CATALYSTEM Femoral Stems | Mar 28, 2025 |
| K243029 | Signature Orthopaedics Pty | Origin TT Stem | Mar 11, 2025 |
| K241767 | Medacta International | Versacem Acetabular Shell and Double Mobility HC Liners | Mar 6, 2025 |
| K243809 | Limacorporate | Biolox® Delta Revision heads | Mar 4, 2025 |