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 |
|---|---|---|---|
| K261009 | waldemar link gmbh and co. kg | MobileLink Acetabular Cup System 40mm ID Inserts (various) | July 6, 2026 |
| K260831 | zimmer | Z1 Hip System | June 16, 2026 |
| K260182 | zimmer | Avenir® Müller Stem; Avenir Complete Hip System | April 27, 2026 |
| K260037 | implantcast | implantcast Packaging System Update | March 30, 2026 |
| K252401 | implantcast | implaFit® short stems | March 12, 2026 |
| K253171 | maxx orthopedics | Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem) | January 15, 2026 |
| K250450 | medacta international | Coated hip implants | September 19, 2025 |
| K243021 | signature orthopaedics pty | Longboard Revision Hip Stem | August 7, 2025 |
| K251906 | zimmer | Z1 Hip System | July 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) | April 18, 2025 |
| K250571 | smith and nephew | CATALYSTEM Femoral Stems | March 28, 2025 |
| K243029 | signature orthopaedics pty | Origin TT Stem | March 11, 2025 |
| K241767 | medacta international | Versacem Acetabular Shell and Double Mobility HC Liners | March 6, 2025 |
| K243809 | limacorporate | Biolox® Delta Revision heads | March 4, 2025 |
| K241483 | encore medical l.p | ceramys femoral head system | February 7, 2025 |
| K243466 | united orthopedic corporation | Conformity Stem Extension Line, #0 | January 6, 2025 |