TRILOGY AB ACETABULAR SYSTEM
FDA premarket approval P040048/S010 · decided 2009-12-08
Approval details
- PMA number
- P040048
- Supplement
- S010
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TRILOGY AB ACETABULAR SYSTEM
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Applicant
- Zimmer, Inc.
- Date received
- 2009-11-09
- Decision date
- 2009-12-08
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- MRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Warsaw, IN
- Statement
- CHANGE TO MANUFACTURING STEPS AND MATERIALS USED DURING THE MANUFACTURE OF THE VERSYS HERITAGE FEMORAL STEMS.
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510(k) clearances by this applicant
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|---|---|---|
| Z1 Hip System (K260831) | Zimmer, Inc. | 2026-06-16 |
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| Avenir® Müller Stem; Avenir Complete™ Hip System (K260182) | Zimmer, Inc. | 2026-04-27 |
| Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter) (K253592) | Zimmer, Inc. | 2026-04-13 |
| Affixus Retrograde Femoral Nailing System (K253566) | Zimmer, Inc. | 2026-03-12 |
| Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs) (K253189) | Zimmer, Inc. | 2026-03-09 |
| G7® Revision Acetabular System (K252623) | Zimmer, Inc. | 2026-02-04 |