TRILOGY AB ACETABULAR SYSTEM
FDA premarket approval P040048/S003 · decided 2008-04-11
Approval details
- PMA number
- P040048
- Supplement
- S003
- Supplement type
- 135 Review Track For 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
- 2007-11-30
- Decision date
- 2008-04-11
- Days to decision
- 133 days
- Decision code
- APPR
- Product code
- MRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Warsaw, IN
- Statement
- APPROVAL FOR A CHANGE BY THE SUPPLIER TO IMPLEMENT NEW SOFTWARE TO THE MANUFACTURING LINE TO ALLOW POLISHED INSERTS TO BE REWORKED, FOLLOWING INSPECTION, IN ONE OF THE TWO INNER SPHERE POLISHING STATIONS, WHILE THE OTHER STATION CONTINUES TO BE USED FOR INITIAL PRODUCTION.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Z1 Hip System (K260831) | Zimmer, Inc. | 2026-06-16 |
| Augment Off-Axis Instrument System (K261683) | Zimmer, Inc. | 2026-06-16 |
| Zimmer® Persona® Personalized Knee System (K251840) | Zimmer, Inc. | 2026-05-28 |
| 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 |