TRIDENT SYSTEMS
FDA premarket approval P000013/S010 · decided 2012-01-18
Approval details
- PMA number
- P000013
- Supplement
- S010
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- TRIDENT SYSTEMS
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Applicant
- Howmedica Osteonics Corp.
- Date received
- 2011-10-03
- Decision date
- 2012-01-18
- Days to decision
- 107 days
- Decision code
- APPR
- Product code
- MRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Mahwah, NJ
- Statement
- APPROVAL FOR THE ADDITION OF THE TRITANIUM PSF ACETABULAR SHELLS (SOLID-BACKED AND CLUSTER SCREW-HOLE DESIGNS) AS COMPATIBLE COMPONENTS WITH THE TRIDENT CERAMIC INSERTS, AS WELL AS MODIFICATIONS TO THE TOLERANCES AND SURFACE ROUGHNESS VALUES OF THE TAPER REGION OF ALL COMPATIBLE TRIDENT AND TRITANIUM ACETABULAR SHELLS. IN ADDITION, LABELING CHANGES WERE MADE TO ADDRESS THE COMPATIBILITY WITH THE NEW COMPONENTS.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Exeter V40 Femoral Stem, Exeter X3 RimFit Cup (K193429) | Howmedica Osteonics Corp. | 2020-08-13 |
| Triathlon Posterior Stabilized Femoral Component - beaded with Peri-Apatite, Triathlon Cruciate Retaining Femoral Component - beaded with Peri-Apatite (K200782) | Howmedica Osteonics Corp. | 2020-05-13 |
| REUNION RSA SHOULDER SYSTEM (K130895) | Howmedica Osteonics Corp. | 2013-12-27 |
| ABG III MONOLITHIC HIP STEM (K123604) | Howmedica Osteonics Corp. | 2013-08-16 |
| DISTAL FEMORAL GROWING PROSTHESIS, TIBIAL ROTATING COMPONENTS, BEARING, AXIS, CIRCLIP, WEDGE (K122015) | Howmedica Osteonics Corp. | 2013-02-22 |
| TRIATHLON ALL-POLYETHYLENE CONDYLAR STABILIZING (CS) TIBIAL IMPLANTS TRIATHLON ALL-POLYETHYLENE POSTERIOR STABILIZING (P (K123166) | Howmedica Osteonics Corp. | 2013-02-14 |
| NOVEL FIT AND FILL STEM (K122853) | Howmedica Osteonics Corp. | 2013-02-01 |
| STRYKER CMF MEDPOR CUSTOMIZED IMPLANT (K121315) | Howmedica Osteonics Corp. | 2012-11-01 |