OSTEONICS ABC / TRIDENT SYSTEMS
FDA premarket approval P000013/S008 · decided 2007-04-26
Approval details
- PMA number
- P000013
- Supplement
- S008
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- OSTEONICS ABC / TRIDENT SYSTEMS
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Applicant
- Howmedica Osteonics Corp.
- Date received
- 2006-12-29
- Decision date
- 2007-04-26
- Days to decision
- 118 days
- Decision code
- APPR
- Product code
- MRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Mahwah, NJ
- Statement
- APPROVAL FOR A NEW LOCKING MECHANISM DESIGN FOR THE TRIDENT ACETABULAR SYSTEM (TRIDENT ALUMINA INSERTS AND TRIDENT ACETABULAR SHELLS), AS WELL AS ASSOCIATED REVISIONS TO THE PACKAGE INSERT. THIS DESIGN MODIFICATION IS INTENDED TO ALLOW FOR EASE OF INSERTION OF THE ALUMINA CERAMIC INSERT. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME TRIDENT II ACETABULAR SYSTEM (TRIDENT II ALUMINA INSERTS, TRIDENT II ACETABULAR SHELLS) AND IS INDICATED FOR PATIENTS REQUIRING PRIMARY OR REVISION
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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 |