OSTEONICS ABC/TRIDENT SYSTEMS
FDA premarket approval P000013/S001 · decided 2003-03-17
Approval details
- PMA number
- P000013
- Supplement
- S001
- 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
- 2003-02-04
- Decision date
- 2003-03-17
- Days to decision
- 41 days
- Decision code
- APPR
- Product code
- MRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Mahwah, NJ
- Statement
- APPROVAL FOR THE FOLLOWING ITEMS: 1) USE OF THE TRIDENT ACETABULAR SYSTEM WITH V40 ALUMINA HEADS AND ADDITIONAL C-TAPER ALUMINA HEAD SIZES (AND ASSOCIATED STEMS) 2) USE OF THE TRIDENT ACETABULAR SYSTEM WITH V40/C-TAPER AND MORSE TAPER ADAPTER SLEEVES (AND ASSOCIATED FEMORAL STEMS) 3) USE OF ADDITIONAL STYLES OF TRIDENT ACETABULAR SHELLS; AND 4) ASSOCIATED LABELING CHANGES DUE TO MODIFICATIONS IDENTIFIED ABOVE.
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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 |