S-ROM POLY-DIAL CONSTRAINED ACETABULAR LINER
FDA premarket approval P960054/S002 · decided 1999-12-07
Approval details
- PMA number
- P960054
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- S-ROM POLY-DIAL CONSTRAINED ACETABULAR LINER
- Generic name
- Prosthesis, hip, constrained, cemented or uncemented, metal/polymer
- Applicant
- Depuy, A Johnson & Johnson Co.
- Date received
- 1999-07-30
- Decision date
- 1999-12-07
- Days to decision
- 130 days
- Decision code
- APPR
- Product code
- KWZ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Warsaw, IN
- Statement
- Approval for a design modification made to the S-ROM constrained liner so to be used withthe DePuy Duraloc and Solution Acetabular Cup Systems. This device is indicated for use as a component of a total hip prosthesis in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease or intraoperative instability.
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