510(k) K121874
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 23, 2012
- Date Received
- June 27, 2012
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive
- Device Class
- Class II
- Regulation Number
- 888.3310
- Review Panel
- OR
- Submission Type
For use as a component of a total hip prosthesis in primary and revision patients at high risk of dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability, and for whom all other options to constrained acetabular components have been considered.