510(k) K121874
K121874 is an FDA 510(k) premarket notification submitted by Biomet Manufacturing Corp for the device "G7 ACETABULAR SYSTEM". The FDA issued a decision of Substantially Equivalent on November 23, 2012. The device falls under product code PBI (Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive), a Class II device regulated under 21 CFR 888.3310. Biomet Manufacturing Corp has at least 10 other 510(k) clearances on record.
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.