510(k) K212512
K212512 is an FDA 510(k) premarket notification submitted by Zimmer, Inc. for the device "G7® Vivacit-E® Freedom® Constrained Liner". The FDA issued a decision of Substantially Equivalent on Apr 28, 2022. 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. Zimmer, Inc. has 421 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 28, 2022
- Date Received
- Aug 10, 2021
- 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
- 510(k)
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.