K212512 is an FDA 510(k) clearance for the G7® Vivacit-E® Freedom® Constrained Liner. This device is classified as a Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer, + Additive (Class II - Special Controls, product code PBI).
Submitted by Zimmer, Inc. (Warsaw, US). The FDA issued a Cleared decision on April 28, 2022, 261 days after receiving the submission on August 10, 2021.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3310. 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..
| 510(k) Number | K212512 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 10, 2021 |
| Decision Date | April 28, 2022 |
| Days to Decision | 261 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | PBI — Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer, + Additive |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3310 |
| Definition | 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. |