K121874 is an FDA 510(k) clearance for the G7 ACETABULAR SYSTEM. This device is classified as a Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer, + Additive (Class II — Special Controls, product code PBI).
Submitted by Biomet Manufacturing Corp (Warsaw, US). The FDA issued a Cleared decision on November 23, 2012, 149 days after receiving the submission on June 27, 2012.
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 | K121874 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 27, 2012 |
| Decision Date | November 23, 2012 |
| Days to Decision | 149 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. |