G7 Acetabular System
FDA 510(k) K121874 · Biomet Manufacturing Corp
510(k) numberK121874
Submission
- Device name
- G7 Acetabular System
- Applicant
- Biomet Manufacturing Corp
Warsaw, IN, US - Received
- June 27, 2012
- Decision date
- November 23, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PBI – Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3310
- Specialty
- Orthopedic
- Implant
- Yes
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.
Other 510(k)s with product code PBI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K212512 | G7® Vivacit-E® Freedom® Constrained LinerPBI · Traditional | Zimmer, Inc. | 04/28/2022SE |
More from Zimmer, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K230540 | Patient Specific Planning Solution 3D Bone ModelsLLZ · Traditional | 07/25/2023SE |
| K214001 | Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder SystemPHX · Traditional | 03/15/2023SE |
| K211729 | Comprehensive® Convertible Glenoid - Vivacit-E LinerPHX · Traditional | 11/04/2021SE |
| K202232 | Comprehensive Vault Reconstruction SystemPHX · Traditional | 02/19/2021SE |
| K193038 | Comprehensive Shoulder SystemMBF · Traditional | 10/28/2020SE |
| K182516 | Comprehensive Nano Stemless ShoulderPKC · Traditional | 04/22/2019SE |
| K181611 | Comprehensive Reverse Shoulder SystemPHX · Traditional | 09/24/2018SE |
| K173411 | Comprehensive Segmental Revision System (SRS)PHX · Traditional | 02/08/2018SE |
| K172502 | Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate…PHX · Traditional | 01/03/2018SE |
| K163651 | ExpressBraid Graft ManipulationGAT · Traditional | 02/17/2017SE |
Questions and answers
When was G7 Acetabular System cleared by the FDA?
G7 Acetabular System (K121874) received a 510(k) decision of Substantially Equivalent on November 23, 2012, 149 days after the submission was received.
What is the product code of K121874?
The FDA product code is PBI – Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive, a Class II (moderate risk) device regulated under 21 CFR 888.3310.