G7® Vivacit-E® Freedom® Constrained Liner
FDA 510(k) K212512 · Zimmer, Inc.
510(k) numberK212512
Submission
- Device name
- G7® Vivacit-E® Freedom® Constrained Liner
- Applicant
- Zimmer, Inc.
Warsaw, IN, US - Received
- August 10, 2021
- Decision date
- April 28, 2022
- 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 |
|---|---|---|---|
| K121874 | G7 Acetabular SystemPBI · Traditional | Biomet Manufacturing Corp | 11/23/2012SE |
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Questions and answers
When was G7® Vivacit-E® Freedom® Constrained Liner cleared by the FDA?
G7® Vivacit-E® Freedom® Constrained Liner (K212512) received a 510(k) decision of Substantially Equivalent on April 28, 2022, 261 days after the submission was received.
What is the product code of K212512?
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.