Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive
PBI is the FDA product code for Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive, a class II device type, regulated under 21 CFR 888.3310. FDA's definition for this code reads: "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...". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and 2 recalls.
Classification record
- Product code
- PBI
- Device name
- Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive
- FDA 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.
- Regulation
- 21 CFR 888.3310
- Device class
- Class II
- Review panel
- Orthopedic
- Submission type
- 510(k)
- Implant
- Yes
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 2
- Ingested recalls
- 2
Clearances, product code PBI
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2012 | 1 |
| 2022 | 1 |
Applicants with the most clearances
Product code PBI| Applicant | Clearances |
|---|---|
| Biomet Manufacturing Corp | 1 |
| Zimmer GmbH | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
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