PBI — Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive Class II
FDA product code PBI covers "Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive", a Class II medical device regulated under 21 CFR 888.3310. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- PBI
- Device Class
- Class II
- Regulation Number
- 888.3310
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
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.