PBI — Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive Class II
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.