PBI

2 FDA 510(k) clearances · Product code

FDA profile

Official device name

Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive

Device class

Class II (moderate risk)

Regulation

21 CFR 888.3310

Medical specialty

Orthopedic

Flags

Implant

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.

Adverse events (MAUDE)

2021: 133 · 2022: 128 · 2023: 255 · 2024: 255 · 2025: 237 · 2026: 104
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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