# Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive
> **Product code: PBI** · Class II — Moderate Risk (510(k) clearance required) · Orthopedic · 21 CFR 888.3310
## Classification
- **FDA Product Code:** PBI
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 888.3310
- **Review panel:** OR
- **Medical specialty:** Orthopedic
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** Y
- **Third-party review:** N
## 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.

## Market data
- **Cleared 510(k) submissions:** 2
- **Registered establishments:** 31
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=PBI)
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