# Prosthesis, Hip, Pelvifemoral Resurfacing,  Metal/Polymer
> **Product code: KXB** · Class III — High Risk (PMA approval required, life-sustaining) · Orthopedic · 21 CFR 888.3410
## Classification
- **FDA Product Code:** KXB
- **Device class:** Class III — High Risk (PMA approval required, life-sustaining)
- **Regulation:** 21 CFR 888.3410
- **Review panel:** OR
- **Medical specialty:** Orthopedic
- **Submission type:** 2
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** Y
- **Third-party review:** N
## Definition

Pma to be filed by 1/3/05 (69 fr 59134 (10/4/04)) for any hip joint metal/polymer or ceramic/polymer semiconstrained resurfacing cemented prosthesis that was in commercial distribution before may 28, 1976, or that has, on or before january 3, 2005, been found to be substantially equivalent to a hip joint metal/polymer or ceramic/polymer semiconstrained resurfacing cemented prosthesis that was in commercial distribution before may 28, 1976. Any other hip joint metal/polymer or ceramic/polymer semiconstrained resurfacing cemented prosthesis must have an approved pma or a declared completed pdp in effect before being placed in commercial distribution.

## Market data
- **Cleared 510(k) submissions:** 0
- **Registered establishments:** 0
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=KXB)
---
*AI Analytics · CC0 1.0*