# Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
> **Product code: KRO** · Class II — Moderate Risk (510(k) clearance required) · Orthopedic · 21 CFR 888.3510
## Classification
- **FDA Product Code:** KRO
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 888.3510
- **Review panel:** OR
- **Medical specialty:** Orthopedic
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** Y
- **Third-party review:** N
## Market data
- **Cleared 510(k) submissions:** 86
- **Registered establishments:** 136
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=KRO)
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