# Metal Cemented Constrained Femorotibial Knee Prosthesis
> **Product code: KRN** · Class III — High Risk (PMA approval required, life-sustaining) · Orthopedic · 21 CFR 888.3480
## Classification
- **FDA Product Code:** KRN
- **Device class:** Class III — High Risk (PMA approval required, life-sustaining)
- **Regulation:** 21 CFR 888.3480
- **Review panel:** OR
- **Medical specialty:** Orthopedic
- **Submission type:** 2
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** Y
- **Third-party review:** N
## Definition

Call for pmas 12/26/96 ( 61 fr 50710 9/27/96)

## 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=KRN)
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