# Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive
> **Product code: OIY** · Class II — Moderate Risk (510(k) clearance required) · Orthopedic · 21 CFR 888.3560
## Classification
- **FDA Product Code:** OIY
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 888.3560
- **Review panel:** OR
- **Medical specialty:** Orthopedic
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** Y
- **Third-party review:** N
## Definition

Indicated for:  1.	Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.  2.	Correction of varus, valgus, or posttraumatic deformity.  3.	Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.    For cemented use.

## Market data
- **Cleared 510(k) submissions:** 11
- **Registered establishments:** 144
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=OIY)
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