# Ankle Arthroplasty Implantation System
> **Product code: OYK** · Class II — Moderate Risk (510(k) clearance required) · Orthopedic · 21 CFR 888.3110
## Classification
- **FDA Product Code:** OYK
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 888.3110
- **Review panel:** OR
- **Medical specialty:** Orthopedic
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## Definition

Intended to be used to assist in the implantation of a specific ankle arthroplasty device.  Indicated to include guiding alignment, making or establishing cuts, and sizing.

## Market data
- **Cleared 510(k) submissions:** 7
- **Registered establishments:** 10
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=OYK)
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