Device type
Ankle Arthroplasty Implantation System
Product code OYK · Class II · 21 CFR 888.3110 · Orthopedic
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.
Recent 510(k)s
No 510(k) clearances in the archive for OYK.
Recent recalls
Sep 23, 2026
Z-3178-2026
Kinos Axiom Total Ankle System with Axiom PSR, Flat-cut (Cut Guide), REF: 5831-9006
restor3d Inc.
- OYK
- Class II
- Ongoing