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OYK — Ankle Arthroplasty Implantation System Class II

FDA Device Classification

Classification Details

Product Code
OYK
Device Class
Class II
Regulation Number
888.3110
Submission Type
Review Panel
OR
Medical Specialty
Orthopedic
Implant
No

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K2431743d systemsCadence Ankle PSI SystemOctober 25, 2024
K2431733d systemsSalto Talaris Ankle PSI SystemOctober 25, 2024
K2411483d systemsSalto Talaris Ankle PSI SystemAugust 30, 2024
K2413263d systemsCadence Ankle PSI SystemAugust 30, 2024
K2315853d systemsVantage PSI SystemJune 30, 2023
K223326restor3dAxiom PSR SystemMarch 30, 2023
K1934323d systemsVantage PSI SystemNovember 9, 2020