OYK

Ankle Arthroplasty Implantation System

Product code: OYK
Device name: Ankle Arthroplasty Implantation System
Device class: Class 2
21 CFR: 21 CFR 888.3110
Medical specialty: Orthopedic
Marketing pathway: 510(K)
510(k) clearances (last 3 years): 7

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (4)

Last three years. Most recent: 2024-10-25.

Number	Decision date	Applicant	Device name	Summary
K243173	2024-10-25	3D Systems, Inc.	Salto Talaris Ankle PSI System	PDF
K243174	2024-10-25	3D Systems, Inc.	Cadence Ankle PSI System	PDF
K241326	2024-08-30	3D Systems, Inc.	Cadence Ankle PSI System	PDF
K241148	2024-08-30	3D Systems, Inc.	Salto Talaris Ankle PSI System	PDF

4 summaries are archived here for direct download.

Official FDA classification page: OYK

Classification and pathway per current FDA publications. Data from openFDA (CC0).