OYK · Class II · 21 CFR 888.3110

FDA Product Code OYK: Ankle Arthroplasty Implantation System

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.

Leading manufacturers include 3D Systems, Inc., 3D Systems and Restor3d.

7
Total
7
Cleared
115d
Avg days
2020
Since
Declining activity - 2 submissions in the last 2 years vs 4 in the prior period
Review times improving: avg 25d recently vs 151d historically

FDA 510(k) Cleared Ankle Arthroplasty Implantation System Devices (Product Code OYK)

7 devices
1–7 of 7
Cleared Oct 25, 2024
Salto Talaris Ankle PSI System
K243173
3D Systems, Inc.
Orthopedic · 25d
Cleared Oct 25, 2024
Cadence Ankle PSI System
K243174
3D Systems, Inc.
Orthopedic · 25d
Cleared Aug 30, 2024
Salto Talaris Ankle PSI System
K241148
3D Systems, Inc.
Orthopedic · 127d
Cleared Aug 30, 2024
Cadence Ankle PSI System
K241326
3D Systems, Inc.
Orthopedic · 112d
Cleared Jun 30, 2023
Vantage PSI System
K231585
3D Systems, Inc.
Orthopedic · 30d
Cleared Mar 30, 2023
Axiom PSR System
K223326
Restor3d
Orthopedic · 150d
Cleared Nov 09, 2020
Vantage PSI System
K193432
3D Systems
Orthopedic · 335d

About Product Code OYK - Regulatory Context

510(k) Submission Activity

7 total 510(k) submissions under product code OYK since 2020, with 7 receiving FDA clearance (average review time: 115 days).

Submission volume has declined in recent years - 2 submissions in the last 24 months compared to 4 in the prior period.

FDA 510(k) Review Time - OYK Product Code

Recent submissions under OYK have taken an average of 25 days to reach a decision - down from 151 days historically, suggesting improved FDA processing for this classification.

OYK devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →