Product code OYK— Orthopedic

Cadence Ankle PSI System

Classification name: Ankle Arthroplasty Implantation System
Device class: Class 2
Regulation: 21 CFR 888.3110
Advisory panel: Orthopedic
Total cleared: 7
First cleared: 2020-11-09
Most recent: 2024-10-25

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.”
— U.S. Food and Drug Administration, device classification record for product code OYK under 21 CFR 888.3110, via openFDA

Market context for product code OYK

FDA has cleared 7 devices under product code OYK between 2020 and 2024, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

20244 clearances
20232 clearances
20201 clearance

Top applicants under product code OYK

3D Systems, Inc.5 clearances
Restor3D1 clearance
3D Systems1 clearance

Recent clearances under product code OYK

K243173 — Salto Talaris Ankle PSI System3D Systems, Inc.·2024-10-25
K243174 — Cadence Ankle PSI System3D Systems, Inc.·2024-10-25
K241148 — Salto Talaris Ankle PSI System3D Systems, Inc.·2024-08-30
K241326 — Cadence Ankle PSI System3D Systems, Inc.·2024-08-30
K231585 — Vantage PSI System3D Systems, Inc.·2023-06-30
K223326 — Axiom PSR SystemRestor3D·2023-03-30
K193432 — Vantage PSI System3D Systems·2020-11-09

Data sourced from openFDA. This site is unofficial and independent of the FDA.