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510(k) K241326

Cadence Ankle PSI System by 3D Systems, Inc. — Product Code OYK

K241326 is an FDA 510(k) premarket notification submitted by 3D Systems, Inc. for the device "Cadence Ankle PSI System". The FDA issued a decision of Substantially Equivalent on August 30, 2024. The device falls under product code OYK (Ankle Arthroplasty Implantation System), a Class II device regulated under 21 CFR 888.3110. 3D Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 30, 2024
Date Received
May 10, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ankle Arthroplasty Implantation System
Device Class
Class II
Regulation Number
888.3110
Review Panel
OR
Submission Type

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.

Other clearances by 3D Systems, Inc.

  • K261826 — VSP System (Titanium Palatal Splint) (June 3, 2026)
  • K250711 — VSP Orthopedics System (December 5, 2025)
  • K243174 — Cadence Ankle PSI System (October 25, 2024)
  • K243173 — Salto Talaris Ankle PSI System (October 25, 2024)
  • K241148 — Salto Talaris Ankle PSI System (August 30, 2024)
  • K231834 — VSP PEEK Cranial Implant (April 4, 2024)
  • K231585 — Vantage PSI System (June 30, 2023)
  • K214093 — VSP Bolus (March 30, 2022)
  • K211244 — VSP® Orthopedics System (November 10, 2021)
  • K210347 — VSP System (April 26, 2021)

Other clearances for product code OYK

  • K243173 — Salto Talaris Ankle PSI System (October 25, 2024)
  • K243174 — Cadence Ankle PSI System (October 25, 2024)
  • K241148 — Salto Talaris Ankle PSI System (August 30, 2024)
  • K231585 — Vantage PSI System (June 30, 2023)
  • K223326 — Axiom PSR System (March 30, 2023)
  • K193432 — Vantage PSI System (November 9, 2020)

FDA data resources