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510(k) K241148

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 30, 2024
Date Received
April 25, 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.

  • K250711 — VSP Orthopedics System (December 5, 2025)
  • K243173 — Salto Talaris Ankle PSI System (October 25, 2024)
  • K243174 — Cadence Ankle PSI System (October 25, 2024)
  • K241326 — Cadence 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)
  • K193432 — Vantage PSI System (November 9, 2020)

Other clearances for product code OYK

  • K243173 — Salto Talaris Ankle PSI System (October 25, 2024)
  • K243174 — Cadence Ankle PSI System (October 25, 2024)
  • K241326 — Cadence 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)