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510(k) K231585

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 30, 2023
Date Received
May 31, 2023
Clearance Type
Special
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)
  • 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)
  • K241326 — Cadence Ankle PSI System (August 30, 2024)
  • K231834 — VSP PEEK Cranial Implant (April 4, 2024)
  • 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)
  • K241148 — Salto Talaris Ankle PSI System (August 30, 2024)
  • K223326 — Axiom PSR System (March 30, 2023)
  • K193432 — Vantage PSI System (November 9, 2020)