510(k) K211244

VSP® Orthopedics System by 3D Systems — Product Code PBF

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: November 10, 2021
Date Received: April 26, 2021
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Orthopaedic Surgical Planning And Instrument Guides
Device Class: Class II
Regulation Number: 888.3030
Review Panel: OR
Submission Type

As a surgical instrument to assist in pre-operative planning and/or guiding the marking of bone and/or guide surgical instruments for orthopedic surgical procedures.

Other clearances by 3D Systems

K250711 — VSP Orthopedics System (December 5, 2025)
K243174 — Cadence Ankle PSI System (October 25, 2024)
K243173 — Salto Talaris Ankle PSI System (October 25, 2024)
K241326 — Cadence Ankle PSI System (August 30, 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)
K210347 — VSP System (April 26, 2021)
K193432 — Vantage PSI System (November 9, 2020)

Other clearances for product code PBF

K250711 — VSP Orthopedics System (December 5, 2025)
K242603 — MyPAO SA guides (November 19, 2025)
K251709 — MedCAD® AccuStride System (November 4, 2025)
K250394 — Fine TTO (October 21, 2025)
K250767 — Newclip Patient-matched instrumentation non sterile PSI (October 1, 2025)
K250921 — CORIOGRAPH Pre-Op Planning and Modeling Services (June 25, 2025)
K241811 — MedCAD® AccuStride System (March 13, 2025)
K243912 — Newclip Patient-matched instrumentation non sterile PSI (February 13, 2025)
K240415 — Newclip Patient-matched instrumentation non sterile PSI (November 7, 2024)
K240113 — CORIOGRAPH Knee Pre-Op Plan (March 18, 2024)