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510(k) K211614

CenterMed Patient Matched Assisted Surgical Planning (ASP) System by Centermed, Inc. — Product Code PBF

K211614 is an FDA 510(k) premarket notification submitted by Centermed, Inc. for the device "CenterMed Patient Matched Assisted Surgical Planning (ASP) System". The FDA issued a decision of Substantially Equivalent on August 4, 2022. The device falls under product code PBF (Orthopaedic Surgical Planning And Instrument Guides), a Class II device regulated under 21 CFR 888.3030. Centermed, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 4, 2022
Date Received
May 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 Centermed, Inc.

  • K201353 — CenterMed Patient Matched Assisted Surgical Planning (ASP) System (June 28, 2021)

Other clearances for product code PBF

  • K252064 — MedCAD® AccuStride™ System (March 27, 2026)
  • 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)

FDA data resources