Home / 510(k) Clearances / K223421

510(k) K223421

MedCAD AccuPlan Orthopedics System by Medcad — Product Code PBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 2023
Date Received
November 10, 2022
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 Medcad

  • K251709 — MedCAD® AccuStride™ System (November 4, 2025)
  • K241811 — MedCAD® AccuStride™ System (March 13, 2025)
  • K230398 — MedCAD® AccuPlate® 3DTi Patient-Specific Plating System (September 26, 2023)
  • K223024 — MedCAD AccuPlan System (March 7, 2023)
  • K220357 — MedCAD AccuShape Titanium Patient-Specific Cranial Implant (August 26, 2022)
  • K193280 — MedCAD® AccuPlate® Patient-Specific Plate (February 12, 2021)
  • K192282 — MedCAD® AccuPlan® System (October 29, 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)