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510(k) K250394

Fine TTO™ by Bodycad Laboratories, Inc. — Product Code PBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 21, 2025
Date Received
February 12, 2025
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 Bodycad Laboratories, Inc.

  • K253300 — Fine Osteotomy™ (October 28, 2025)
  • K250923 — Fine Osteotomy™ (August 21, 2025)
  • K241356 — Fine Osteotomy™ (September 5, 2024)
  • K240703 — Fine Osteotomy™ (April 12, 2024)
  • K240066 — Fine Osteotomy™ (February 9, 2024)
  • K231314 — Fine Osteotomy™ (June 2, 2023)
  • K212307 — BC Reflex Uni Knee System (October 12, 2021)
  • K211895 — BC Reflex Uni Knee System (August 20, 2021)
  • K211646 — FINE Osteotomy (July 28, 2021)
  • K203697 — BC Reflex Uni Knee System (March 12, 2021)

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)
  • 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)
  • K240066 — Fine Osteotomy™ (February 9, 2024)