Home / 510(k) Clearances / K242603

510(k) K242603

MyPAO SA guides by Medacta International S.A. — Product Code PBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 19, 2025
Date Received
August 30, 2024
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 Medacta International S.A.

  • K253328 — GMK 3D Metal Tibial Tray Extension (February 26, 2026)
  • K250644 — MSS - Monobloc stem (February 3, 2026)
  • K251043 — Mpact 3D Metal Implants Extension – DMLS Technology (January 28, 2026)
  • K252847 — NextAR Hip Platform (January 9, 2026)
  • K250338 — MSS - Humeral reverse liners extension (October 31, 2025)
  • K250450 — Coated hip implants (September 19, 2025)
  • K252225 — PowerKnot High Strength Sutures (September 12, 2025)
  • K251737 — NextAR(TM) Shoulder Platform (September 4, 2025)
  • K250477 — NextAR(TM) Spine (July 31, 2025)
  • K241461 — Mpact Constrained Liner (July 31, 2025)

Other clearances for product code PBF

  • K250711 — VSP Orthopedics System (December 5, 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)
  • K240066 — Fine Osteotomy™ (February 9, 2024)