Home / 510(k) Clearances / K242746

510(k) K242746

OvertureTi Knee Resurfacing SystemTM by Overture Orthopaedics — Product Code HSX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 7, 2024
Date Received
September 11, 2024
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
Device Class
Class II
Regulation Number
888.3520
Review Panel
OR
Submission Type

Other clearances for product code HSX

  • K251771 — Cambridge Partial Knee (December 16, 2025)
  • K251834 — Persona Partial Knee (August 15, 2025)
  • K251618 — MOTO Partial Knee System Extension (July 24, 2025)
  • K251453 — Arthrex iBalance Partial Knee System (July 1, 2025)
  • K241260 — ACTIFY™ Unicondylar Knee System (December 6, 2024)
  • K242711 — JOURNEY II Unicompartmental Knee System (JOURNEY II UK) (October 30, 2024)
  • K232114 — TRIBRID® Unicompartmental Knee System (April 4, 2024)
  • K221292 — Uni Knee Resurfacing System (March 10, 2023)
  • K212870 — TLC Unicompartmental Knee System (June 16, 2022)
  • K220930 — Restoris Multi-Compartmental Knee System (June 2, 2022)