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510(k) K212307

BC Reflex Uni Knee System by Bodycad Laboratories, Inc. — Product Code HSX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 12, 2021
Date Received
July 23, 2021
Clearance Type
Traditional
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 by Bodycad Laboratories, Inc.

  • K253300 — Fine Osteotomy™ (October 28, 2025)
  • K250394 — Fine TTO™ (October 21, 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)
  • 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 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)
  • K242746 — OvertureTi Knee Resurfacing SystemTM (October 7, 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)