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510(k) K181302

Bodycad Unicompartmental Knee System by Bodycad Laboratories, Inc. — Product Code HSX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 17, 2019
Date Received
May 17, 2018
Clearance Type
Abbreviated
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.

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  • K212307 — BC Reflex Uni Knee System (October 12, 2021)
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Other clearances for product code HSX

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  • 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)