BC Reflex Uni Knee System

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K203697 ↗

FDA Product Code

HSX

Device Class

Class II

Regulation

21 CFR Part 888.3520

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Fine Osteotomy

  Class II

  FDA 510(k) K240066 Active Cleared 9 Feb 2024

• Fine Osteotomy™

  Class II

  FDA 510(k) K253300 Active Cleared 28 Oct 2025

• Bodycad Unicompartmental Knee System

  Class II

  FDA 510(k) K163700 Active Cleared 29 Mar 2017

• Fine TTO™

  Class II

  FDA 510(k) K250394 Active Cleared 21 Oct 2025

• BC Reflex Uni Knee System

  Class II

  FDA 510(k) K211895 Active Cleared 20 Aug 2021

• FINE Osteotomy around the knee

  Class II

  FDA 510(k) K193614 Active Cleared 25 Mar 2020

See all devices from Bodycad Laboratories, Inc. →