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BC Reflex Uni Knee System

by Bodycad Laboratories, Inc. 510(k) 4 variants

Active United States

510(k) K212307

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK212307 Date12 Oct 2021ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
HSX
Device Class
Class II
Regulation
21 CFR Part 888.3520
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The BC Reflex Uni Knee System is a unicompartmental knee system designed for personalized restoration of a patient's anatomy and kinematics. It is based on proprietary 3D rendering and digital planning to optimize implant fit and function.

The device is supplied as part of a personalized restoration procedure and is intended for use in orthopedic applications. It has received FDA 510(k) clearance under K212307 and K211895, with review conducted by the Orthopedic advisory committee. The system is manufactured by Bodycad Laboratories, Inc. in Quebec City, Canada.

Other devices from Bodycad Laboratories, Inc.

See all devices from Bodycad Laboratories, Inc. →

Questions

AI-generated answers, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the BC Reflex Uni Knee System used for?

    The BC Reflex Uni Knee System is designed for personalized restoration of a patient's anatomy and kinematics in unicompartmental knee applications, using proprietary 3D rendering and digital planning to optimize implant fit and function based on individual patient data.

  • How is the BC Reflex Uni Knee System supplied to clinicians?

    The device is supplied as part of a personalized restoration procedure, meaning each implant is manufactured specifically for an individual patient based on their anatomical data and digital preoperative planning, rather than as a standard off-the-shelf component.

  • Is the BC Reflex Uni Knee System intended for single-use or reuse?

    The BC Reflex Uni Knee System is intended for single-use implantation in a surgical procedure, as it is a personalized implant designed and manufactured for one specific patient's anatomy and is not designed to be removed, reprocessed, or reused in another patient.

  • What regulatory pathway was used for the BC Reflex Uni Knee System?

    The BC Reflex Uni Knee System received FDA 510(k) clearance under submission numbers K212307 and K211895, with the review conducted by the Orthopedic advisory committee, indicating it was found substantially equivalent to legally marketed predicate devices.