BC Reflex Uni Knee System
by Bodycad Laboratories, Inc. 510(k)
Active
510(k) K211895
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK211895 | Date20 Aug 2021 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 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, 21 Sep 2026
The BC Reflex Uni Knee System is an orthopedic device, classified under the product code HSX. It is a unicompartmental knee system designed to provide a personalized restoration of a patient's anatomy and kinematics.
The BC Reflex Uni Knee System is supplied by Bodycad Laboratories, Inc. and has received FDA 510K authorization. The device is intended for use in orthopedic procedures, and its safety and effectiveness have been summarized in accordance with 21 CFR 807.92 of the Federal Code of Regulations.
Other devices from Bodycad Laboratories, Inc.
Questions
AI-generated answers, 21 Sep 2026
What is the BC Reflex Uni Knee System used for?
The BC Reflex Uni Knee System is intended for use in orthopedic procedures to provide a personalized restoration of a patient's anatomy and kinematics.
Is the BC Reflex Uni Knee System supplied sterile?
The device data does not specify if the BC Reflex Uni Knee System is supplied sterile, it is recommended to consult the manufacturer's instructions for use.
What is the regulatory status of the BC Reflex Uni Knee System?
The BC Reflex Uni Knee System has received FDA 510K authorization, indicating that it is substantially equivalent to a predicate device.