# K211895: BC Reflex Uni Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Bodycad Laboratories, Inc.
- Decided: Aug 20, 2021 after 60 days
- Product code: HSX (Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3520
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K911802 (1992). 70 ancestors in all.
No later device cites it as a predicate yet.
0 of 71 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203697: BC Reflex Uni Knee System, Bodycad Laboratories, Inc. (2021) Summary page 4.

## Indications for use
The patient-specific BC Reflex Uni™ is indicated for unicompartmental knee arthroplasty (UKA) in patients with advanced knee osteoarthritis (OA) of the medial compartment with evidence of adequate healthy bone to support the implanted components. Candidates for unicompartmental knee replacement include those with: * joint impairment due to osteoarthritis or traumatic arthritis of the knee, » varus deformity of the knee, and * as an alternative to tibial osteotomy in patients with unicompartmental OA. The patient-specific BC Reflex Uni™ components fit within an envelope of dimensions that are specific to each patient. The BC Reflex Uni™ femoral component and tibial baseplate are intended for cemented fixation.

Source page: https://510kreport.com/device/K211895
Methodology: https://510kreport.com/methodology