# K200491: Bfix Orthopedic External Fixator Systems

- Pathway: 510(k) (Traditional)
- Applicant: Aike (Shanghai) Medical Instrument Co., Ltd.
- Decided: Jan 5, 2021 after 312 days
- Product code: KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K831576 (1983). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113770: Orthofix Galaxy Fixation System, Orthofix Srl (2012) Summary page 4.

## Indications for use
The Bfix® Orthopedic External Fixator Systems is intended to be used on adults patients for bone stabilization in the lower limbs. The indication for use includes: - open or closed fractures in long bones; - bone defects or reconstructive procedure - limb lengthening

Source page: https://510kreport.com/device/K200491
Methodology: https://510kreport.com/methodology