# K260112: QuikFix External Fixator: Knee-Spanning Pack

- Pathway: 510(k) (Traditional)
- Applicant: Stabiliz Orthopaedics, Inc.
- Decided: Mar 23, 2026 after 68 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Smith and Nephew Jet-X Bar System Clamps, Bars and Posts: named in the summary without a submission number
- (no number) Stryker Hoffman II Modular External Fixation System: named in the summary without a submission number

## Indications for use
The QuikFix External Fixator: Knee-Spanning Pack is indicated for treatment of long bone fractures of the leg that require external fixation. Specifically, the system is intended for: * Temporary stabilization of open or closed acute fractures with lower limb soft tissue injuries; * Temporary stabilization of lower limb fractures in the context of polytrauma; * Temporary stabilization of lower limbs after removal of total joint (knee, and ankle) arthroplasty for infection or other failure; * Temporary stabilization of lower limb non-unions; * Intra-operative temporary stabilization tool of the lower limb to assist with indirect reduction. QuikFix External Fixator: Knee-Spanning Pack is intended for use in a non-weight bearing patient. QuikFix External Fixator: Knee-Spanning Pack components are for single use only and are suitable for use in an MR environment.

Source page: https://510kreport.com/device/K260112
Methodology: https://510kreport.com/methodology