# K223112: MAVERICK Mini External Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Dec 8, 2022 after 66 days
- Product code: JDW (Pin, Fixation, Threaded)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K994143 (2000). 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)
- K213874: MAVERICK External Fixation System, Smith & Nephew, Inc. (2022) Summary page 4.
- K994143: Smith & Nephew External Fixation System [Unilateral (Linear) & Multilateral (Circular) Fixators and Accessories], Smith & Nephew, Inc. (2000) Summary page 4.

## Indications for use
Smith & Nephew's MAVERICK and MAVERICK Mini External Fixation System is intended to be used for temporary stabilization of the long bones, feet, pelvis, and wrist. The indications for the Smith & Nephew MAVERICK Mini External Fixation System are the following: * Open and closed fracture fixation * Bony or soft tissue deformities

Source page: https://510kreport.com/device/K223112
Methodology: https://510kreport.com/methodology