# K072212: Jet-X Bar System Clamps, Bars and Posts-MR Safe

- Pathway: 510(k) (Special)
- Applicant: Smith & Nephew, Inc.
- Decided: Mar 7, 2008 after 211 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.
77 later devices descend from it; 12 cite it directly.
0 of 78 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K093047: Smith & Nephew Circular Fixation System (2010), 51 descendants of its own
- K141078: Orthofix TL-Hex True Lok Hexalobe System (TL-Hex) (2014), 32 descendants of its own
- K143125: Orthofix True Lok Hexapod System VI.3 (2014), 26 descendants of its own
- K152171: Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.4 (2015), 19 descendants of its own
- K110069: Smith & Nephew, Inc Spatialframe V4.1 Web-Based Software (2011), 18 descendants of its own

## Indications for use
Jet-X Bar External Fixation System components are intended to be used on adults or pediatric patients as required and are intended to be used for fracture fixation (open and closed); post-traumatic joint contracture which has resulted in loss of range of motion; fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction; pseudoarthrosis of long bones; limb lengthening by epiphyseal or metaphyseal distraction; correction of bony or soft tissue deformity; correction of segmental bony or soft tissue defects; infected fractures or non-unions; joint arthrodesis; and management of comminuted intra-articular fractures of the distal radius. Jet-X® Bar System Clamps, Bars and Posts - MR Conditional components are for single use only.

Source page: https://510kreport.com/device/K072212
Methodology: https://510kreport.com/methodology