# K100795: Jet-X Bar System Clamps and Posts Reprocessing

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Sep 2, 2010 after 164 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: 2 generations back to K994143 (2000). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031181: External Fixation Systems, Smith & Nephew, Inc. (2003) Summary page 2.
- K042312: Jet-X Bar Clamps and Pin Clamps-Non-Magnetic/MR Safe, Smith & Nephew, Inc. (2004) Summary page 2.
- K072212: Jet-X Bar System Clamps, Bars and Posts-MR Safe, Smith & Nephew, Inc. (2008) Summary page 2.

## Indications for use
Jet-X External Fixation System components are intended to be used on adults or pediatric patients as required and are intended to be used for 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; open and closed fracture fixation; pseudoarthrosis of long bones; correction of bony or soft tissue deformities; correction of segmental bony or soft tissue defects; joint arthrodesis; infected fractures or nonunions; mini external fixator systems are indicated for the management of comminuted intra-articular fractures of the distal radius.

Source page: https://510kreport.com/device/K100795
Methodology: https://510kreport.com/methodology