# K180580: Medline ReNewal Reprocessed Smith & Nephew Jet-X External Fixation Devices

- Pathway: 510(k) (Traditional)
- Applicant: Surgical Instrument Service and Savings, Inc.
- Decided: Jul 27, 2018 after 144 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: 1 generation back to K072212 (2008). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072212: Jet-X Bar System Clamps, Bars and Posts-MR Safe, Smith & Nephew, Inc. (2008) Summary page 6.

## Indications for use
Medline ReNewal Reprocessed Smith & Nephew Jet-X External Fixation devices 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 or non-union 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; joint arthrodesis; and management of comminuted intra-articular fractures of the distal radius. Medline ReNewal Reprocessed Smith & Nephew Jet-X External Fixation devices are for single use only.

Source page: https://510kreport.com/device/K180580
Methodology: https://510kreport.com/methodology