# K081342: Reprocessed External Fixation Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Sterilmed, Inc.
- Decided: Aug 13, 2008 after 92 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 & Nephew Jet-XC® External Fixation System: named in the summary without a submission number

## Indications for use
The reprocessed fixation device is indicated for use with adults and pediatric patients and intended for fracture fixation (open and closed) fractures and disease generally resulting in joint contractures or loss of range and fractures requiring distraction; post-traumatic joint contracture which has resulted in loss of range of motion; pseudoarthrosis or non-union of long bones; limb lengthening by epiphyseal or metaphyseal distraction; joint arthrodesis; correction of segmental bony or soft tissues; and management of comminuted intra-articular fractures of the distal radius.

Source page: https://510kreport.com/device/K081342
Methodology: https://510kreport.com/methodology