# K083636: Reprocessed External Fixation Device

- Pathway: 510(k) (Traditional)
- Applicant: Sterilmed, Inc.
- Decided: Mar 2, 2009 after 83 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 Original Ilizarov External Fixation System: named in the summary without a submission number

## Indications for use
Post-traumatic joint contracture'which has resulted in loss of range of motion. Fractures and disease which generally may result injoint contractures or loss of range of motion and fractures requiring distraction. Open and closed fracture fixation. Pseudoarthrosis of long bones. Limb lengthening by epiphyseal or metaphyseal distraction. Correction of bony or soft tissue deformities. Correction of segmental bony or soft tissue defects. Joint arthrodesis. Infected fractures or nonunions. Management of comminuted intra-articular fractures of the distal radius.

Source page: https://510kreport.com/device/K083636
Methodology: https://510kreport.com/methodology