# K170482: Spider Frame External Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Tasarimmed Tibbi Mamuller Sanayi VE Ticaret A.S
- Decided: Sep 27, 2017 after 223 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Spider Frame Computer Assisted External Fixation system used as a temporary or permanent method of correction and stabilization of the extremity bones. Indications are: 1. Post-Traumatic joint contracture which has resulted in loss of range of motion 2. 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 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,

Source page: https://510kreport.com/device/K170482
Methodology: https://510kreport.com/methodology