# K200123: Accessories for the SixFix® Hexapod Fixator

- Pathway: 510(k) (Traditional)
- Applicant: Arrowhead De, LLC
- Decided: Sep 22, 2020 after 245 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: 15 generations back to K962616 (1996). 73 ancestors in all.
No later device cites it as a predicate yet.
0 of 74 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190069: SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS), Arrowhead De, LLC (2019) Summary page 4.
- K141078: Orthofix TL-Hex True Lok Hexalobe System (TL-Hex), Orthofix Srl (2014) Summary page 4.
- K161753: Hoffman LRF System, Stryker GmbH (2016) Summary page 4.
- K163656: Hoffmann LRF System, Stryker GmbH (2017) Summary page 4.
- K182968: Hoffmann LRF System, Stryker GmbH (2019) Summary page 4.

## Indications for use
INDICATIONS for Accessories for the SixFix Hexapod Fixator (Reduction Struts, Foot Arches with Locking Hinges, Motion Hinge, Variable Angle Clamps) The SixFix® Hexapod Fixator is 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; pseudo-arthrosis of long bones; limb lengthening by epiphyseal or metaphyseal distraction; correction of bony or soft tissue deformities; correction of bony or soft tissue defects; joint arthrodesis; infected fractures or nonunions.

Source page: https://510kreport.com/device/K200123
Methodology: https://510kreport.com/methodology