# K191241: AutoStrut

- Pathway: 510(k) (Traditional)
- Applicant: Orthospin
- Decided: Aug 14, 2019 after 98 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: 11 generations back to K962616 (1996). 54 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 59 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161417: DePuy Synthes MAXFRAME Multi-Axial Correction System, Synthes USA, LLC (2016) Summary page 4.

## Most influential descendants
- K202810: AutoStrut G2 (2021), 3 descendants of its own
- K231922: DEPUY SYNTHES MAXFRAME AUTOSTRUT System (2023), 1 descendant of its own
- K254087: MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction System (2026), 0 descendants of its own
- K253202: Hoffmann LRF System (2025), 0 descendants of its own

## Indications for use
AutoStrut is indicated for the following treatments in adults, and in both children (3-12) and adolescents (12-21) in which growth plates have fused and will not be crossed with hardware: * fracture fixation (open and closed) * pseudoarthrosis of long bones * limb lengthening (epiphyseal or metaphyseal distraction) * joint arthrodesis * infected fractures or nonunions * correction of bony or soft tissue deformities * correction of segmental defects.

Source page: https://510kreport.com/device/K191241
Methodology: https://510kreport.com/methodology