# K202810: AutoStrut G2

- Pathway: 510(k) (Traditional)
- Applicant: Orthospin, Ltd.
- Decided: Jan 6, 2021 after 105 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: 12 generations back to K962616 (1996). 55 ancestors in all.
3 later devices descend from it; 2 cite 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)
- K191241: AutoStrut, Orthospin (2019) Summary page 4.

## Most influential descendants
- 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 G2 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/K202810
Methodology: https://510kreport.com/methodology