# K254087: MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (USA) Products, LLC
- Decided: Jun 11, 2026 after 175 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: 13 generations back to K962616 (1996). 57 ancestors in all.
No later device cites it as a predicate yet.
0 of 58 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202810: AutoStrut G2, Orthospin, Ltd. (2021) Summary page 5.
- K211313: MAXFRAME Multi-Axial Correction System (aka MAXFRAME), Synthes (USA) Products, LLC (2021) Summary page 5.

## Indications for use
The MAXFRAME AUTOSTRUTTM with Bluetooth Multi-Axial Correction System is indicated for the following treatments in adults, and in both children (3-12) and adolescents (12-21) in which the growth plates have fused or 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 seqmental defects

Source page: https://510kreport.com/device/K254087
Methodology: https://510kreport.com/methodology