# K161417: DePuy Synthes MAXFRAME Multi-Axial Correction System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes USA, LLC
- Decided: Nov 10, 2016 after 171 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: 10 generations back to K962616 (1996). 53 ancestors in all.
8 later devices descend from it; 4 cite it directly.
0 of 62 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093047: Smith & Nephew Circular Fixation System, Smith & Nephew, Inc. (2010) Summary page 5.
- K092190: Synthes Distraction Osteogenesis System, MR Conditional with Expanded Indications, Synthes (Usa) (2010) Summary page 5.

## Most influential descendants
- K191241: AutoStrut (2019), 4 descendants of its own
- K202810: AutoStrut G2 (2021), 3 descendants of its own
- K211313: MAXFRAME Multi-Axial Correction System (aka MAXFRAME) (2021), 2 descendants of its own
- K241563: Extremity Medical External Fixation System (2025), 1 descendant of its own
- K231922: DEPUY SYNTHES MAXFRAME AUTOSTRUT System (2023), 1 descendant of its own

## Indications for use
The DePuy Synthes MAXFRAME™ 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 segmental defects.

Source page: https://510kreport.com/device/K161417
Methodology: https://510kreport.com/methodology