# K152527: Integra DigiFuse Cannulated Intramedullary Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Ascension Orthopedics
- Decided: Oct 29, 2015 after 56 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K013888 (2002). 11 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111536: Metasurg Digifuse Implant, Metasurg (2011) Summary page 4.
- K062863: Osteomed Extended 2.0/2.4CANNULATED Screw System, Osteomed LP (2006) Summary page 4.
- K022599: Newdeal K Wire, New Deal, S.A. (2002) Summary page 4.

## Most influential descendants
- K210016: Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot System,Integra CAPTURE Screw System & Integra Ti6 Internal Fixation System,Subtalar MBA System,MetaSurg Subtalar Implant,NewDeal BOLD Screw,NewDeal HALLU Lock Plate System,NewDeal HALLU Plates,QWIX Positioning Screw,SPIN Snap-Off Screw,NewDeal TIBIAXYS System (2021), 0 descendants of its own

## Indications for use
The DigiFuse® implant is indicated for the fixation of osteotomies and reconstruction of the lesser phalanges during procedures to correct deformities of the toes and fingers. Indications include: * Hammer toe deformity * Claw toe deformity » Mallet toe deformity * Other deformities of the feet and hands The DigiFuse® implants are intended for single use only.

Source page: https://510kreport.com/device/K152527
Methodology: https://510kreport.com/methodology