# K111536: Metasurg Digifuse Implant

- Pathway: 510(k) (Traditional)
- Applicant: Metasurg
- Decided: Jul 21, 2011 after 49 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: 3 generations back to K013888 (2002). 10 ancestors in all.
30 later devices descend from it; 6 cite it directly.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062863: Osteomed Extended 2.0/2.4CANNULATED Screw System, Osteomed LP (2006) Summary page 1.
- K101165: Pro-Toe VO Hammertow Implant System, Wrightmedicaltechnologyinc (2010)
- K022599: Newdeal K Wire, New Deal, S.A. (2002) Summary page 1.

## Most influential descendants
- K122959: Hammer Toe Implant (2012), 22 descendants of its own
- K140148: Pro-Toe Hammertoe Fixation System (2014), 20 descendants of its own
- K142585: PhaLinx Hammertoe System (2014), 9 descendants of its own
- K150252: PHALINX Hammertoe System (2015), 6 descendants of its own
- K151838: PRO-TOE Hammertoe Fixation System (2015), 4 descendants of its own

## Indications for use
The Metasurg 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. * Hammer toe deformity * Claw toe deformity * Mallet toe deformity * Other deformities of the feet and hands The Metasurg DigiFuse implants are intended for single use only.

Source page: https://510kreport.com/device/K111536
Methodology: https://510kreport.com/methodology