# K132912: Duafit Intergphalangeal Implant, Peek-Fuse Interphalangeal Implant

- Pathway: 510(k) (Traditional)
- Applicant: In2bones Sas
- Decided: Jul 30, 2014 after 316 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K911837 (1991). 99 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 102 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022599: Newdeal K Wire, New Deal, S.A. (2002) Summary page 2.
- K111536: Metasurg Digifuse Implant, Metasurg (2011) Summary page 3.
- K102326: Parcus 3.5MM Peek CF Push-in Suture Anchor, Parcus Medical, LLC (2010) Summary page 2.
- K120645: Pro-Toe (TM) VO Hamertoe Implant System-Line Sddition, Wrightmedicaltechnologyinc (2012) Summary page 2.
- K112675: Arrow-Lok Digital System, Arrowhead Medical Device Technologies, LLC (2011)
- K071586: Bioraptor 2.3 PK Suture Anchor, Smith & Nephew Inc., Endoscopy Division (2007) Summary page 2.
- K100414: Protoe Endosorb Small Hammer Toe Pin, Merete Medical GmbH (2010) Summary page 2.
- K133477: Toegrip, Implant for Proximal Inter-Phalangeal Arthrodesis, Synchro Medical (2014). Cleared while this submission was under review Summary page 3.

## Most influential descendants
- K222564: Treace Medical Concepts (TMC) Hammertoe Fixation System (2022), 0 descendants of its own
- K151241: Synchro-Medical TIGER TRACK Screw System (2015), 0 descendants of its own

## Recalls of this device
- Mar 9, 2015 · Class II · Z-1318-2015: Dimensional non-conformity leading to the impossibility to introduce the implant in the dedicated holder.
- Mar 9, 2015 · Class II · Z-1319-2015: Dimensional non-conformity leading to the impossibility to introduce the implant in the dedicated holder.

## Indications for use
The DUAFIT® interphalangeal implant is intended for fixation of proximal interphalangeal joint arthrodesis of the lesser toes. Examples include: Rigid or semi-rigid deformity of the PIP joint Revision of failed arthroplasty or arthrodesis 2nd toe shortening.

Source page: https://510kreport.com/device/K132912
Methodology: https://510kreport.com/methodology