# K133477: Toegrip, Implant for Proximal Inter-Phalangeal Arthrodesis

- Pathway: 510(k) (Traditional)
- Applicant: Synchro Medical
- Decided: Feb 10, 2014 after 90 days
- Product code: HTY (Pin, Fixation, Smooth)
- 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 K960385 (1996). 9 ancestors in all.
9 later devices descend from it; 3 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031712: Inion Otps Biodegradable Pin, Inion, Ltd. (2003) Summary page 1.
- K070598: Memometal Intra-Medullary Bone Fastener, Models Smart Toe / X-Fuse, Memometal Technologies (2007) Summary page 1.
- K022599: Newdeal K Wire, New Deal, S.A. (2002) Summary page 1.

## Most influential descendants
- K160264: Additive Orthopaedics Hammertoe Correction System (2016), 4 descendants of its own
- K190926: Hammertoe Truss System (HTS) (2019), 3 descendants of its own
- K221283: Hammertoe Truss System (HTS) (2022), 2 descendants of its own
- K132912: Duafit Intergphalangeal Implant, Peek-Fuse Interphalangeal Implant (2014), 2 descendants of its own
- K231453: SnapHammer Hammertoe Correction System (2024), 1 descendant of its own

## Indications for use
The TOEGRIP® is intended for toes for general use in skeletally mature individuals undergoing surgery limited to interdigital fusion. The TOEGRIP® device is intended to be permanently implanted without any other additional device as an intramedullary bone fastener device for toes or fingers. The TOEGRIP® device is indicated for small bone reconstruction limited to interdigital fusion of toes in the following cases, listed in random order: * Rigid PIP joints deformities * Rigid hammertoes deformities * Claw toes deformities (PIP and DIP joints) * Revision hammertoes surgeries * Shortening osteotomies of the proximal phalanx

Source page: https://510kreport.com/device/K133477
Methodology: https://510kreport.com/methodology