# K122959: Hammer Toe Implant

- Pathway: 510(k) (Traditional)
- Applicant: Trilliant Surgical, Ltd.
- Decided: Nov 7, 2012 after 43 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K013888 (2002). 12 ancestors in all.
22 later devices descend from it; 2 cite it directly.
0 of 35 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 1.
- K081510: Tiger Cannulated Screw System, Trilliant Surgical, Ltd. (2008) Summary page 1.

## Most influential descendants
- 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
- K200840: DuoHex CH Cannulated Hammertoe System (2020), 3 descendants of its own

## Recalls of this device
- Jul 19, 2018 · Class II · Z-1610-2020: Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised dry time parameters. This recall of IFU occurred in 2018.

## Indications for use
The Hammer Toe System implants are intended for fixation of osteotomies and reconstruction of the lesser phalanges during procedures to correct deformities of the lesser toes and fingers. Indications include: hammer toe deformity, claw toe deformity, mallet toe deformity, and other deformities of the foot and hand.

Source page: https://510kreport.com/device/K122959
Methodology: https://510kreport.com/methodology