# K142478: opti-Toe

- Pathway: 510(k) (Traditional)
- Applicant: Graham Medical Technologies, LLC (D.B.A.Gramedica)
- Decided: May 29, 2015 after 268 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: 5 generations back to K960385 (1996). 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)
- K122031: Nextra TI Hammertoe Correction System, Nextremity Solutions, LLC (2012) Summary page 4.
- K142490: ProxiFuse Hammer Toe Device, Cartiva, Inc. (2014). Cleared while this submission was under review Summary page 4.

## Most influential descendants
- K162685: 2-Piece Hammertoe Correction System (2017), 0 descendants of its own

## Indications for use
The GraMedica opti-Toe Device is indicated for reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe. The GraMedica opti-Toe components are to be cemented in place and assembled for reconstruction of the toe. Patients should protect their weight-bearing or heel weight-bearing only until soft tissue healing has occurred.

Source page: https://510kreport.com/device/K142478
Methodology: https://510kreport.com/methodology