# K103183: Trilliant Surgical Subtalar Implant

- Pathway: 510(k) (Traditional)
- Applicant: Trilliant Surgical, Ltd.
- Decided: Feb 8, 2011 after 103 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: 5 generations back to K792670 (1980). 13 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960692: Subtalar Mba System, Kinetikos Medical, Inc. (1996) Summary page 1.
- K042030: Hyprocure Subtalar Implant System, Graham Medical Technologies, LLC (2004) Summary page 1.
- K093820: Subfix Arthroereisis Implant, Models SUT0065, SUT0080, SUT0090, SUT0100, SUT0115, Memometal Technologies (2010) Summary page 1.

## Most influential descendants
- K111834: Disco Subtalar Implant (2011), 3 descendants of its own
- K133035: Normed Pellegrin Calcaneus Stop Screw (2013), 2 descendants of its own
- K160548: MC-Subtalar (TM) II (2016), 0 descendants of its own
- K140962: Normed Vario Subtalar Screw (2014), 0 descendants of its own

## Recalls of this device
- Jul 19, 2018 · Class II · Z-1607-2020: 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 Trilliant Surgical Subtalar Implant is indicated for the use in the treatment of the hyperpronated foot and stabilization of the subtalar joint. It is intended to block the forward, downward, and medial displacement of the talus, thus allowing normal subtalar joint motion but limiting excessive pronation.

Source page: https://510kreport.com/device/K103183
Methodology: https://510kreport.com/methodology