# K071498: Subtalar Implant

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Sports Medicine, Inc.
- Decided: Jul 31, 2007 after 61 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K792670 (1980). 4 ancestors in all.
32 later devices descend from it; 1 cites it directly.
0 of 37 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.
- K032902: Subtalar Arthrorisis Implant, Nexa Orthopedics, Inc. (2003) Summary page 1.
- K001231: The Kalix Implant, New Deal, S.A. (2000) Summary page 1.

## Most influential descendants
- K133636: Extremity Medical Hammertoe Device (2014), 31 descendants of its own
- K141857: CrossTie Intraosseous Fixation System (2015), 16 descendants of its own
- K151270: CrossTIE Intraosseous Fixation System (2015), 15 descendants of its own
- K181872: MIS Bunion System (2019), 14 descendants of its own
- K221181: Treace Medical Concepts (TMC) Plating System (2023), 7 descendants of its own

## Recalls of this device
- Jan 21, 2011 · Not classified · Z-1618-2011: The firm has initiated this recall following internal fatigue testing that shows possible initiation of fatigue cracking in implants under load.
- Jan 21, 2011 · Not classified · Z-1614-2011: The firm has initiated this recall following internal fatigue testing that shows possible initiation of fatigue cracking in implants under load.
- Jan 21, 2011 · Not classified · Z-1613-2011: The firm has initiated this recall following internal fatigue testing that shows possible initiation of fatigue cracking in implants under load.
- Jan 21, 2011 · Not classified · Z-1615-2011: The firm has initiated this recall following internal fatigue testing that shows possible initiation of fatigue cracking in implants under load.
- Jan 21, 2011 · Not classified · Z-1616-2011: The firm has initiated this recall following internal fatigue testing that shows possible initiation of fatigue cracking in implants under load.
- Jan 21, 2011 · Not classified · Z-1617-2011: The firm has initiated this recall following internal fatigue testing that shows possible initiation of fatigue cracking in implants under load.
- Jan 21, 2011 · Not classified · Z-1612-2011: The firm has initiated this recall following internal fatigue testing that shows possible initiation of fatigue cracking in implants under load.

## Indications for use
The Subtalar Implant is indicated for use in treating the hyperpronated foot by stabilizing the subtalar joint. It is intended to block forward, downward, and medial displacement of the talus, thereby limiting the excessive eversion of the hindfoot. Examples include, but are not limited to: * Symptomatic acquired flat foot treatment in children and adolescents * Symptomatic congenital flexible flat foot * Tarsal coalitions when associated with the flatfoot deformity * Posterior tibial tendon dysfunction with supple feet * Paralytic flat foot * Subtalar Instability * Severely pronated foot

Source page: https://510kreport.com/device/K071498
Methodology: https://510kreport.com/methodology