# K053543: Arthrex Arthoeresis Implant

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Apr 3, 2006 after 104 days
- Product code: HWC (Screw, Fixation, Bone)
- 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 K792670 (1980). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 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.
- K001231: The Kalix Implant, New Deal, S.A. (2000) Summary page 1.
- K042030: Hyprocure Subtalar Implant System, Graham Medical Technologies, LLC (2004) Summary page 1.
- K031155: Osteomed Subtalar Implant System, Osteomed LP (2003) Summary page 1.

## Indications for use
The Arthrex Subtalar (Arthoeresis) Implant is intended to assist 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 excessive eversion of the hindfoot Examples include: * Symptomatic acquired flat foot treatment in children and adolescents * Symptomatic congenital flexible flat foot * Tarsal coalitions when associated with a flatfoot deformity * Posterior tibial tendon dysfunction with supple feet * Paralytic flat foot

Source page: https://510kreport.com/device/K053543
Methodology: https://510kreport.com/methodology