# K032902: Subtalar Arthrorisis Implant

- Pathway: 510(k) (Traditional)
- Applicant: Nexa Orthopedics, Inc.
- Decided: Dec 15, 2003 after 89 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: 1 generation back to K001231 (2000). 1 ancestor in all.
49 later devices descend from it; 6 cite it directly.
0 of 51 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001231: The Kalix Implant, New Deal, S.A. (2000)

## Most influential descendants
- K071498: Subtalar Implant (2007), 32 descendants of its own
- 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

## Indications for use
The Futura Biomedical Arthrorisis Implant is intended to treat hyperpronated foot and stabilize the subtalar joint. It is intended to block forward, downward and medial displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela. Examples include: Flat foot treatment in children and adolescents Congenital flat foot Unsuccessful long term orthopaedic treatment (shoes, insoles...) Tarsal coalitions Painful flat foot Supple deformity in posterior tibial tendon dysfunction Paralytic flat foot Subtalar instability

Source page: https://510kreport.com/device/K032902
Methodology: https://510kreport.com/methodology