# K041936: Biopro Subtalar Implant

- Pathway: 510(k) (Traditional)
- Applicant: Biopro, Inc.
- Decided: Sep 8, 2004 after 51 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: 2 generations back to K792670 (1980). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 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.

## Indications for use
The Biopro subtalar implant is indicated for use in the treatment of the hyperpronated foot and stabilization of the subtalar joint. It is designed to block forward, downward and medial displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela. Conditions include: Flat foot treatment in children and adolescents Congenital flat foot Unsuccessful long term orthopedic treatment (orthodics) Tarsal coalitions Painfully flat foot Supple deformity in posterior tibial tendon dysfunction Paralytic flat foot Subtalar instability

Source page: https://510kreport.com/device/K041936
Methodology: https://510kreport.com/methodology