# K033046: Subtalar Peg Implant

- Pathway: 510(k) (Traditional)
- Applicant: Nexa Orthopedics, Inc.
- Decided: Dec 23, 2003 after 85 days
- Product code: MJW (Prosthesis, Subtalar, Plug, Polymer)
- 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 K792670 (1980). 1 ancestor in all.
9 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K792670: Smith Subtalar Peg, Dow Corning Wright (1980) Summary page 4.
- (no number) Wright Medical STA-Peg implant: named in the summary without a submission number

## Most influential descendants
- K093820: Subfix Arthroereisis Implant, Models SUT0065, SUT0080, SUT0090, SUT0100, SUT0115 (2010), 8 descendants of its own
- K103183: Trilliant Surgical Subtalar Implant (2011), 4 descendants of its own
- K111834: Disco Subtalar Implant (2011), 3 descendants of its own
- K133035: Normed Pellegrin Calcaneus Stop Screw (2013), 2 descendants of its own
- K122738: Gaitway Implant System, Surgical Instrument Set (2012), 2 descendants of its own

## Indications for use
The Futura Biomedical Subtalar Peg 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 This device is intended to be fixed with bonc cement.

Source page: https://510kreport.com/device/K033046
Methodology: https://510kreport.com/methodology