# K080280: Sub-Talar Lok, Model 7-11 MM

- Pathway: 510(k) (Traditional)
- Applicant: Instratek, Inc.
- Decided: Mar 14, 2008 after 39 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.
12 later devices descend from it; 5 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032902: Subtalar Arthrorisis Implant, Nexa Orthopedics, Inc. (2003) Summary page 1.
- K031155: Osteomed Subtalar Implant System, Osteomed LP (2003) Summary page 1.

## 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 Instratek Sub-Talar Lok arthroereisis implant restricts excessive subtalar pronation in all three planes, providing for a more normal subtalar joint motion in patients. The Sub-Talar Lok is intended for the following pathological conditions resulting from disease, injury, or other trauma. Hypermobile pes valgus Posterior tibial tendon dysfunction Severe pronation Subtalar instability Hypermobile flexible congenital flat foot

Source page: https://510kreport.com/device/K080280
Methodology: https://510kreport.com/methodology