# K160548: MC-Subtalar (TM) II

- Pathway: 510(k) (Traditional)
- Applicant: Merete Medical GmbH
- Decided: Apr 29, 2016 after 60 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: 8 generations back to K792670 (1980). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133035: Normed Pellegrin Calcaneus Stop Screw, Normed Medizin-Technik GmbH (2013) Summary page 4.

## Indications for use
The MC-Subtalar™ II screw system is for the correction of flexible flat feet in children (6 to < 12 years of age) and adolescence (12 to < 13 years of age). It is intended to block medial and plantar pronation of the talus, while, allowing normal subtalar joint motion. Specific indications for use include: Flexible flat feet in children and adolescence, Progression medial talus protrusion, Loss of longitudinal arch, Pain along the tibialis posterior, Age > 6 years, after conservative treatment did not result in a flat foot correction, Age < 13 years, while the deformity may be corrected manually.

Source page: https://510kreport.com/device/K160548
Methodology: https://510kreport.com/methodology