# K140962: Normed Vario Subtalar Screw

- Pathway: 510(k) (Traditional)
- Applicant: Normed Nedizin Technik GmbH
- Decided: Jul 3, 2014 after 79 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). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 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 1.
- K093820: Subfix Arthroereisis Implant, Models SUT0065, SUT0080, SUT0090, SUT0100, SUT0115, Memometal Technologies (2010) Summary page 2.
- K111265: Metasurg Subtalar Implant, Metasurg (2011)

## Indications for use
The Vario Subtalar Screw System is indicated for adult, children and adolescent patients. The screws are 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. Adult - additive subtalar alignment for flat foot. Children - flexible flat foot treatment in children and adolescents.

Source page: https://510kreport.com/device/K140962
Methodology: https://510kreport.com/methodology