# K133035: Normed Pellegrin Calcaneus Stop Screw

- Pathway: 510(k) (Traditional)
- Applicant: Normed Medizin-Technik GmbH
- Decided: Dec 13, 2013 after 77 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: 7 generations back to K792670 (1980). 16 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111834: Disco Subtalar Implant, Trilliant Surgical, Ltd. (2011) Summary page 1.
- K033046: Subtalar Peg Implant, Nexa Orthopedics, Inc. (2003) Summary page 1.
- K014154: Vilex/Duval/Orthex Cannulated Bone Screw DB1 Thread, Model F25-XX-09; Vilex Solid Bone Screws DB1 Thread,Model F20-XX-00, Vilex, Inc. (2002) Summary page 2.

## Most influential descendants
- K160548: MC-Subtalar (TM) II (2016), 0 descendants of its own
- K140962: Normed Vario Subtalar Screw (2014), 0 descendants of its own

## Indications for use
Thte NormedS Pellegrin Calcaneus Stop Screw System is indicated for adult, children and adolescent patients. The screws ame intended to block forward, downward and medial displacement of the talus, thus allowing normal subtalarjoint motion but blocking excessive pmonation 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/K133035
Methodology: https://510kreport.com/methodology