# K160617: Large Screws Range

- Pathway: 510(k) (Traditional)
- Applicant: Newclip Technics
- Decided: Jun 3, 2016 after 92 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: 5 generations back to K962823 (1996). 12 ancestors in all.
6 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)
- K000080: Asnis Iii Cannulated Screw System, Howmedica Osteonics Corp. (2000) Summary page 4.
- K024060: Modification to Asnis Iii Cannulated Screw System, Howmedica Osteonics Corp. (2002) Summary page 4.
- K071639: Qwix Positioning Screw, Newdeal Sas (2007) Summary page 4.
- K050346: Stabilization Screw, New Deal, S.A. (2005) Summary page 4.

## Most influential descendants
- K172596: Large Screws Range (2017), 4 descendants of its own
- K173641: Activ Ankle (2018), 3 descendants of its own
- K261511: Xpert Ankle (2026), 0 descendants of its own
- K221395: Footmotion Plating System (2022), 0 descendants of its own
- K213214: Xpert Wrist (2021), 0 descendants of its own

## Indications for use
The Large Screws range is intended for the fixation of bone fractures, pseudarthroses, fusions and osteotomies of foot and ankle as well as medium and large bone fragments including radius, humerus, femur, tibia in adults.

Source page: https://510kreport.com/device/K160617
Methodology: https://510kreport.com/methodology