# K133451: Fixos Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Trauma AG
- Decided: Feb 28, 2014 after 108 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: 1 generation back to K000080 (2000). 3 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 7 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). Our reading of the summary gave K000050, FDA’s number for Top Quality Chlorinated-Powderfree Examination Gloves (Top Quality Mfg., Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Asnis III Cannulated Screw System”.
- K080850: Darco Headless Compression Screw, Wrightmedicaltechnologyinc (2008). Our reading of the summary gave K080550, FDA’s number for Megachannel Endoscopic Overtube, Model OT22 (Minos Medical). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Darco Headless Compression Screw”.
- K080943: Synthes 4.5 MM and 6.5 MM Headless Compression Screws, Synthes (Usa) (2008) Summary page 2.

## Most influential descendants
- K262075: Lapidus Screw Kit (2026), 0 descendants of its own
- K250935: TriMed Fifth Metatarsal System (Fifth Metatarsal Plate); TriMed Fifth Metatarsal System (Fifth Metatarsal Screw) (2025), 0 descendants of its own
- K223468: Nexis® compressive screws (2023), 0 descendants of its own

## Indications for use
The Stryker Fixes Screw System is a single use device intended for the fixation, correction or stabilization of small and long bones in adult and adolescent patients. Indications include: 04.0mm Headless Screw: * Fractures of the tarsals and metatarsals * Fractures of the olecranon, distal humerus * Fractures of the radius and ulna * Patella fractures * Distal tibia and pilon fractures * Fractures of the fibula, medial malleolus, os calcis * Tarso-metatarsal and metatarsophalangeal arthrodesis * Metatarsal and phalangeal osteotomies * Osteochondritis dissecans * Fractures of the pelvic ring * Small cancellous fragments of the small and long bones 05.0mm Headless Screw: * Medial and lateral malleolar and pilon fractures * Proximal and distal humerus fractures * Fractures of the olecranon process * Tibial plateau fractures * Os calcis, talar and patellar fractures * Fractures of the pelvis and acetabulum * Arthrodesis of the tarsals 07.0mm Headless Screw: * Tibia] plateau fractures * Ankle artbrodesis * Calcaneus osteotomies

Source page: https://510kreport.com/device/K133451
Methodology: https://510kreport.com/methodology