# K053136: 5TH Metatarsal Fracture Screw

- Pathway: 510(k) (Traditional)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Jan 5, 2006 after 57 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
No predicates in its family tree.
41 later devices descend from it; 4 cite it directly.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Multi-Use Compression Screw: named in the summary without a submission number

## Most influential descendants
- K140741: Salvation Beams and Bolts System (2014), 34 descendants of its own
- K171018: Axis Charcot Fixation System, 4.5 to 8.5mm Screw System (2017), 24 descendants of its own
- K190586: Monster® Screw System (2019), 21 descendants of its own
- K200398: AxSOS 3 AF System and AxSOS 3 Ti System (2020), 9 descendants of its own
- K222381: PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating System (2023), 8 descendants of its own

## Indications for use
The 5th Metatarsal Fracture Screw is indicated for fixation of bone fractures or for bone reconstruction of the 5th Metatarsal. Examples include: * Fixation of malunions and nonunions * Acute fractures * Avulsion fractures * Repetitive stress fractures * Jones Fractures * Malleolar Fractures * Talus Fractures * Greater Tuberosity Fractures

Source page: https://510kreport.com/device/K053136
Methodology: https://510kreport.com/methodology