# K083490: Biopro K-Wire, Models 16863, 17231, 17232, 18577, 18682-18685

- Pathway: 510(k) (Traditional)
- Applicant: Biopro, Inc.
- Decided: Mar 18, 2009 after 113 days
- Product code: HTY (Pin, Fixation, Smooth)
- 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.
10 later devices descend from it; 2 cite it directly.
0 of 11 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 no predicate by number.

## Most influential descendants
- K110895: Ortho Solutions Trauma Implants for Osteosynthesis (2011), 8 descendants of its own
- K163489: OrthoSolutions 'System26' Bone Screws (2017), 3 descendants of its own
- K150889: Suture Wires and Wire Loops (2015), 2 descendants of its own
- K203773: BRM TOOL Screws (2022), 1 descendant of its own
- K151848: Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle System (2016), 1 descendant of its own

## Indications for use
The BioPro K-Wire is indicated for use in fixation of bone fractures, for bone reconstructions, and as guide pins for insertion of other implants or implantation through the skin so that traction may be applied to the skeletal system.

Source page: https://510kreport.com/device/K083490
Methodology: https://510kreport.com/methodology