# K051605: Sbi K-Wires

- Pathway: 510(k) (Traditional)
- Applicant: Small Bone Innovations, LLC
- Decided: Aug 10, 2005 after 55 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.
27 later devices descend from it; 6 cite it directly.
0 of 28 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
- K120787: Merete Locking Bone Plate System Iii (2012), 12 descendants of its own
- K133691: Extrimilock Ankle Plating System (2014), 10 descendants of its own
- K112727: Medical Facets Corical Screws, Medical Facets Cancellous Screws, Medical Facets Headless Compression Screws, Medical (2012), 9 descendants of its own
- K160191: Align Anterior Ankle Fusion Plate (2016), 5 descendants of its own
- K132820: Vilex Ultima External Fixation System with HA Coated Pins and Wires (2014), 5 descendants of its own

## Indications for use
The SBI K-Wires are indicated for use in fixation of bone fractures, for bone reconstruction, and as guide pins for insertion of other implants.

Source page: https://510kreport.com/device/K051605
Methodology: https://510kreport.com/methodology