# K151456: Small Bone Nail Implant

- Pathway: 510(k) (Traditional)
- Applicant: Vilex IN Tennessee, Inc.
- Decided: Oct 29, 2015 after 150 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K000684 (2000). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031438: Acumed Small Bone Locking Rod System II, Acumed, LLC (2003) Summary page 4.
- K071944: Acumed Small Bone Locking System II, Acumed, LLC (2007) Summary page 4.
- K982953: Titanium Intramedullary Nails-Various Styles, Biomet, Inc. (1998) Summary page 4.
- K854338: Kirschner Intramedullary Nail System, Kirschner Medical Corp. (1985) Summary page 4.
- K973812: Arthrex Puddu Osteotomy System, Arthrex, Inc. (1998) Summary page 4.
- K052614: Low Profile Plate and Screw System, Arthrex, Inc. (2005) Summary page 4.

## Indications for use
The Tapered Small Bone Nail Implant (SBNI) is indicated for use in fractures and osteotomies of the fibula, radius, and ulna.

Source page: https://510kreport.com/device/K151456
Methodology: https://510kreport.com/methodology