# K122489: Emerge Medical Solid Bone Screws

- Pathway: 510(k) (Traditional)
- Applicant: Emerge Medical
- Decided: Dec 10, 2012 after 117 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: 11 generations back to K962616 (1996). 87 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 89 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112583: Synthes Cortical Screws, Synthes (USA) Products, LLC (2011) Summary page 1.
- K061621: Synthes (Usa) 6.5 MM Cancellous Screws, Synthes (Usa) (2006) Summary page 1.

## Most influential descendants
- K141347: Emerge Medical IM Nail System (2014), 0 descendants of its own

## Indications for use
The Emerge Solid Bone Screws are intended to provide bone fixation in the management Of osteotomnies, fusions, and fractures of metaphysis and diaphysis of both small and large bones and the pelvis. The screws may be used alone or with washers.

Source page: https://510kreport.com/device/K122489
Methodology: https://510kreport.com/methodology