# K160603: SMV Scientific Schanz Screws

- Pathway: 510(k) (Traditional)
- Applicant: Smv Scientific
- Decided: Mar 28, 2016 after 26 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: 1 generation back to K040701 (2004). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040701: Synthes (Usa) Hydroxyapatite (HA) Coated Schanz Screws, Synthes (Usa) (2004) Summary page 4.

## Indications for use
The SMV Scientific Schanz Screws are intended for use as external fixation for fracture fixation (open and closed); pseudoarthrosis or non-union of long bones; limb lengthening by epiphyseal or metaphyseal distraction; correction of bony or soft tissue deformity; correction of segmental bony or soft tissue defects; and joint arthrodesis.

Source page: https://510kreport.com/device/K160603
Methodology: https://510kreport.com/methodology