# K150188: SMV Scientific 4.5 mm Bone Screws

- Pathway: 510(k) (Traditional)
- Applicant: Summit Medventures
- Decided: Apr 29, 2015 after 92 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: 2 generations back to K983495 (1998). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092889: Syntec Osteo-Plate and Screw Fixation, Syntec Scientific Corp. (2010) Summary page 5.

## Indications for use
The SMV Scientific 4.5mm Bone Screws are intended to treat fractures of various bones including the clavicle, scapula, pelvis, long bones (humerus, ulna, radius, femur, tibia, and fibula), and small bones (metacarpals, metatarsals, and phalanges).

Source page: https://510kreport.com/device/K150188
Methodology: https://510kreport.com/methodology