# K170021: SMV Scientific Cannulated Screws

- Pathway: 510(k) (Traditional)
- Applicant: Smv Scientific
- Decided: May 22, 2017 after 139 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 K962011 (1996). 6 ancestors in all.
8 later devices descend from it; 4 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012945: Synthes 2.4 MM Cannulated Screw, Synthes (Usa) (2001) Summary page 5.
- K962823: Synthes Sterile 3.0 MM Cannulated Screw and Threaded Washer, Synthes (Usa) (1996) Summary page 5.
- K963192: Synthes Sterile 3.5 MM and 4.0 MM Cannulated Screws, Synthes (Usa) (1996) Summary page 5.
- K963172: Synthes Sterile 4.5 MM Cannulated Screws, Synthes (Usa) (1996) Summary page 5.
- K962011: Synthes 7.0/7.3 MM Cannulated Screws, Synthes (Usa) (1996) Summary page 5.
- K021932: Synthes 6.5 MM Cannulated Screw, Synthes (Usa) (2002) Summary page 5.

## Most influential descendants
- K210754: Cannulated Fasteners and Nuts (2021), 3 descendants of its own
- K211783: TriMed Threaded Intramedullary Nail System (2021), 2 descendants of its own
- K211290: Cannulated Fasteners and Nuts (2021), 2 descendants of its own
- K230749: TriMed Threaded Intramedullary Nail System (2023), 1 descendant of its own
- K242691: OsteoCentric Technologies Cannulated Fasteners and Nuts (2024), 0 descendants of its own

## Indications for use
The SMV Scientific 2.4mm and 3.0mm Cannulated Screws are intended for fixation of fractures and non-unions of small bones and small bone arthrodesis. Examples include, but are not limited to scaphoid and other carpal fractures, metacarpal and phalangeal fusions, osteotomies, and bunionectomies. The SMV Scientific 3.5mm Cannulated Screws are intended for fixation of small bones and small bone fragments, such as fractures of the metatarsals, arthrodeses of the carpals and phalanges, steochondritis dissecans, and ligament fixation. The SMV Scientific 4.5mm Cannulated Screws is intended for fracture fixation of long bones and long bone fragments. The SMV Scientific 6.5mm and 7.3mm Cannulated Screws are intended for fracture fixation of large bones and large bone fragments, femoral neck fractures, slipped capital femoral epiphyses, as an adjunct to DHS in basilar neck fractures, tibial plateau fractures, ankle arthrodesis, pediatric femoral neck fractures, intercondylar femur fractures, and subtalar arthrodesis.

Source page: https://510kreport.com/device/K170021
Methodology: https://510kreport.com/methodology