# K160946: 4.0 and 6.5 Cancellous Bone Screw and Washer

- Pathway: 510(k) (Traditional)
- Applicant: Smv Scientific
- Decided: Dec 5, 2016 after 244 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: 10 generations back to K962616 (1996). 69 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 71 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111994: Smith & Nephew Cannulated Screws and Washers, Smith & Nephew, Inc. (2011) Summary page 5.
- K000089: Synthes 4.0 and 5.0 MM Locking Screws, Synthes (Usa) (2000) Summary page 5.
- K963192: Synthes Sterile 3.5 MM and 4.0 MM Cannulated Screws, Synthes (Usa) (1996) Summary page 5.
- K061621: Synthes (Usa) 6.5 MM Cancellous Screws, Synthes (Usa) (2006) Summary page 5.
- K052483: Synthes (Usa) Spherical Washers, Synthes (Usa) (2005) Summary page 5.

## Most influential descendants
- K260277: Mikron Trauma Bone Plate& Screw System (2026), 0 descendants of its own

## Indications for use
The 4.0 SMV Scientific Cancellous Bone Screw and Washer is intended for fixation of fractures with medium fragments, e.g.: – tarsal and metatarsal fractures and fixation in metatarsal and phalangeal osteotomies – tarsometatarsal and metatarsophalangeal arthrodeses – ligament fixations – hallux valgus corrections. Additionally, the 4.0 SMV Scientific Cancellous Screw and Washer is intended for arthrodesis and osteotomies of small bones and small joints, including scaphoid and other carpal bones, metacarpals, tarsals, metatarsals, patella, ulnar styloid, capitellum, radial head and radial styloid. The 6.5 SMV Scientific Cancellous Bone Screw and Washer is intended for fixation of fractures with large fragments, e.g.: – femoral neck fractures – intercondylar femoral fractures – epiphyseolysis of the femoral head – ankle arthrodeses. Additionally, the 6.5 SMV Scientific Cancellous Screw and Washer is intended for reconstruction, osteotomy, and arthrodesis of various bones and bone fragments appropriate for the size of the device including joint fusions (arthrodesis) in the foot and ankle.

Source page: https://510kreport.com/device/K160946
Methodology: https://510kreport.com/methodology