# K111994: Smith & Nephew Cannulated Screws and Washers

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Oct 11, 2011 after 90 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: 9 generations back to K962616 (1996). 65 ancestors in all.
161 later devices descend from it; 16 cite it directly.
1 of 227 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090675: Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories, Smith & Nephew, Inc. (2009) Summary page 3.
- K080943: Synthes 4.5 MM and 6.5 MM Headless Compression Screws, Synthes (Usa) (2008) Summary page 3.
- K063298: Osteomed Headless Cannulated Screw System, Osteomed LP (2007) Summary page 3.
- K102903: Pioneer Cannulated Screw System, Pioneer Surgical Technology, Inc. (2010) Summary page 3.
- K021932: Synthes 6.5 MM Cannulated Screw, Synthes (Usa) (2002) Summary page 3.
- K052483: Synthes (Usa) Spherical Washers, Synthes (Usa) (2005) Summary page 3.
- K003496: Cannulated Screw System, Pioneer Surgical Technology (2001) Summary page 3.

## Most influential descendants
- K143039: CrossRoads Screw System (2015), 79 descendants of its own
- K162825: CAPTIVATE™ Compression Screws (2017), 74 descendants of its own
- K171651: Excelsius GPS (2017), 69 descendants of its own
- K191100: ExcelsiusGPS Spine 1.1 Interbody Module (2019), 42 descendants of its own
- K124027: Monster Screw System (2013), 41 descendants of its own

## Indications for use
Bone plates and screws from the Smith and Nephew Bone Plate System are used for adult and pediatric patients as indicated for pelvic, small, and long bone fracture fixation. Indications for use include, fractures of the tibia, fibula, femoral condyle, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, middle hand and middle foot bones; treatment of the calcaneus; hip arthrodesis, and provisional hole fixation. The 4.0mm Cannulated Screws and associated washers are additionally 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 5.5mm, 6.5mm, 7.0mm, and 8.0mm Cannulated Screws and associated washers are additionally 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/K111994
Methodology: https://510kreport.com/methodology