# K060736: Smith & Nephew 6.5MM and 8.0MM Cannulated Screws

- Pathway: 510(k) (Special)
- Applicant: Smith & Nephew, Inc.
- Decided: Apr 18, 2006 after 29 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K903810 (1990). 5 ancestors in all.
531 later devices descend from it; 10 cite it directly.
1 of 537 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993106: Smith & Nephew Bone Plate System (Bone Plates, Bone Screws and Accessories), Smith & Nephew, Inc. (1999) Summary page 1.
- K903810: Ace Cannulated Self Tapping Cancellous Bone Screw, Ace Medical Co. (1990) Summary page 1.
- K000080: Asnis Iii Cannulated Screw System, Howmedica Osteonics Corp. (2000) Summary page 1.
- K051296: Sijf Cannulated Screw System, Depuy Spine, Inc. (2005). Our reading of the summary gave K001296, FDA’s number for Spinal Cord and Immobilization Traction System (Cavendish Scott, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “DePuy Spine Inc. SIJF Cannulated Screw System”.

## Most influential descendants
- K090675: Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories (2009), 487 descendants of its own
- K100776: Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System (2010), 228 descendants of its own
- K111994: Smith & Nephew Cannulated Screws and Washers (2011), 161 descendants of its own
- K112583: Synthes Cortical Screws (2011), 118 descendants of its own
- K072818: Peri-Loc Periartricular LCK Pit Sys-Prox Fem Plates/Screws.Calbe Access (2007), 93 descendants of its own

## Recalls of this device
- Sep 20, 2021 · Class II · Z-0143-2022: The product label incorrectly indicated that the screws are fully threaded, but the screws contained in the package were partially threaded.

## Indications for use
The Smith & Nephew Bone Plate System is 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 calcaneal; hip arthrodesis, and provisional bone fixation. Smith & Nephew 6.5mm and 8.0mm Cannulated Screws are for single use only

Source page: https://510kreport.com/device/K060736
Methodology: https://510kreport.com/methodology