# K090675: Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Jun 4, 2009 after 83 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K962616 (1996). 45 ancestors in all.
487 later devices descend from it; 23 cite it directly.
1 of 533 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060736: Smith & Nephew 6.5MM and 8.0MM Cannulated Screws, Smith & Nephew, Inc. (2006) Summary page 2.
- K012945: Synthes 2.4 MM Cannulated Screw, Synthes (Usa) (2001)
- K962823: Synthes Sterile 3.0 MM Cannulated Screw and Threaded Washer, Synthes (Usa) (1996) Summary page 2.
- K050636: Synthes 3.0MM Headless Compression Screws, Synthes (Usa) (2005) Summary page 2.
- K062352: FRS Screw, DePuy Orthopaedics, Inc. (2006) Summary page 2.
- K071563: Peri-Loc Periarticular Locked Plating System, Smith & Nephew, Inc. (2007) Summary page 2.
- K033669: Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws), Smith & Nephew, Inc. (2003) Summary page 2.
- (no number) Smith & Nephew K-Wires: named in the summary without a submission number

## Most influential descendants
- 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
- K143039: CrossRoads Screw System (2015), 79 descendants of its own
- K120070: Synthes Variable Angle LCP Elbow System (2012), 76 descendants of its own

## Indications for use
The VLP FOOT Plating, Screw System and Accessories is indicated for the following: The Smith & Nephew VLP FOOT Plating System can be used in adolescent (12-18 years) and transitional adolescent (18-21 years) subpopulations and adults, as well as patients with osteopenic bone. The VLP FOOT Plating System is indicated for the treatment of fracture fixation, reconstruction or arthrodeses of small bones, including those in the forefoot, midfoot and hindfoot. The Smith & Nephew 2.5mm, 3.0mm Cannutated and 3.0mm Headless Compression Screws are intended for fixation of intraarticular and extra-articular fractures and non-unions of small bones and small bone fragments; arthrodeses of small joints; bunionectomies and osteotomies; scaphoid and other carpal bones, metacarpals, tarsals, metatarsals, patella, ulnar styloid, capitellum, radial head and radial styloid. The Smith & Nephew 2.0mm QFX Screw is indicated for osteotomies of the lesser metatarsals, such as Weil osteotomies. Osteotomies, fusions and fractures of the phalanges, metacarpals and carpals of the hand. Pins and wires are indicated for pelvic, small and long bone fracture fixation.

Source page: https://510kreport.com/device/K090675
Methodology: https://510kreport.com/methodology