# K161665: VLP Wrist Fracture System

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Nov 15, 2016 after 152 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: 11 generations back to K962616 (1996). 46 ancestors in all.
10 later devices descend from it; 3 cite it directly.
0 of 57 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132296: D-Rad Smart Pack, Smith & Nephew, Inc. (2014) Summary page 4.
- K993106: Smith & Nephew Bone Plate System (Bone Plates, Bone Screws and Accessories), Smith & Nephew, Inc. (1999) Summary page 4.
- K043185: Synthes 3.5MM Cortex Screws, Synthes (Usa) (2005) Summary page 4.
- K082516: Peri-Loc Periarticular Locked Plating System Hexalobular Bone Screws, Smith & Nephew, Inc. (2008) Summary page 4.
- K083032: Peri-Loc Bone Plating and Screw System, Smith & Nephew, Inc. (2009) Summary page 4.
- K133939: Modified Distal Radius Plating System, Biomet (2014) Summary page 4.

## Most influential descendants
- K181533: EVOS Wrist Fracture Plating System (2018), 9 descendants of its own
- K210837: Smith & Nephew Plates and Screws (2021), 7 descendants of its own
- K213126: Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP Mini-Mod, Compression Hip Screw (CHS), CONQUEST FN, and cannulated screws (2022), 2 descendants of its own
- K233017: TM Plating System (2023), 1 descendant of its own
- K261207: Exalta Proximal Tibia Plating System (2026), 0 descendants of its own

## Indications for use
The VLP Wrist Fracture System Radial Plates are indicated for fixation of fractures, malunions, and ostcotomics involving the radius.

Source page: https://510kreport.com/device/K161665
Methodology: https://510kreport.com/methodology