# K132886: Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Feb 4, 2014 after 141 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K962616 (1996). 68 ancestors in all.
46 later devices descend from it; 9 cite it directly.
0 of 115 devices in its family (counting itself) have 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 2.
- K090675: Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories, Smith & Nephew, Inc. (2009) Summary page 2.
- K083032: Peri-Loc Bone Plating and Screw System, Smith & Nephew, Inc. (2009) Summary page 2.
- K060736: Smith & Nephew 6.5MM and 8.0MM Cannulated Screws, Smith & Nephew, Inc. (2006) Summary page 2.
- K062216: Peri-Loc Periarticular Locked Plating System, Smith & Nephew, Inc. (2006) Summary page 2.
- K063049: Synthes (Usa) Modular Mini Fragment LCP System, Synthes (Usa) (2006) Summary page 2.
- K051567: Aptus Titanium Osteosynthesis System, Medartis, Inc. (2005) Summary page 2.
- K101240: Closed Fusion Plate, MTP Plate, Talus Plate, Model 824077021, 22; 824677021, 22, 824071001, 824071101, 824671001, 82467, DePuy Orthopaedics, Inc. (2010) Summary page 2.
- K061748: Fragment Plate System, Hand Innovations, LLC (2006) Summary page 2.

## Most influential descendants
- K140814: Evos Mini-Fragment Plating System (2014), 32 descendants of its own
- K163361: ANTHEM™ Fracture System (2017), 14 descendants of its own
- K173166: ANTHEM Fracture System (2017), 11 descendants of its own
- K191412: VariAx 2 System, VariAx 2 Mini Fragment System (2019), 10 descendants of its own
- K180554: ANTHEM Fracture System (2018), 10 descendants of its own

## Recalls of this device
- Dec 11, 2017 · Class II · Z-0396-2018: Devices, incorrectly labeled as a VLP MINI-MOD 2.0MM STRAIGHT PLATE 8 HOLE, contained a VLP MINI-MOD 2.0MM STOUT PLATE 8 HOLE and vice versa
- Dec 11, 2017 · Class II · Z-0397-2018: Devices, incorrectly labeled as a VLP MINI-MOD 2.0MM STRAIGHT PLATE 8 HOLE, contained a VLP MINI-MOD 2.0MM STOUT PLATE 8 HOLE and vice versa

## Indications for use
The Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System is indicated for adolescent (12-18 years) and transitional adolescent (18-21 years) subpopulations and adults, as well as patients with osteopenic bone. The Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System is indicated for fracture fixation, arthrodesis, reconstruction, replantation or reduction of small bones and small bone fragments. This system is also indicated for non-load bearing stabilization and reduction of bone fragments in long bones; Components in the Smith & Nephew Variable-Angle Locking Mini-Fragment Plating Systenif are for single use only.

Source page: https://510kreport.com/device/K132886
Methodology: https://510kreport.com/methodology