# K131186: Synthes 2.7MM and 3.5MM Variable Angle LCP Midfoot/Hindfoot System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (USA) Products, LLC
- Decided: Oct 8, 2013 after 166 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: 7 generations back to K000684 (2000). 34 ancestors in all.
8 later devices descend from it; 4 cite it directly.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111230: Synthes 3.5MM Low Profile Cortical Screw, Synthes (USA) Products, LLC (2011)
- K103705: Low Profile Screws, Arthrex, Inc. (2011) Summary page 1.
- K991407: Synthes Locking Calcaneal Plates, Synthes (Usa) (1999) Summary page 1.
- K071264: Synthes (Usa) 2.4/2.7 MM Locking Foot Module, Synthes (Usa) (2007) Summary page 1.
- K063875: Stryker Foot Plating System, Howmedica Osteonics Corp. (2007) Summary page 1.

## Cited in the summary but kept off the family tree
- K012583: Acuglide Brand Acupuncture Needles, Helio Medical Supplies, Inc. (2001). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K100776: Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System, Synthes (Usa) (2010). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K233665: DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment Plating System (2024), 4 descendants of its own
- K254093: DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating System (2026), 0 descendants of its own
- K260069: DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating System (2026), 0 descendants of its own
- K252191: BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus System (2025), 0 descendants of its own
- K251361: Tyber Medical Distal Radius Plating System (2025), 0 descendants of its own

## Indications for use
The Synthes 2.7 and 3.5 mm Variable Angle LCP Midfoot/Hindfoot System is indicated for fixation of osteotomies, fusions, fractures, nonunions, malunions and replantations of small bones and small bone fragments in adult and adolescent (12-21 years) patients, including the foot and ankle, and particularly in osteopenic bone. The Synthes 3.5mm Low Profile Cortical Screws are intended to be used as stand-alone bone screws, or in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, hand, radius, ulna, pelvis, tibia, femur, fibula, and foot in adults, and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by the screw fixation. The Synthes 3.5mm Cortex Screws are intended to be used as stand-alone bone screws, or in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, hand, radius, ulna, pelvis, tibia, femur, fibula, and foot in adults, and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by the screw fixation.

Source page: https://510kreport.com/device/K131186
Methodology: https://510kreport.com/methodology