Synthes 3.5 mm VA-LCP Proximal Tibia Plate System

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K120689 ↗

FDA Product Code

HRS

Device Class

Class II

Regulation

21 CFR Part 888.3030

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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See all devices from Synthes (USA) Products LLC →

• What is the Synthes 3.5 mm VA-LCP Proximal Tibia Plate System used for?

  This system is designed for the treatment of proximal tibia fractures in adults and adolescents who have fused growth plates. It enables surgeons to create a fixed-angle construct using variable angle locking screw technology while employing familiar conventional plating methods, providing stability and alignment during fracture healing.

• How is the Synthes 3.5 mm VA-LCP Proximal Tibia Plate System supplied and is it sterile or reusable?

  The device is supplied as part of the VA-LCP Periarticular Plating System in a 3.5-mm size and is provided as a non-sterile, reusable instrument system unless otherwise specified in the labeling. This means it must be cleaned and sterilized by the healthcare facility before each use, following established reprocessing protocols for reusable orthopedic instruments.

• What regulatory pathway was used for the Synthes 3.5 mm VA-LCP Proximal Tibia Plate System and when was it cleared?

  The system received FDA 510(k) clearance under submission number K120689 on June 4, 2012, and was determined to be substantially equivalent to a predicate device. It is classified under product code HRS, which pertains to internal fixation devices for bone fractures, and underwent a traditional 510(k) review process.