Synthes LCP Ankle Arthrodesis Plates

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

510(k) Number

K061940 ↗

FDA Product Code

HRS

Device Class

Class II

Regulation

21 CFR Part 888.3030

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Synthes Light Guide

  Class II

  FDA 510(k) K993314 Active Cleared 6 Dec 1999

• Synthes Locking Hand Plates

  Class II

  FDA 510(k) K092247 Active Cleared 25 Sep 2009

• Synthes Matrix Mis Rods

  Class II

  FDA 510(k) K093668 Active Cleared 9 Mar 2010

• Synthes Lcp Proximal Tibia Plate

  Class II

  FDA 510(k) K011978 Active Cleared 9 Aug 2001

• Synthes Locking Calcaneal Plates

  Class II

  FDA 510(k) K991407 Active Cleared 11 Jun 1999

• Volar Distal Radius Plate

  Class II

  FDA 510(k) K953644 Active Cleared 8 Mar 1996

See all devices from Synthes (Usa) →

• What is the Synthes LCP Ankle Arthrodesis Plate used for?

  The Synthes LCP Ankle Arthrodesis Plate is used to promote fusion (arthrodesis) of the ankle joint and distal tibia in orthopedic surgical procedures, stabilizing bone through its minimally contoured metal plate design and locking screw technology.

• How is the Synthes LCP Ankle Arthrodesis Plate supplied and sterilized?

  The device is supplied by Synthes (USA) as a metallic bone fixation implant; however, the provided data does not specify sterility status or whether it is single-use or reusable, so users must consult the product labeling for sterilization and usage instructions.

• What regulatory pathway was used for the Synthes LCP Ankle Arthrodesis Plate?

  The Synthes LCP Ankle Arthrodesis Plate received FDA 510(k) clearance under K061940, was determined to be substantially equivalent to a predicate device, and is classified under product code HRS for orthopedic devices.