Skip to content

Distal Elbow Plating System

by Skeletal Dynamics, LLC 510(k)

Active United States

510(k) K140892

Overview

The Distal Elbow Plating System is a device intended for fixation of fractures, fusions, osteotomies, and non-unions of the radius and ulna. It consists of titanium alloy plates and screws, cobalt chrome cannulated polyaxial locking screws, k-wires, and specialized instrumentation designed for fracture fixation and internal joint stabilization in complex elbow trauma and instability.

The system is supplied as a set of implants and instruments for use in upper extremity surgery. It is indicated for use in the proximal ulna and distal elbow anatomy. The device received FDA 510(k) clearance under K140892 and is classified under product code HRS. It is manufactured by Skeletal Dynamics, LLC and is intended for use in surgical settings by trained medical professionals.

AI-generated from registry data, 25 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK140892 Date28 Aug 2014ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
HRS
Device Class
Class II
Regulation
21 CFR Part 888.3030
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Other devices from Skeletal Dynamics, Inc

See all devices from Skeletal Dynamics, Inc →

Questions

  • What is the Distal Elbow Plating System used for?

    The Distal Elbow Plating System is intended for fixation of fractures, fusions, osteotomies, and non-unions of the radius and ulna, specifically in the proximal ulna and distal elbow anatomy, to provide internal joint stabilization in complex elbow trauma and instability during upper extremity surgery.

  • What components are included in the Distal Elbow Plating System?

    The system consists of titanium alloy plates and screws, cobalt chrome cannulated polyaxial locking screws, k-wires, and specialized instrumentation designed for fracture fixation and internal joint stabilization in complex elbow trauma and instability.

  • How is the Distal Elbow Plating System supplied and who is it intended for?

    The system is supplied as a set of implants and instruments for use in upper extremity surgery and is intended for use by trained medical professionals in surgical settings.