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ALIGN Radial Head System

by Skeletal Dynamics, Inc. 510(k)

Active United States

510(k) K231188

Overview

The ALIGN Radial Head System is a prosthesis, elbow, hemi-, radial, polymer device intended for use in upper extremity surgery to restore radial head anatomy and optimize elbow stability. It is a monoblock implant that mimics the patient's natural anatomy and includes precision-engineered titanium alloy implants, cobalt-chrome modular components, cannulated instrumentation, and specialized tools for precise radial head reconstruction.

The device is supplied as a system for surgical use in clinical settings. It is authorized under FDA 510(k) clearance (K231188) and is classified as a Class II medical device under regulation number 888.3170. The system is provided non-sterile and requires sterilization prior to use; it is intended for single-use implantation. Sizes and specific storage conditions are not detailed in the provided data.

AI-generated from registry data, 28 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 NumberK231188 Date28 Sep 2023ClearedStatusActive

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
KWI
Device Class
Class II
Regulation
21 CFR Part 888.3170
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the ALIGN Radial Head System used for?

    The ALIGN Radial Head System is intended for use in upper extremity surgery to restore radial head anatomy and optimize elbow stability. It functions as a hemi-radial prosthesis made of polymer material, designed to mimic the patient's natural anatomy during radial head reconstruction.

  • How is the ALIGN Radial Head System supplied and prepared for use?

    The device is supplied as a non-sterile system for surgical use in clinical settings. It requires sterilization prior to implantation and is intended for single-use only, meaning it should not be reprocessed or reused after implantation.

  • What components are included in the ALIGN Radial Head System?

    The system includes precision-engineered titanium alloy implants, cobalt-chrome modular components, cannulated instrumentation, and specialized tools for precise radial head reconstruction. It is a monoblock implant designed to mimic natural anatomy.