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Glenoid Reconstruction System

by Medacta International S.A.

510(k) K213459

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK213459 Date23 Nov 2022ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
PHX
Device Class
Class II
Regulation
21 CFR Part 888.3660
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 28 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Glenoid Reconstruction System is a medical device used for glenoid deformities and defects in shoulder arthroplasty procedures. It includes a baseplate with a central screw option for additional fixation and stability. The system is part of the Medacta Shoulder System and can be enhanced with CT-based MyShoulder 3D preoperative planning.

The Glenoid Reconstruction System is supplied as part of the Medacta Shoulder System and is designed to improve procedural precision. It is compatible with the NextAR Shoulder integration. The device received FDA 510(k) clearance with the K number K213459 under product code PHX.

Other devices from Medacta International S.A.

See all devices from Medacta International S.A. →

Questions

AI-generated answers, 28 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Glenoid Reconstruction System used for?

    The Glenoid Reconstruction System is a medical device designed for treating glenoid deformities and defects in shoulder arthroplasty procedures. It includes a baseplate with a central screw option for additional fixation and stability.

  • How is the Glenoid Reconstruction System supplied?

    The Glenoid Reconstruction System is supplied as part of the Medacta Shoulder System and is designed to improve procedural precision. It is compatible with the NextAR Shoulder integration and can be enhanced with CT-based MyShoulder 3D preoperative planning.

  • What is the regulatory status of the Glenoid Reconstruction System?

    The Glenoid Reconstruction System received FDA 510(k) clearance with K number K213459 under product code PHX. It was determined to be substantially equivalent through the traditional clearance process.

  • Can the Glenoid Reconstruction System be used with other planning systems?

    Yes, the Glenoid Reconstruction System can be enhanced with CT-based MyShoulder 3D preoperative planning and is compatible with the NextAR Shoulder integration to improve procedural precision.