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Comprehensive Reverse Shoulder HA Glenosphere Baseplates

by Biomet Orthopedics

510(k) K252404

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 NumberK252404 Date15 Apr 2026ClearedStatusActive

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  • Withdrawn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, 19 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 Comprehensive Reverse Shoulder HA Glenosphere Baseplates are a type of shoulder prosthesis designed for reverse configuration arthroplasty. These devices are intended for use in primary, fracture, or revision reverse total shoulder replacement procedures, providing structural support for the glenoid component of the shoulder joint.

These baseplates are supplied sterile and intended for single-use. They are classified under product code PHX and have received FDA 510(k) clearance (K252404) for orthopedic use. The devices are engineered to accommodate HA (hydroxyapatite) coated glenospheres, ensuring compatibility with the Comprehensive Reverse Shoulder System. Storage and handling must adhere to sterile medical device protocols.

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