Cleared Traditional

AltiVate Reverse? ADLC Glenosphere

K252567 · Encore Medical, L.P. · Orthopedic

Jan 2026

Decision

154d

Days

Class 2

Risk

About This 510(k) Submission

K252567 is an FDA 510(k) clearance for the AltiVate Reverse? ADLC Glenosphere, a Shoulder Prosthesis, Reverse Configuration (Class II — Special Controls, product code PHX), submitted by Encore Medical, L.P. (Austin, US). The FDA issued a Cleared decision on January 15, 2026, 154 days after receiving the submission on August 14, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3660.

Submission Details

510(k) Number	K252567 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 14, 2025
Decision Date	January 15, 2026
Days to Decision	154 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	PHX — Shoulder Prosthesis, Reverse Configuration
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3660
Definition	Intended To Be Used To Relieve Pain And To Replace The Glenoid And Humeral Side Of The Shoulder Joint In Order To Restore Mobility In A Grossly Rotator Cuff Deficient Joint With Severe Arthropathy Or A Previous Joint Replacement With A Grossly Rotator Cuff Deficient Joint.