Cleared Traditional

K252567 - AltiVate Reverse ADLC Glenosphere

K252567 is the FDA 510(k) clearance for AltiVate Reverse ADLC Glenosphere by Encore Medical, L.P.. It is a Class 2 Orthopedic device (product code PHX) cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K252567 · Encore Medical, L.P. · Orthopedic device
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Jan 2026
Decision
154d
Days
Class 2
Risk

K252567 is an FDA 510(k) clearance for the AltiVate Reverse® ADLC Glenosphere. Classified as Shoulder Prosthesis, Reverse Configuration (product code PHX), Class II - Special Controls.

Submitted by Encore Medical, L.P. (Austin, US). The FDA issued a Cleared decision on January 15, 2026 after a review of 154 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3660 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Encore Medical, L.P. devices

Submission Details

510(k) Number K252567 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d slower than avg
Panel avg: 122d · This submission: 154d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PHX Shoulder Prosthesis, Reverse Configuration
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - PHX Shoulder Prosthesis, Reverse Configuration

All 178
Devices cleared under the same product code (PHX) and FDA review panel - the closest regulatory comparables to K252567.
MSS - Monobloc stem
K250644 · Medacta International S.A. · Feb 2026
SMR Shoulder System
K252352 · Lima Corporate S.P.A. · Jan 2026
N22 EZ Glenosphere
K252516 · Shoulder Innovations, Inc. · Jan 2026
JARVIS Metaphyseal Stem
K254003 · FH Industrie · Jan 2026
Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)
K252788 · Tornier, Inc. · Jan 2026
MSS - Humeral reverse liners extension
K250338 · Medacta International S.A. · Oct 2025