Cleared Traditional

Inset Reverse Total Shoulder System (K252221) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K252221 · Shoulder Innovations, Inc. · Orthopedic device
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Sep 2025
Decision
72d
Days
Class 2
Risk

K252221 is an FDA 510(k) clearance for the Inset Reverse Total Shoulder System. Classified as Shoulder Prosthesis, Reverse Configuration (product code PHX), Class II - Special Controls.

Submitted by Shoulder Innovations, Inc. (Grand Rapids, US). The FDA issued a Cleared decision on September 26, 2025 after a review of 72 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Shoulder Innovations, Inc. devices

Submission Details

510(k) Number K252221 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 2025
Decision Date September 26, 2025
Days to Decision 72 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
50d faster than avg
Panel avg: 122d · This submission: 72d
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 139
Devices cleared under the same product code (PHX) and FDA review panel - the closest regulatory comparables to K252221.
Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)
K252788 · Tornier, Inc. · Jan 2026
MSS - Humeral reverse liners extension
K250338 · Medacta International S.A. · Oct 2025
JARVIS Diaphyseal Stem Standard
K253345 · FH Industrie · Oct 2025
JARVIS Glenoid Reverse Shoulder Prosthesis
K252411 · FH Industrie · Aug 2025
AltiVate Reverse® Glenoid
K252141 · Encore Medical, L.P. · Aug 2025
Equinoxe® Shoulder System
K243448 · Exactech, Inc. · Aug 2025