Cleared Traditional

K252129 - AETOS Shoulder System Stemless Humeral Prosthesis (FDA 510(k) Clearance)

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

K252129 · Smith & Nephew, Inc. · Orthopedic device
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Oct 2025
Decision
88d
Days
Class 2
Risk

K252129 is an FDA 510(k) clearance for the AETOS Shoulder System Stemless Humeral Prosthesis. Classified as Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-constrained (product code PKC), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Cordova, US). The FDA issued a Cleared decision on October 3, 2025 after a review of 88 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 Smith & Nephew, Inc. devices

Submission Details

510(k) Number K252129 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 2025
Decision Date October 03, 2025
Days to Decision 88 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
34d faster than avg
Panel avg: 122d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PKC Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-constrained
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3660
Definition Replacement Of The Humeral Head For Total Anatomic Shoulder Arthroplasty
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 - PKC Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-constrained

All 18
Devices cleared under the same product code (PKC) and FDA review panel - the closest regulatory comparables to K252129.
FX V135 EASYTECH® Shoulder System
K254154 · FX Shoulder Solutions, Inc. · May 2026
INHANCE INTACT™
K243248 · Depuy Ireland UC · Dec 2024
OsseoFit Stemless Shoulder System
K241873 · Zimmer, Inc. · Dec 2024
AETOS Shoulder System Stemless Humeral Prosthesis
K240716 · Smith & Nephew, Inc. · Nov 2024
SMR Stemless Anatomic
K221758 · Lima Corporate S.P.A. · Mar 2023
Tornier Perform Humeral System – Stemless
K220418 · Tornier, Inc. · Sep 2022