Cleared Traditional

K241944 - AGILON® XO Shoulder Replacement System (FDA 510(k) Clearance)

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

K241944 · Implantcast GmbH · Orthopedic device
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Mar 2025
Decision
251d
Days
Class 2
Risk

K241944 is an FDA 510(k) clearance for the AGILON® XO Shoulder Replacement System. Classified as Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented (product code KWT), Class II - Special Controls.

Submitted by Implantcast GmbH (Buxtehude, DE). The FDA issued a Cleared decision on March 10, 2025 after a review of 251 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3650 - 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 Implantcast GmbH devices

Submission Details

510(k) Number K241944 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2024
Decision Date March 10, 2025
Days to Decision 251 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
129d slower than avg
Panel avg: 122d · This submission: 251d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KWT Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3650
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 Consultant

Mcra, LLC
Sarah Pleaugh

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - KWT Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented

All 70
Devices cleared under the same product code (KWT) and FDA review panel - the closest regulatory comparables to K241944.
Equinoxe® Humeral Reconstruction Prosthesis
K250713 · Exactech, Inc. · Dec 2025
Tornier Humeral Reconstruction System Max (Tornier HRS Max)
K251686 · Tornier, Inc. · Oct 2025
InSet Total Shoulder System
K241817 · Shoulder Innovations, Inc. · Feb 2025
AGILON® XO Shoulder Replacement System
K231657 · Implantcast GmbH · Feb 2024
LINK Embrace Shoulder System- Anatomical Configuration
K210899 · Waldemar Link GmbH & Co. KG · Jun 2021