Cleared Traditional

K123814 - HUMELOCK II CEMENTED SHOULDER SYSTEM (FDA 510(k) Clearance)

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

K123814 · Fx Solutions · Orthopedic device
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Aug 2013
Decision
244d
Days
Class 2
Risk

K123814 is an FDA 510(k) clearance for the HUMELOCK II CEMENTED SHOULDER SYSTEM. Classified as Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented (product code KWT), Class II - Special Controls.

Submitted by Fx Solutions (Viriat, FR). The FDA issued a Cleared decision on August 13, 2013 after a review of 244 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.

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Submission Details

510(k) Number K123814 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 2012
Decision Date August 13, 2013
Days to Decision 244 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
122d slower than avg
Panel avg: 122d · This submission: 244d
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 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 K123814.
Equinoxe® Humeral Reconstruction Prosthesis
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Tornier Humeral Reconstruction System Max (Tornier HRS Max)
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AGILON® XO Shoulder Replacement System
K241944 · Implantcast GmbH · Mar 2025
InSet Total Shoulder System
K241817 · Shoulder Innovations, Inc. · Feb 2025
AGILON® XO Shoulder Replacement System
K231657 · Implantcast GmbH · Feb 2024
Comprehensive Segmental Revision System(SRS)
K223631 · Biomet Orthopedics · Jul 2023