Cleared Traditional

K123814 - HUMELOCK II CEMENTED SHOULDER SYSTEM

K123814 is an FDA 510(k) clearance for HUMELOCK II CEMENTED SHOULDER SYSTEM, manufactured by Fx Solutions. The device is a Class 2 Orthopedic device with product code KWT cleared through the Traditional 510(k) pathway after a 244-day FDA review.

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.

View all Fx Solutions devices

FDA 510(k) Submission Details - K123814

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.

KWT Device Classification - Class 2, Special Controls

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 60
Devices cleared under the same product code (KWT) and FDA review panel - the closest regulatory comparables to K123814.
Exactech Equinoxe Humeral Reconstruction Prosthesis Extra-Small Proximal Bodies
K162903 · Exactech, Inc. · Feb 2017
SMR Shoulder System
K161476 · Lima Corporate S.P.A. · Jun 2016
Equinoxe Mega Prosthesis
K143659 · Exactech, Inc. · Apr 2015
ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM, BASE PLATES & HUMERAL STEMS
K121543 · Zimmer, Inc. · Oct 2012
COMPREHENSIVE SEGMENTAL REVISION SYSTEM (SRS)
K111746 · Biomet, Inc. · Dec 2011
BIGLIANI / FLATOW (R) THE COMPLETE SHOULDER SOLUTION
K110791 · Zimmer, Inc. · Sep 2011