Cleared Traditional

HUMELOCK CEMENTED SHOULDER PROSTHESIS (K111097) - FDA 510(k) Clearance

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

K111097 · Fx Solutions · Orthopedic device
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Nov 2011
Decision
203d
Days
Class 2
Risk

K111097 is an FDA 510(k) clearance for the HUMELOCK CEMENTED SHOULDER PROSTHESIS. Classified as Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented (product code HSD), Class II - Special Controls.

Submitted by Fx Solutions (Viriat, FR). The FDA issued a Cleared decision on November 9, 2011 after a review of 203 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3690 - 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

Submission Details

510(k) Number K111097 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 2011
Decision Date November 09, 2011
Days to Decision 203 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
81d slower than avg
Panel avg: 122d · This submission: 203d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3690
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 - HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

All 33
Devices cleared under the same product code (HSD) and FDA review panel - the closest regulatory comparables to K111097.
EXACTECH EQUINOXE RESURFACING HUMERAL HEAD SYSTEM
K131298 · Exactech, Inc. · Nov 2013
ARTHREX UNIVERS II CA HEADS
K130675 · Arthrex, Inc. · Oct 2013
SMITH & NEPHEW, INC. SHOULDER SYSTEM INSTRUMENTS
K121714 · Smith & Nephew, Inc. · Sep 2012
DEPUY GLOBAL AP CTA HUMERAL HEAD
K082715 · DePuy Orthopaedics, Inc. · Dec 2008
DEPUY GLOBAL C.AP. CTA RESURFACING SHOULDER
K080990 · DePuy Orthopaedics, Inc. · Aug 2008
SYNTHES (USA) EPOCA SHOULDER PROSTHESIS SYSTEM
K072578 · Synthes (Usa) · Nov 2007