Cleared Traditional

K111097 - HUMELOCK CEMENTED SHOULDER PROSTHESIS

K111097 is an FDA 510(k) clearance for HUMELOCK CEMENTED SHOULDER PROSTHESIS, manufactured by Fx Solutions. The device is a Class 2 Orthopedic device with product code HSD cleared through the Traditional 510(k) pathway after a 203-day FDA review.

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

FDA 510(k) Submission Details - K111097

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.

HSD Device Classification - Class 2, Special Controls

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 58
Devices cleared under the same product code (HSD) and FDA review panel - the closest regulatory comparables to K111097.
ARTHREX UNIVERS II CA HEADS
K130675 · Arthrex, Inc. · Oct 2013
SMITH & NEPHEW, INC. SHOULDER SYSTEM INSTRUMENTS
K121714 · Smith & Nephew, Inc. · Sep 2012
SMR RESURFACING SHOULDER SYSTEM- HUMERAL HEADS, CTA HUMERAL HEADS
K112900 · Lima Corporate S.P.A. · Jun 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