Cleared Traditional

K130675 - ARTHREX UNIVERS II CA HEADS

K130675 is the FDA 510(k) clearance for ARTHREX UNIVERS II CA HEADS by Arthrex, Inc.. It is a Class 2 Orthopedic device (product code HSD) cleared through the Traditional 510(k) pathway after a 231-day FDA review.

K130675 · Arthrex, Inc. · Orthopedic device
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Oct 2013
Decision
231d
Days
Class 2
Risk

K130675 is an FDA 510(k) clearance for the ARTHREX UNIVERS II CA HEADS. Classified as Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented (product code HSD), Class II - Special Controls.

Submitted by Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on October 30, 2013 after a review of 231 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 Arthrex, Inc. devices

Submission Details

510(k) Number K130675 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 2013
Decision Date October 30, 2013
Days to Decision 231 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
109d slower than avg
Panel avg: 122d · This submission: 231d
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 48
Devices cleared under the same product code (HSD) and FDA review panel - the closest regulatory comparables to K130675.
Anatomical Shoulder Domelock Dome centric
K161620 · Zimmer GmbH · Nov 2016
Arthrex Univers Revers CA Heads and Adapters
K151527 · Arthrex, Inc. · Apr 2016
EXACTECH EQUINOXE RESURFACING HUMERAL HEAD SYSTEM
K131298 · Exactech, Inc. · Nov 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