Cleared Traditional

K130675 - ARTHREX UNIVERS II CA HEADS

K130675 is an FDA 510(k) clearance for ARTHREX UNIVERS II CA HEADS, manufactured by Arthrex, Inc.. The device is a Class 2 Orthopedic device with 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

FDA 510(k) Submission Details - K130675

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.

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 63
Devices cleared under the same product code (HSD) and FDA review panel - the closest regulatory comparables to K130675.
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SEVIIN SURFACE REPLACEMENT SHOULDER
K130635 · Ingen Orthopedics, LLC · Aug 2013
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K121714 · Smith & Nephew, Inc. · Sep 2012
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K112900 · Lima Corporate S.P.A. · Jun 2012