Cleared Traditional

K151527 - Arthrex Univers Revers CA Heads and Adapters

K151527 is an FDA 510(k) clearance for Arthrex Univers Revers CA Heads and Ada..., 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 316-day FDA review.

K151527 · Arthrex, Inc. · Orthopedic device
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Apr 2016
Decision
316d
Days
Class 2
Risk

K151527 is an FDA 510(k) clearance for the Arthrex Univers Revers CA Heads and Adapters. 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 April 19, 2016 after a review of 316 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K151527

510(k) Number K151527 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 2015
Decision Date April 19, 2016
Days to Decision 316 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
194d slower than avg
Panel avg: 122d · This submission: 316d
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 K151527.
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Arthrex Univers Revers Shoulder Prosthesis System
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HemiCAP Humeral Head XL (HHXL) Articular Resurfacing System
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EXACTECH EQUINOXE RESURFACING HUMERAL HEAD SYSTEM
K131298 · Exactech, Inc. · Nov 2013
HUMELOCK II CEMENTLESS SHOULDER SYSTEM
K130759 · Fx Solutions · Nov 2013