Cleared Special

K071032 - ARTHREX UNIVERS II SHOULDER PROSTHESIS

K071032 is the FDA 510(k) clearance for ARTHREX UNIVERS II SHOULDER PROSTHESIS by Arthrex, Inc.. It is a Class 2 Orthopedic device (product code KWS) cleared through the Special 510(k) pathway after a 131-day FDA review.

K071032 · Arthrex, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Aug 2007
Decision
131d
Days
Class 2
Risk

K071032 is an FDA 510(k) clearance for the ARTHREX UNIVERS II SHOULDER PROSTHESIS. Classified as Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented (product code KWS), Class II - Special Controls.

Submitted by Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on August 20, 2007 after a review of 131 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3660 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Arthrex, Inc. devices

Submission Details

510(k) Number K071032 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 2007
Decision Date August 20, 2007
Days to Decision 131 days
Submission Type Special
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
9d slower than avg
Panel avg: 122d · This submission: 131d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code KWS Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3660
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 - KWS Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented

All 152
Devices cleared under the same product code (KWS) and FDA review panel - the closest regulatory comparables to K071032.
AEQUALIS SHOULDER FRACTURE AND SHOULDER SYSTEMS
K081707 · Tornier, Inc. · Jul 2008
MODIFICATION TO DEPUY DELTA XTEND REVERSE SHOULDER SYSTEM
K081620 · DePuy Orthopaedics, Inc. · Jun 2008
ENCORE SHOULDER PRIMARY HUMERAL STEM, MODEL 500-00, ENCORE SHOULDER HUMERAL HEAD, MODEL 520-38
K080402 · Encore Medical, L.P. · Mar 2008
MODULAR HYBRID GLENOID
K060694 · Biomet Manufacturing Corp · Dec 2006
ANATOMICAL SHOULDER FRACTURE SYSTEM
K062029 · Zimmer GmbH · Oct 2006
SOLAR REUNION FRACTURE STEM
K062113 · Howmedica Osteonics Corp. · Oct 2006