Cleared Special

K071032 - ARTHREX UNIVERS II SHOULDER PROSTHESIS

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

K071032 · Arthrex, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
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.

FDA 510(k) Submission Details - K071032

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.

KWS Device Classification - Class 2, Special Controls

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 191
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
TRABECULAR METAL GLENOID- B/F COMPLETE SHOULDER SOLUTION
K071090 · Zimmer Trabecular Metal Technology · Jun 2007
MODULAR HYBRID GLENOID
K060694 · Biomet Manufacturing Corp · Dec 2006
TOTAL AND HEMI SHOULDER SYSTEM
K060988 · Dvo Extremity Solutions, LLC · Dec 2006
K071032 · ARTHREX UNIVERS II SHOULDER PROSTHESIS
Download PDF FDA Summary Arthrex, Inc.