Cleared Special

K083435 - ARTHREX UNIVERS II SHOULDER PEGGED GLENOID

K083435 is an FDA 510(k) clearance for ARTHREX UNIVERS II SHOULDER PEGGED GLENOID, 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 218-day FDA review.

K083435 · Arthrex, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2009
Decision
218d
Days
Class 2
Risk

K083435 is an FDA 510(k) clearance for the ARTHREX UNIVERS II SHOULDER PEGGED GLENOID. 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 June 26, 2009 after a review of 218 days - an extended review cycle.

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 - K083435

510(k) Number K083435 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 2008
Decision Date June 26, 2009
Days to Decision 218 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
96d slower than avg
Panel avg: 122d · This submission: 218d
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 K083435.
GRS GLENOID RESURFACING SYSTEM
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K091751 · DePuy Orthopaedics, Inc. · Jul 2009
AEQUALIS REVERSED FRACTURE SHOULDER PROTHESIS
K082120 · Tornier · Oct 2008
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
K083435 · ARTHREX UNIVERS II SHOULDER PEGGED GLENOID
Download PDF FDA Summary Arthrex, Inc.