Cleared Traditional

K020345 - ARTHREX UNIVERS FRACTURE PROSTHESIS

K020345 is the FDA 510(k) clearance for ARTHREX UNIVERS FRACTURE PROSTHESIS by Arthrex, Inc.. It is a Class 2 Orthopedic device (product code KWS) cleared through the Traditional 510(k) pathway after a 217-day FDA review.

K020345 · Arthrex, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Sep 2002
Decision
217d
Days
Class 2
Risk

K020345 is an FDA 510(k) clearance for the ARTHREX UNIVERS FRACTURE 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 September 6, 2002 after a review of 217 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. 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

Submission Details

510(k) Number K020345 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 2002
Decision Date September 06, 2002
Days to Decision 217 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
95d slower than avg
Panel avg: 122d · This submission: 217d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K020345.
AEQUALIS SHOULDER FRACTURE SYSTEM
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K031449 · Implex Corp. · Sep 2003
MODULAR NEER 3 HUMERAL STEMS AND MODULAR NEER 3 HUMERAL HEADS
K030344 · Smith & Nephew, Inc. · Mar 2003
VAPORIZED HYDROGEN PEROXIDE (VHP) STERILIZATION OF UNMWPE COMPONENTS IN THE COFIELD TOTAL SHOULDER SYSTEM, THE NEER II
K012788 · Smith & Nephew, Inc. · Mar 2002
3D HUMERAL HEADS
K012378 · Smith & Nephew, Inc. · Dec 2001
PLASMA SPRAYED SHOULDER
K003324 · Encore Orthopedics, Inc. · Dec 2001