Cleared Traditional

AMATOMICAL SHOULDER WITH REMOVABLE HEAD (K030259) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K030259 · Centerplus Orthopedics, Inc. · Orthopedic device
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Apr 2003
Decision
90d
Days
Class 2
Risk

K030259 is an FDA 510(k) clearance for the AMATOMICAL SHOULDER WITH REMOVABLE HEAD. Classified as Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented (product code KWS), Class II - Special Controls.

Submitted by Centerplus Orthopedics, Inc. (Austin, US). The FDA issued a Cleared decision on April 24, 2003 after a review of 90 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. 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 Centerplus Orthopedics, Inc. devices

Submission Details

510(k) Number K030259 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 2003
Decision Date April 24, 2003
Days to Decision 90 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 122d · This submission: 90d
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 92
Devices cleared under the same product code (KWS) and FDA review panel - the closest regulatory comparables to K030259.
DEPUY GLOBAL SHOULDER CROSSLINK GLENOID
K052472 · DePuy Orthopaedics, Inc. · Oct 2005
EXACTECH EQUINOXE SHOULDER SYSTEM
K042021 · Exactech, Inc. · Oct 2004
COMPREHENSIVE HUMERAL FRACTURE POSITIONING SLEEVE
K033506 · Biomet, Inc. · Feb 2004
MODULAR NEER 3 HUMERAL STEMS AND MODULAR NEER 3 HUMERAL HEADS
K030344 · Smith & Nephew, Inc. · Mar 2003
ARTHREX UNIVERS FRACTURE PROSTHESIS
K020345 · Arthrex, Inc. · Sep 2002
VAPORIZED HYDROGEN PEROXIDE (VHP) STERILIZATION OF UNMWPE COMPONENTS IN THE COFIELD TOTAL SHOULDER SYSTEM, THE NEER II
K012788 · Smith & Nephew, Inc. · Mar 2002