Cleared Traditional

K030710 - BIO-MODULAR SHOULDER SYSTEM

K030710 is an FDA 510(k) clearance for BIO-MODULAR SHOULDER SYSTEM, manufactured by Biomet, Inc.. The device is a Class 2 Orthopedic device with product code KWT cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K030710 · Biomet, Inc. · Orthopedic device
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Jun 2003
Decision
90d
Days
Class 2
Risk

K030710 is an FDA 510(k) clearance for the BIO-MODULAR SHOULDER SYSTEM. Classified as Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented (product code KWT), Class II - Special Controls.

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on June 4, 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 888.3650 - 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 Biomet, Inc. devices

FDA 510(k) Submission Details - K030710

510(k) Number K030710 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 2003
Decision Date June 04, 2003
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWT Device Classification - Class 2, Special Controls

Product Code KWT Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3650
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 - KWT Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented

All 66
Devices cleared under the same product code (KWT) and FDA review panel - the closest regulatory comparables to K030710.
MOSAIC NON-MODULAR PROXIMAL BODY AND EAS OFFSET MODULAR HUMERAL HEAD
K042321 · Biomet Manufacturing Corp · Jan 2005
ZIMMER TRABECULAR METAL HUMERAL STEM
K041549 · Zimmer, Inc. · Sep 2004
INTERLOK BIO-MODULAR HUMERAL STEMS
K032507 · Biomet, Inc. · Sep 2003
COMPREHENSIVE HUMERAL FRACTURE SYSTEM
K023063 · Biomet Orthopedics, Inc. · Dec 2002
THE TRABECULAR METAL GLENOID-BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION, MODEL 4306
K022377 · Implex Corp. · Dec 2002
SHORT AND LONG SOFT TISSUE ATTACHMENT
K022079 · Biomet, Inc. · Sep 2002