Cleared Special

K032507 - INTERLOK BIO-MODULAR HUMERAL STEMS

K032507 is the FDA 510(k) clearance for INTERLOK BIO-MODULAR HUMERAL STEMS by Biomet, Inc.. It is a Class 2 Orthopedic device (product code KWT) cleared through the Special 510(k) pathway after a 22-day FDA review.

K032507 · Biomet, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2003
Decision
22d
Days
Class 2
Risk

K032507 is an FDA 510(k) clearance for the INTERLOK BIO-MODULAR HUMERAL STEMS. 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 September 5, 2003 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3650 - 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Biomet, Inc. devices

Submission Details

510(k) Number K032507 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2003
Decision Date September 05, 2003
Days to Decision 22 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
100d faster than avg
Panel avg: 122d · This submission: 22d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 59
Devices cleared under the same product code (KWT) and FDA review panel - the closest regulatory comparables to K032507.
DISCOVERY-MOSAIC TOTAL HUMERUS SYSTEM
K043505 · Biomet, Inc. · Feb 2005
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
BIO-MODULAR SHOULDER SYSTEM
K030710 · Biomet, Inc. · Jun 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