Cleared Special

K020045 - 3-PIECE PROXIMAL HUMERAL REPLACEMENT SY...

K020045 is the FDA 510(k) clearance for 3-PIECE PROXIMAL HUMERAL REPLACEMENT SY... by Biomet Orthopedics, Inc.. It is a Class 2 Orthopedic device (product code KWT) cleared through the Special 510(k) pathway after a 23-day FDA review.

K020045 · Biomet Orthopedics, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2002
Decision
23d
Days
Class 2
Risk

K020045 is an FDA 510(k) clearance for the 3-PIECE PROXIMAL HUMERAL REPLACEMENT SYSTEM. Classified as Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented (product code KWT), Class II - Special Controls.

Submitted by Biomet Orthopedics, Inc. (Warsaw, US). The FDA issued a Cleared decision on January 30, 2002 after a review of 23 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 Orthopedics, Inc. devices

Submission Details

510(k) Number K020045 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 07, 2002
Decision Date January 30, 2002
Days to Decision 23 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
99d faster than avg
Panel avg: 122d · This submission: 23d
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 K020045.
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
EPOCA CODR STEM AND HEAD
K014049 · Stelkast Company · Jan 2002
BIOMET BI-POLAR SHOULDER SYSTEM
K002998 · Biomet, Inc. · Oct 2000
BIPOLAR SHOULDER PROSTHESIS
K991585 · Biomet, Inc. · Aug 1999