Cleared Special

BIOMET BI-POLAR SHOULDER SYSTEM (K002998) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K002998 · Biomet, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2000
Decision
10d
Days
Class 2
Risk

K002998 is an FDA 510(k) clearance for the BIOMET BI-POLAR 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 October 6, 2000 after a review of 10 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 K002998 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2000
Decision Date October 06, 2000
Days to Decision 10 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
112d faster than avg
Panel avg: 122d · This submission: 10d
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 42
Devices cleared under the same product code (KWT) and FDA review panel - the closest regulatory comparables to K002998.
INTERLOK BIO-MODULAR HUMERAL STEMS
K032507 · Biomet, Inc. · Sep 2003
BIO-MODULAR SHOULDER SYSTEM
K030710 · Biomet, Inc. · Jun 2003
SHORT AND LONG SOFT TISSUE ATTACHMENT
K022079 · Biomet, Inc. · Sep 2002
BIPOLAR SHOULDER PROSTHESIS
K991585 · Biomet, Inc. · Aug 1999
GLOBAL FX HUMERAL STEM, GLOBAL ADVANTAGE HUMERAL HEAD
K984541 · DePuy Orthopaedics, Inc. · Jan 1999
NEW ZIMMER SHOULDER SYSTEM
K982981 · Zimmer, Inc. · Dec 1998