Cleared Traditional

K022079 - SHORT AND LONG SOFT TISSUE ATTACHMENT

K022079 is the FDA 510(k) clearance for SHORT AND LONG SOFT TISSUE ATTACHMENT by Biomet, Inc.. It is a Class 2 Orthopedic device (product code KWT) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K022079 · Biomet, Inc. · Orthopedic device
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Sep 2002
Decision
90d
Days
Class 2
Risk

K022079 is an FDA 510(k) clearance for the SHORT AND LONG SOFT TISSUE ATTACHMENT. 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 24, 2002 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

Submission Details

510(k) Number K022079 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 2002
Decision Date September 24, 2002
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.

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 K022079.
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
3-PIECE PROXIMAL HUMERAL REPLACEMENT SYSTEM
K020045 · Biomet Orthopedics, Inc. · Jan 2002
EPOCA CODR STEM AND HEAD
K014049 · Stelkast Company · Jan 2002
BIOMET BI-POLAR SHOULDER SYSTEM
K002998 · Biomet, Inc. · Oct 2000