Cleared Traditional

EXPANDABLE KNEE (K020381) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K020381 · Biomet Orthopedics, Inc. · Orthopedic device
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May 2002
Decision
90d
Days
Class 2
Risk

K020381 is an FDA 510(k) clearance for the EXPANDABLE KNEE. Classified as Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer (product code KRO), Class II - Special Controls.

Submitted by Biomet Orthopedics, Inc. (Warsaw, US). The FDA issued a Cleared decision on May 6, 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 888.3510 - 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 Orthopedics, Inc. devices

Submission Details

510(k) Number K020381 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 2002
Decision Date May 06, 2002
Days to Decision 90 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
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 KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3510
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 - KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer

All 53
Devices cleared under the same product code (KRO) and FDA review panel - the closest regulatory comparables to K020381.
GLOBAL MODULAR REPLACEMENT SYSTEM (GMRS)
K023087 · Howmedica Osteonics Corp. · Dec 2002
REPIPHYSIS LIMB SALVAGE SYSTEM
K021489 · Wrightmedicaltechnologyinc · Dec 2002
REDUCED SIZE ONCOLOGY SALVAGE SYSTEM
K021260 · Biomet, Inc. · Jun 2002
NEXGEN COMPLETE KNEE SOLUTION ROTATNG HINGE KNEE
K013385 · Zimmer, Inc. · Jan 2002
GUARDIAN LIMB SALVAGE SYSTEM
K013035 · Wrightmedicaltechnologyinc · Dec 2001
ORTHOGENESIS LPS PROXIMAL TIBIAL REPLACEMENT AND ORTHOGENESIS LPS TIBIAL BEARING
K011810 · Depuy, Inc. · Sep 2001