Cleared Traditional

K020381 - EXPANDABLE KNEE

K020381 is an FDA 510(k) clearance for EXPANDABLE KNEE, manufactured by Biomet Orthopedics, Inc.. The device is a Class 2 Orthopedic device with product code KRO cleared through the Traditional 510(k) pathway after a 90-day FDA review.

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

FDA 510(k) Submission Details - K020381

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
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.

KRO Device Classification - Class 2, Special Controls

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 71
Devices cleared under the same product code (KRO) and FDA review panel - the closest regulatory comparables to K020381.
REPIPHYSIS LIMB SALVAGE SYSTEM
K021489 · Wrightmedicaltechnologyinc · Dec 2002
RT-PLUS PE INSERT CLAMP
K021714 · Plus Orthopedics · Jun 2002
REDUCED SIZE ONCOLOGY SALVAGE SYSTEM
K021260 · Biomet, Inc. · Jun 2002
NEXGEN COMPLETE KNEE SOLUTION ROTATNG HINGE KNEE
K013385 · Zimmer, Inc. · Jan 2002
RT-PLUS KNEE ADDITIONAL COMPONENTS
K013340 · Plus Orthopedics · Dec 2001
MOST OPTIONS SYSTEM
K013031 · Sulzer Orthopedics, Inc. · Dec 2001