Cleared Traditional

K020384 - T2 ARTHRODESIS NAIL SYSTEM

K020384 is the FDA 510(k) clearance for T2 ARTHRODESIS NAIL SYSTEM by Howmedica Osteonics Corp.. It is a Class 2 Orthopedic device (product code HSB) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K020384 · Howmedica Osteonics Corp. · Orthopedic device
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May 2002
Decision
90d
Days
Class 2
Risk

K020384 is an FDA 510(k) clearance for the T2 ARTHRODESIS NAIL SYSTEM. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Howmedica Osteonics Corp. (Allendale, 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 888.3020 - 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 Howmedica Osteonics Corp. devices

Submission Details

510(k) Number K020384 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.

Device Classification

Product Code HSB Rod, Fixation, Intramedullary And Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3020
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 - HSB Rod, Fixation, Intramedullary And Accessories

All 326
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K020384.
TITANIUM ANKLE ARTHRODESIS NAIL
K021786 · Biomet, Inc. · Aug 2002
S2 TIBIAL NAIL
K022481 · Howmedica Osteonics Corp. · Aug 2002
T2 FEMORAL NAIL
K021744 · Howmedica Osteonics Corp. · Jun 2002
S2 FEMORAL NAIL
K021026 · Howmedica Osteonics Corp. · Apr 2002
S2 TIBIAL NAIL
K021027 · Howmedica Osteonics Corp. · Apr 2002
LONG LENGTH GAMMA NAIL
K020773 · Howmedica Osteonics Corp. · Apr 2002