Cleared Traditional

BROOKER TIBIA NAILS (K002057) - FDA 510(k) Clearance

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

K002057 · Biomet Orthopedics, Inc. · Orthopedic device
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Oct 2000
Decision
90d
Days
Class 2
Risk

K002057 is an FDA 510(k) clearance for the BROOKER TIBIA NAILS. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Biomet Orthopedics, Inc. (Warsaw, US). The FDA issued a Cleared decision on October 4, 2000 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 Biomet Orthopedics, Inc. devices

Submission Details

510(k) Number K002057 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 2000
Decision Date October 04, 2000
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 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 257
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K002057.
T2 FEMORAL NAIL
K010801 · Howmedica Osteonics Corp. · Apr 2001
TITAN TIBIAL NAIL
K003018 · Howmedica Osteonics Corp. · Dec 2000
ACE AIM TTC FUSION NAIL
K003797 · DePuy Orthopaedics, Inc. · Dec 2000
TITANIUM PEDIATRIC FEMORAL NAIL
K993956 · Biomet, Inc. · Dec 1999
WICHITA FUSION NAIL FULLY THREADED SELF-TAPPING SCREW
K993603 · Howmedica Osteonics Corp. · Nov 1999
MODIFIED LONG LENGTH GAMMA NAIL
K993670 · Howmedica Osteonics Corp. · Nov 1999