Cleared Traditional

K082874 - BIODRIVE CANNULATED SCREW SYSTEM

K082874 is an FDA 510(k) clearance for BIODRIVE CANNULATED SCREW SYSTEM, manufactured by Biomet Trauma. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K082874 · Biomet Trauma · Orthopedic device
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Feb 2009
Decision
129d
Days
Class 2
Risk

K082874 is an FDA 510(k) clearance for the BIODRIVE CANNULATED SCREW SYSTEM. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Biomet Trauma (Parsippany, US). The FDA issued a Cleared decision on February 5, 2009 after a review of 129 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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 Trauma devices

FDA 510(k) Submission Details - K082874

510(k) Number K082874 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2008
Decision Date February 05, 2009
Days to Decision 129 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
7d slower than avg
Panel avg: 122d · This submission: 129d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HWC Device Classification - Class 2, Special Controls

Product Code HWC Screw, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 - HWC Screw, Fixation, Bone

All 778
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K082874.
PARCUS TINTANIUM INTERFERENCE SCREW, MODELS: 10001-10012, 10014-10016, 10018-10020
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