Cleared Traditional

BIODRIVE MICRO SCREW SYSTEM (K092670) - FDA 510(k) Clearance

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

K092670 · Ebi,Llc D/B/A Biomet Trauma · Orthopedic device
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Nov 2009
Decision
80d
Days
Class 2
Risk

K092670 is an FDA 510(k) clearance for the BIODRIVE MICRO SCREW SYSTEM. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Ebi,Llc D/B/A Biomet Trauma (Parsippany, US). The FDA issued a Cleared decision on November 19, 2009 after a review of 80 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ebi,Llc D/B/A Biomet Trauma devices

Submission Details

510(k) Number K092670 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 2009
Decision Date November 19, 2009
Days to Decision 80 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
42d faster than avg
Panel avg: 122d · This submission: 80d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HRS Plate, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - HRS Plate, Fixation, Bone

All 696
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K092670.
BIOFOAM BONE WEDGE MODEL ASSORTED
K093950 · Wrightmedicaltechnologyinc · Jan 2010
SYNTHES (USA) 2.4MM LCP VOLAR COLUMN DISTAL RADIUS PLATES
K091644 · Synthes (Usa) · Dec 2009
AXSOS STRYKER LOCKED PLATING SYSTEM LINE EXTENSION OF CABLE PLUGS
K092178 · Howmedica Osteonics Corp. · Nov 2009
SYNTHES (USA) 2.4MM VA-LCP TWO-COLUMN NARROW VOLAR DISTAL RADIUS
K092556 · Synthes (Usa) · Nov 2009
SYNTHES 3.5 MM AND 4.55 MM CURVED NARROW AND BROAD LOCKING COMPRESSION PLATES (LCP)
K092609 · Synthes (Usa) · Nov 2009
SYNTHES LOCKING HAND PLATES
K092247 · Synthes (Usa) · Sep 2009