Cleared Traditional

K031280 - ULTRA-DRIVE 3

K031280 is an FDA 510(k) clearance for ULTRA-DRIVE 3, manufactured by Biomet, Inc.. The device is a Class 2 Neurology device with product code JDX cleared through the Traditional 510(k) pathway after a 153-day FDA review.

K031280 · Biomet, Inc. · Neurology device
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Sep 2003
Decision
153d
Days
Class 2
Risk

K031280 is an FDA 510(k) clearance for the ULTRA-DRIVE 3. Classified as Instrument, Surgical, Sonic And Accessory/attachment (product code JDX), Class II - Special Controls.

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on September 22, 2003 after a review of 153 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 888.4580 - the FDA neurology device 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 Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Biomet, Inc. devices

FDA 510(k) Submission Details - K031280

510(k) Number K031280 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 2003
Decision Date September 22, 2003
Days to Decision 153 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 148d · This submission: 153d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDX Device Classification - Class 2, Special Controls

Product Code JDX Instrument, Surgical, Sonic And Accessory/attachment
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.4580
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 Neurology devices follow this clearance model.

Regulatory Peers - JDX Instrument, Surgical, Sonic And Accessory/attachment

All 12
Devices cleared under the same product code (JDX) and FDA review panel - the closest regulatory comparables to K031280.
PIEZOSURGERY FLEX
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PIEZOELECTRIC SYSTEM
K100410 · Satelec · Apr 2010
OSCAR, MODEL OE3000DB
K051053 · Orthosonics, Ltd. · Jul 2005
VENTED CEMENT RESTRICTOR
K022729 · Amedica Corp. · Nov 2002
OSCAR ORTHOSONICS SYSTEM FOR CEMENTED ARTHROPLASTY REVISION
K961725 · C.L. Mcintosh & Assoc., Inc. · Aug 1996
ITM SONIC SURGERY SYSTEM
K912931 · Buckman Co., Inc. · Oct 1991