Cleared Traditional

K031337 - ACUMEN SURGICAL NAVIGATION SYSTEM

K031337 is the FDA 510(k) clearance for ACUMEN SURGICAL NAVIGATION SYSTEM by Biomet, Inc.. It is a Class 2 Neurology device (product code HAW) cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K031337 · Biomet, Inc. · Neurology device
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Sep 2003
Decision
140d
Days
Class 2
Risk

K031337 is an FDA 510(k) clearance for the ACUMEN SURGICAL NAVIGATION SYSTEM. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on September 15, 2003 after a review of 140 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4560 - 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

Submission Details

510(k) Number K031337 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 2003
Decision Date September 15, 2003
Days to Decision 140 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
8d faster than avg
Panel avg: 148d · This submission: 140d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HAW Neurological Stereotaxic Instrument
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4560
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 - HAW Neurological Stereotaxic Instrument

All 217
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K031337.
ZIMMER ORTHO GUIDANCE SYSTEMS- KNEE INSTRUMENTS
K033011 · Zimmer, Inc. · Feb 2004
LEKSELL SURGIPLAN WITH IMAGEMERGE
K033340 · Elekta Instrument AB · Feb 2004
EBI ACUMEN SURGICAL NAVIGATION SYSTEM
K031732 · Ebi, L.P. · Oct 2003
CI TKR/UKR
K031770 · Brainlab AG · Aug 2003
MODIFICATION TO LEKSELL STEREOTACTIC SYSTEM
K031980 · Elekta Instrument AB · Jul 2003
ELEKTA LEKSELL STEREOTACTIC SYSTEM WITH MR POST KIT
K031999 · Elekta Instrument AB · Jul 2003