Cleared Traditional

K031337 - ACUMEN SURGICAL NAVIGATION SYSTEM

K031337 is an FDA 510(k) clearance for ACUMEN SURGICAL NAVIGATION SYSTEM, manufactured by Biomet, Inc.. The device is a Class 2 Neurology device with 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

FDA 510(k) Submission Details - K031337

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.

HAW Device Classification - Class 2, Special Controls

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 334
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