Cleared Traditional

K031770 - CI TKR/UKR

K031770 is the FDA 510(k) clearance for CI TKR/UKR by Brainlab AG. It is a Class 2 Neurology device (product code HAW) cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K031770 · Brainlab AG · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2003
Decision
64d
Days
Class 2
Risk

K031770 is an FDA 510(k) clearance for the CI TKR/UKR. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Brainlab AG (Heimstetten, DE). The FDA issued a Cleared decision on August 12, 2003 after a review of 64 days - a notably fast clearance cycle.

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: 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 Brainlab AG devices

Submission Details

510(k) Number K031770 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 2003
Decision Date August 12, 2003
Days to Decision 64 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
84d faster than avg
Panel avg: 148d · This submission: 64d
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 K031770.
LEKSELL SURGIPLAN WITH IMAGEMERGE
K033340 · Elekta Instrument AB · Feb 2004
EBI ACUMEN SURGICAL NAVIGATION SYSTEM
K031732 · Ebi, L.P. · Oct 2003
ACUMEN SURGICAL NAVIGATION SYSTEM
K031337 · Biomet, Inc. · Sep 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
VECTORVISION FLUORO3D
K024192 · Brainlab AG · Jun 2003