Cleared Traditional

K080678 - UNI-KNEE 2.0

K080678 is an FDA 510(k) clearance for UNI-KNEE 2.0, manufactured by Brainlab AG. The device is a Class 2 Neurology device with product code HAW cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K080678 · Brainlab AG · Neurology device
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Jun 2008
Decision
88d
Days
Class 2
Risk

K080678 is an FDA 510(k) clearance for the UNI-KNEE 2.0. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Brainlab AG (Feldkirchen, DE). The FDA issued a Cleared decision on June 6, 2008 after a review of 88 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

FDA 510(k) Submission Details - K080678

510(k) Number K080678 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 2008
Decision Date June 06, 2008
Days to Decision 88 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
60d faster than avg
Panel avg: 148d · This submission: 88d
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 333
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