Cleared Traditional

K081867 - MAKO SURGICAL TACTILE GUIDANCE SYSTEM VERSION 2.0

K081867 is an FDA 510(k) clearance for MAKO SURGICAL TACTILE GUIDANCE SYSTEM V..., manufactured by Mako Surgical Corp.. The device is a Class 2 Neurology device with product code HAW cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K081867 · Mako Surgical Corp. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2008
Decision
147d
Days
Class 2
Risk

K081867 is an FDA 510(k) clearance for the MAKO SURGICAL TACTILE GUIDANCE SYSTEM VERSION 2.0. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Mako Surgical Corp. (Fort Lauderdale, US). The FDA issued a Cleared decision on November 25, 2008 after a review of 147 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 Mako Surgical Corp. devices

FDA 510(k) Submission Details - K081867

510(k) Number K081867 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2008
Decision Date November 25, 2008
Days to Decision 147 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
1d faster than avg
Panel avg: 148d · This submission: 147d
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 331
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K081867.
CRANIAL IMAGE GUIDED SURGERY SYSTEM
K082060 · Brainlab AG · May 2009
LEKSELL STEREOTACTIC SYSTEM WITH REUSABLE FIXATION SCREWS
K080355 · Elekta Instrument AB · May 2009
PIGALILEO TOTAL HIP REPLACEMENT (THR) SOFTWARE APPLICATION V3.0
K083565 · Smith & Nephew, Inc. · Feb 2009
PIGALILEO CAS, VERSION 4.0 AND TKR BASE, VERSION 2.1
K082267 · Smith & Nephew, Inc. · Oct 2008
BRAINLAB KNEE ESSENTIAL, BRAINLAB KNEE UNLIMITED CI KNEE, CI KNEE UNLIMITED
K073615 · Brainlab AG · Sep 2008
PIGALILEO 4TH GENERATION SYSTEM
K080875 · Smith & Nephew, Inc. · Jul 2008