Cleared Traditional

K083644 - MAKO SURGICAL TACTILE GUIDANCE SYSTEM-HIP

K083644 is the FDA 510(k) clearance for MAKO SURGICAL TACTILE GUIDANCE SYSTEM-HIP by Mako Surgical Corp.. It is a Class 2 Orthopedic device (product code OLO) cleared through the Traditional 510(k) pathway after a 192-day FDA review.

K083644 · Mako Surgical Corp. · Orthopedic device
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Jun 2009
Decision
192d
Days
Class 2
Risk

K083644 is an FDA 510(k) clearance for the MAKO SURGICAL TACTILE GUIDANCE SYSTEM-HIP. Classified as Orthopedic Stereotaxic Instrument within the OLO classification (a category covering orthopedic stereotaxic and surgical navigation instruments), Class II - Special Controls.

Submitted by Mako Surgical Corp. (Ft. Lauderdale, US). The FDA issued a Cleared decision on June 19, 2009 after a review of 192 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 882.4560 - the FDA orthopedic device regulatory 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 Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Mako Surgical Corp. devices

Submission Details

510(k) Number K083644 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 2008
Decision Date June 19, 2009
Days to Decision 192 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d slower than avg
Panel avg: 122d · This submission: 192d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OLO Orthopedic Stereotaxic Instrument
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4560
Definition Stereotaxic Guidance During Orthopedic Surgery Procedures. Indicated For Orthopedic Joint Or Spine Surgery. Neurological Stereotaxic Instruments Are Classified Under Product Code Haw.
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 Orthopedic devices follow this clearance model.

Regulatory Peers - OLO Orthopedic Stereotaxic Instrument

All 355
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