Cleared Traditional

K091998 - ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYST...

K091998 is the FDA 510(k) clearance for ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYST... by Mako Surgical Corp.. It is a Class 2 Orthopedic device (product code OLO) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K091998 · Mako Surgical Corp. · Orthopedic device
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Sep 2009
Decision
88d
Days
Class 2
Risk

K091998 is an FDA 510(k) clearance for the ROBOTIC ARM INTERACTIVE ORTHOPEDIC 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 September 28, 2009 after a review of 88 days - a notably fast clearance 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: 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 Mako Surgical Corp. devices

Submission Details

510(k) Number K091998 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2009
Decision Date September 28, 2009
Days to Decision 88 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
34d faster than avg
Panel avg: 122d · This submission: 88d
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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