Cleared Traditional

K241011 - Mako Total Knee Application

K241011 is the FDA 510(k) clearance for Mako Total Knee Application by Mako Surgical Corp.. It is a Class 2 Orthopedic device (product code OLO) cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K241011 · Mako Surgical Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2024
Decision
60d
Days
Class 2
Risk

K241011 is an FDA 510(k) clearance for the Mako Total Knee Application. 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. (Weston, US). The FDA issued a Cleared decision on June 11, 2024 after a review of 60 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 K241011 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 2024
Decision Date June 11, 2024
Days to Decision 60 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 122d · This submission: 60d
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 354
Devices cleared under the same product code (OLO) and FDA review panel - the closest regulatory comparables to K241011.
TELIGEN System Navigation Ready Instruments
K233254 · DePuy Synthes · Jun 2024
ExcelsiusFlex™
K240721 · Globus Medical, Inc. · Jun 2024
INNOVERSE Navigation Instruments
K241082 · Innosys Co., Ltd. · Jun 2024
Spine Guidance Software (version 5.0)
K240662 · Stryker Leibinger GmbH & Co KG · Jun 2024
Invictus Robotic Navigation Instruments
K240951 · Alphatec Spine · Jun 2024
VELYS Robotic-Assisted Solution
K240211 · Depuy Ireland UC · Jun 2024