Cleared Traditional

K242373 - Mako Shoulder Application (1.0)

K242373 is the FDA 510(k) clearance for Mako Shoulder Application (1.0) by Mako Surgical Corp.. It is a Class 2 Orthopedic device (product code OLO) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K242373 · Mako Surgical Corp. · Orthopedic device
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Nov 2024
Decision
90d
Days
Class 2
Risk

K242373 is an FDA 510(k) clearance for the Mako Shoulder Application (1.0). 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 November 7, 2024 after a review of 90 days - within the typical 510(k) review window.

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 K242373 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 2024
Decision Date November 07, 2024
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
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 K242373.
Remex Spine Surgery Navigation Instrument
K243560 · Remex Medical Corp. · Dec 2024
AnyPlus Navigated Instruments System
K243073 · GS Medical Co., Ltd. · Dec 2024
TMINI Miniature Robotic System
K243285 · THINK Surgical, Inc. · Nov 2024
ROSA® Knee System
K242864 · Orthosoft Inc. (d/b/a) Zimmer CAS · Oct 2024
EGPS Navigated Instruments
K240160 · Astura Medical · Oct 2024
CROSSNAV Navigation Enabled Instruments and UNAS Navigation Arrays
K241893 · Medos International SARL · Sep 2024