Cleared Traditional

POINT Kinguide Agile Robotic Arm Surgical Stereotactic System (K252755) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K252755 · Point Robotics MedTech, Inc. · Orthopedic device
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Jan 2026
Decision
147d
Days
Class 2
Risk

K252755 is an FDA 510(k) clearance for the POINT Kinguide Agile Robotic Arm Surgical Stereotactic System. Classified as Orthopedic Stereotaxic Instrument within the OLO classification (a category covering orthopedic stereotaxic and surgical navigation instruments), Class II - Special Controls.

Submitted by Point Robotics MedTech, Inc. (New Taipei City, TW). The FDA issued a Cleared decision on January 23, 2026 after a review of 147 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 Point Robotics MedTech, Inc. devices

Submission Details

510(k) Number K252755 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 2025
Decision Date January 23, 2026
Days to Decision 147 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
25d slower than avg
Panel avg: 122d · This submission: 147d
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 344
Devices cleared under the same product code (OLO) and FDA review panel - the closest regulatory comparables to K252755.
Spine Guidance 5.3 Software
K252871 · Stryker Leibinger GmbH & Co KG · Feb 2026
Q Interbody Instruments
K252873 · K2m, Inc. · Feb 2026
Navigation Module of the Cortium® System
K252087 · Ulrich Medical USA, Inc. · Feb 2026
DYNAMIS™ Navigation System
K252962 · Promethean Restorative, LLC · Jan 2026
TMINI Miniature Robotic System
K253661 · THINK Surgical, Inc. · Dec 2025
Paradigm System
K252950 · Proprio, Inc. · Dec 2025