Cleared Special

K232802 - TMINI Miniature Robotic System

K232802 is the FDA 510(k) clearance for TMINI Miniature Robotic System by THINK Surgical, Inc.. It is a Class 2 Orthopedic device (product code OLO) cleared through the Special 510(k) pathway after a 30-day FDA review.

K232802 · THINK Surgical, Inc. · Orthopedic device
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Oct 2023
Decision
30d
Days
Class 2
Risk

K232802 is an FDA 510(k) clearance for the TMINI™ Miniature Robotic 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 THINK Surgical, Inc. (Fremont, US). The FDA issued a Cleared decision on October 12, 2023 after a review of 30 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all THINK Surgical, Inc. devices

Submission Details

510(k) Number K232802 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 2023
Decision Date October 12, 2023
Days to Decision 30 days
Submission Type Special
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
92d faster than avg
Panel avg: 122d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 364
Devices cleared under the same product code (OLO) and FDA review panel - the closest regulatory comparables to K232802.
Vital™ Navigation System
K233443 · Zimvie Spine (Zimmer Biomet Spine, Inc.) · Nov 2023
ATEC Posterior Navigated Disc Prep Instruments
K232345 · Alphatec Spine, Inc. · Nov 2023
CoreLink Robotic Navigation Instruments
K231494 · Corelink, LLC · Oct 2023
Invictus Robotic Navigation Instruments
K232044 · Alphatec Spine, Inc. · Oct 2023
TriALTIS Navigation Enabled Instruments
K231527 · Medos International S?rl · Sep 2023
Fusion Robotic Navigation System
K232413 · Alphatec Spine, Inc. · Sep 2023