Cleared Special

K162195 - TSolution One Cup1 Surgical System

K162195 is an FDA 510(k) clearance for TSolution One Cup1 Surgical System, manufactured by THINK Surgical, Inc.. The device is a Class 2 Orthopedic device with product code OLO cleared through the Special 510(k) pathway after a 40-day FDA review.

K162195 · THINK Surgical, Inc. · Orthopedic device
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Sep 2016
Decision
40d
Days
Class 2
Risk

K162195 is an FDA 510(k) clearance for the TSolution One Cup1 Surgical 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 September 14, 2016 after a review of 40 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

FDA 510(k) Submission Details - K162195

510(k) Number K162195 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 2016
Decision Date September 14, 2016
Days to Decision 40 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
82d faster than avg
Panel avg: 122d · This submission: 40d
Pathway characteristics
Modification to existing cleared device.

OLO Device Classification - Class 2, Special Controls

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 Consultant

The Cro Group, Inc.
GLEN EMELOCK

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - OLO Orthopedic Stereotaxic Instrument

All 433
Devices cleared under the same product code (OLO) and FDA review panel - the closest regulatory comparables to K162195.
OrthAlign Plus System
K162962 · Orthalign, Inc. · Jan 2017
Envision 3D: Image Guidance System
K162375 · 7D Surgical, Inc. · Dec 2016
Stryker OrthoMap Precision Knee system
K162341 · Stryker Leibinger GmbH & Co KG · Oct 2016
Precision Screw
K160385 · Cryptych Pty, Ltd. · Jul 2016
Aesculap(R) Implant Systems (AIS) S4 Navigation Instruments
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Styrker OrthoMap Express Knee System
K153240 · Stryker Corporate · Jul 2016