Cleared Special

K210668 - TSolution One Total Knee Application

K210668 is the FDA 510(k) clearance for TSolution One Total Knee Application by THINK Surgical, Inc.. It is a Class 2 Orthopedic device (product code OLO) cleared through the Special 510(k) pathway after a 27-day FDA review.

K210668 · THINK Surgical, Inc. · Orthopedic device
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Apr 2021
Decision
27d
Days
Class 2
Risk

K210668 is an FDA 510(k) clearance for the TSolution One 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 THINK Surgical, Inc. (Fremont, US). The FDA issued a Cleared decision on April 1, 2021 after a review of 27 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 K210668 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 2021
Decision Date April 01, 2021
Days to Decision 27 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
95d faster than avg
Panel avg: 122d · This submission: 27d
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 354
Devices cleared under the same product code (OLO) and FDA review panel - the closest regulatory comparables to K210668.
ROSA Partial Knee System
K210121 · Orthosoft D/B/A Zimmer Cas · Apr 2021
OMNIVision system
K203751 · Corin USA · Apr 2021
DeGen Navigated Instrumentation
K203816 · Degen Medical · Apr 2021
Navigated Spine Instruments
K203205 · Stryker Spine · Mar 2021
7D Surgical System - Drill Guide
K210555 · 7D Surgical, Inc. · Mar 2021
SPINEART Navigation Instrument System
K210472 · Spineart · Mar 2021