Cleared Traditional

TSolution One Total Knee Application (K191369) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence.

K191369 · THINK Surgical, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Oct 2019
Decision
139d
Days
Class 2
Risk

K191369 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 October 8, 2019 after a review of 139 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 THINK Surgical, Inc. devices

Submission Details

510(k) Number K191369 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 2019
Decision Date October 08, 2019
Days to Decision 139 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
17d slower than avg
Panel avg: 122d · This submission: 139d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Orthopedic devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT03017261 Completed Interventional Industry-sponsored

TSolution One® Total Knee Arthroplasty

TSolution One® Total Knee Arthroplasty Clinical Trial

115
Patients (actual)
6
Sites
Treatment
Purpose
Open label
Masking
Condition studied Osteoarthritis, Knee
Study design Single group
Eligibility All sexes · 21 Years+
Principal investigator Bernard N Stulberg, MD
Sponsor Think Surgical Inc. (industry)
Started 2017-02-18 → Primary completion 2019-06-26
Primary outcome
Percentage of Patients With Postoperative Coronal Limb Alignment More Than ±3 Deg From the Planned Coronal Limb Alignment
Secondary outcome
Percentage of Patients Experiencing a Composite of Relevant Safety Adverse Events
View full study on ClinicalTrials.gov

Regulatory Peers - OLO Orthopedic Stereotaxic Instrument

All 428
Devices cleared under the same product code (OLO) and FDA review panel - the closest regulatory comparables to K191369.
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