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FDA 510(k)

TSolution® One Total Knee Application

K-Number: K201255 · 2020-06-10

ApplicantTHINK Surgical, Inc.
Decision Date2020-06-10
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

TSolution® One Total Knee Application is a medical device manufactured by THINK Surgical, Inc.. It received FDA 510(k) clearance on 2020-06-10 under approval number K201255. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TSolution® One Total Knee Application?

TSolution® One Total Knee Application is a medical device that received FDA 510(k) clearance on 2020-06-10. It is manufactured by THINK Surgical, Inc.. The 510(k) number is K201255.

When was TSolution® One Total Knee Application approved by the FDA?

TSolution® One Total Knee Application received FDA 510(k) clearance on 2020-06-10, under approval number K201255.

What company makes TSolution® One Total Knee Application?

TSolution® One Total Knee Application is manufactured by THINK Surgical, Inc..

What is the FDA product code for TSolution® One Total Knee Application?

The FDA product code for TSolution® One Total Knee Application is OLO.

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Related PubMed Literature

PMID: 40948288 [Research on Application of Medical Device Real-World Evidence in Regulatory Decisions of the United States]. Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation (2025)

Other Devices by THINK Surgical, Inc.

K162195TSolution One Cup1 Surgical System K153647TSolution One w/ACG+ Surgical System K170430TSolution One Surgical System Model 210 K193135TSolution One Total Knee Application K191369TSolution One Total Knee Application K180127TCAT (R) THA Instrument Tray Set

View all 21 devices →

Related Devices (Code: OLO)

K162375Envision 3D: Image Guidance System7D Surgical, Inc. K162341Stryker OrthoMap Precision Knee systemStryker Leibinger GmbH & Co KG K162195TSolution One Cup1 Surgical SystemTHINK Surgical, Inc. K160385Precision ScrewCryptych Pty, Ltd. K153700Aesculap(R) Implant Systems (AIS) S4 Navigation InstrumentsAesculap Implant Systems, LLC K153240Styrker OrthoMap Express Knee SystemStryker Corporate

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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