Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

TSolution One Total Knee Application

K-Number: K193135 · 2019-12-11

ApplicantTHINK Surgical, Inc.
Decision Date2019-12-11
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 2019-12-11 under approval number K193135. 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 2019-12-11. It is manufactured by THINK Surgical, Inc.. The 510(k) number is K193135.

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

TSolution One Total Knee Application received FDA 510(k) clearance on 2019-12-11, under approval number K193135.

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.

Related Clinical Trials

NCT06727942 Virtual Reality-Infused Treadmill Training on Aging-Related Outcomes RECRUITING NCT06420323 NovoX®Cup as Primary Dressing After Breast Reduction ACTIVE_NOT_RECRUITING NCT07370051 Effect of Topical Oxygen and LED Light Therapy on Nipple Crack NOT_YET_RECRUITING NCT07409571 Palatal Wound Healing After Free Gingival Graft Surgery RECRUITING NCT07602933 Photobiomodulation Effects on Fatigue and Muscle Damage Induced by NMES NOT_YET_RECRUITING NCT07582809 Clinical Investigation to Observe the Long-term Safety and Efficacy of the Digital Medical Device 'BELL-001' in Patients Diagnosed With Insomnia NOT_YET_RECRUITING

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 K191369TSolution One Total Knee Application K180127TCAT (R) THA Instrument Tray Set K203040TSolution One Total Knee Application

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.

↑