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FDA 510(k)

RTS Lesser MTP Implant System

K-Number: K173491 · 2018-02-23

ApplicantIn2bones USA, LLC
Decision Date2018-02-23
Product CodeKWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

RTS Lesser MTP Implant System is a medical device manufactured by In2bones USA, LLC. It received FDA 510(k) clearance on 2018-02-23 under approval number K173491. The device is classified under product code KWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RTS Lesser MTP Implant System?

RTS Lesser MTP Implant System is a medical device that received FDA 510(k) clearance on 2018-02-23. It is manufactured by In2bones USA, LLC. The 510(k) number is K173491.

When was RTS Lesser MTP Implant System approved by the FDA?

RTS Lesser MTP Implant System received FDA 510(k) clearance on 2018-02-23, under approval number K173491.

What company makes RTS Lesser MTP Implant System?

RTS Lesser MTP Implant System is manufactured by In2bones USA, LLC.

What is the FDA product code for RTS Lesser MTP Implant System?

The FDA product code for RTS Lesser MTP Implant System is KWH.

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Related PubMed Literature

PMID: 39892748 Long-term Safety and Performance of a Suprachoroidal Pressure Sensor System: Results of the EYEMATE-SC Trial Follow-up Study. Ophthalmology (2025) PMID: 41966145 From Registry to Reality: Opportunities to Enhance Post-market Surveillance of High-Risk Medical Devices Comment on "Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review". International journal of health policy and management (2025) PMID: 39726899 How to improve the mechanical safety of a novel spinal implant while saving costs and time. JOR spine (2024)

Other Devices by In2bones USA, LLC

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Related Devices (Code: KWH)

K153609RTS Flexible 1 MPJ Implant w/GrommetsIn2bones USA, LLC K190136Fusion Silastic SystemFusion Orthopedics, LLC K191966NewPrim SystemBrm Extremities

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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