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RTS Flexible 1 MPJ Implant w/Grommets

FDA 510(k)

Class II (US FDA 510(k))

510(k) K153609

by In2Bones USA, LLC

Identifiers

510(k) Number
K153609 FDA 510(k)
FDA Product Code
KWH FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3720 FDA 510(k)
Regulation Number
888.3720 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The RTS Flexible 1 MPJ Implant w/Grommets is a double-stemmed, constrained silicone prosthesis designed to replace the first metatarsophalangeal (MPJ) joint. It is intended for use in the treatment of hallux limitus or hallux rigidus, painful rheumatoid arthritis, hallux abducto valgus associated with arthritis, and unstable or painful joints from previous surgery.

This device is supplied as a single-use implant and is regulated under FDA 510(k) clearance with product code KWH. It is classified as a Class II device and is manufactured by In2Bones USA, LLC. The implant is available in various sizes as specified by the manufacturer and is intended for orthopedic use.

Frequently asked questions

What is the RTS Flexible 1 MPJ Implant w/Grommets used for?

This double-stemmed, constrained silicone prosthesis is designed to replace the first metatarsophalangeal joint. It's intended for treating hallux limitus or hallux rigidus, painful rheumatoid arthritis, hallux abducto valgus associated with arthritis, and unstable or painful joints from previous surgery.

How is the RTS Flexible 1 MPJ Implant supplied and is it reusable?

The implant is supplied as a single-use device and is not intended for reuse. It comes in various sizes as specified by the manufacturer, In2Bones USA, LLC, and is regulated under FDA 510(k) clearance with product code KWH.

What is the regulatory classification of this implant?

The RTS Flexible 1 MPJ Implant w/Grommets is classified as a Class II device and is regulated under FDA 510(k) clearance with product code KWH. It received FDA clearance on September 8, 2016, with decision code SESE.

What materials are used in the RTS Flexible 1 MPJ Implant?

The implant is a double-stemmed, constrained silicone prosthesis designed to replace the first metatarsophalangeal joint. The specific silicone formulation and other material details are not provided in the available device data.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: RTS Flexible 1 MPJ Implant w/Grommets (K153609) - Innolitics, PDF DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and ..., RTS® Flexible 1ST MPJ Implant | AI Chat & PDF | Manualzz, RTS Flexible 1 MPJ Implant W/Grommets 510(k) K153609 - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
In2Bones USA, LLC

Sources (1)

  • FDA 510(k) K153609 24 fields · synced Sep 27, 2026