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Duafit Interphalangeal Implant, PEEK-Fuse Interphalangeal Implant

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K132912

by In2Bones SAS

Identifiers

510(k) Number
K132912 FDA 510(k)
FDA Product Code
HWC FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3040 FDA 510(k)
Regulation Number
888.3040 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Duafit Interphalangeal Implant is a PEEK-based orthopedic device designed for interphalangeal joint stabilization. It is classified as an interphalangeal implant, specifically engineered to restore joint congruity and maintain alignment in finger joints, aiding functional recovery after trauma or degenerative conditions.

This implant is supplied sterile and intended for single-use in surgical procedures. Constructed from PEEK (polyether ether ketone), it is compatible with MRI environments and available in standardized sizes to accommodate various anatomical requirements. Authorized under FDA 510(k) clearance, MDD, and MDR, it adheres to regulatory standards for orthopedic implants and is intended for use in controlled clinical settings by qualified surgeons.

Frequently asked questions

What types of finger joint issues is the Duafit Interphalangeal Implant designed to address, and how does it help?

The Duafit Interphalangeal Implant is specifically engineered to stabilize interphalangeal joints in fingers affected by trauma or degenerative conditions. It restores joint congruity and maintains proper alignment, which aids in functional recovery by providing structural support where natural joint stability has been compromised.

Is the Duafit Implant reusable, or is it intended for single-use only? How does this affect its sterility?

The Duafit Interphalangeal Implant is explicitly intended for single-use in surgical procedures. It is supplied sterile to ensure safety and reliability for one-time use, eliminating the need for reprocessing or sterilization between patients.

What materials is the implant made from, and does this affect its compatibility with common medical imaging techniques?

The implant is constructed from PEEK (polyether ether ketone), a biocompatible material known for its strength and durability. One key advantage of PEEK is its compatibility with MRI environments, making it suitable for patients who may require follow-up imaging after surgery.

Are there different sizes available for the Duafit Implant, and how does this accommodate varying anatomical needs?

Yes, the Duafit Interphalangeal Implant comes in standardized sizes to accommodate the anatomical variations found in finger joints. This ensures surgeons can select the appropriate size for optimal fit and functional restoration during procedures.

What regulatory pathways has the Duafit Implant followed, and how does this ensure its safety and effectiveness?

The Duafit Implant has undergone regulatory review through FDA 510(k) clearance, as well as compliance with the Medical Device Directive (MDD) and the Medical Device Regulation (MDR). These pathways confirm its substantial equivalence to existing devices, adherence to safety standards, and suitability for use in controlled clinical settings by qualified surgeons.

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.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
In2Bones SAS

Sources (2)

  • FDA 510(k) K132912 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026