Skip to content

Finger Joint Prosthesis

by Avanta Orthopaedics, Inc. 510(k)

Active United States

510(k) K013629

Overview

The Finger Joint Prosthesis is a medical device classified as a Prosthesis, Finger, Constrained, Polymer. It is designed to replace a damaged finger joint and restore function to the affected finger.

This device is supplied as a single-use implant and is intended for use in orthopedic procedures. It has received FDA 510(k) clearance with the product code KYJ and is classified as Class II under Special Controls. The device is available in various sizes as indicated by the multiple registration numbers associated with this clearance.

AI-generated from registry data, 24 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK013629 Date25 Jan 2002ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
KYJ
Device Class
Class II
Regulation
21 CFR Part 888.3230
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Other devices from Avanta Orthopaedics, Inc.

See all devices from Avanta Orthopaedics, Inc. →

Questions

  • What is the Finger Joint Prosthesis used for?

    The Finger Joint Prosthesis is designed to replace a damaged finger joint and restore function to the affected finger. It is intended for use in orthopedic procedures as a single-use implant.

  • How is the Finger Joint Prosthesis supplied?

    The device is supplied as a single-use implant and is available in various sizes as indicated by the multiple registration numbers associated with this FDA 510(k) clearance.

  • What is the regulatory status of the Finger Joint Prosthesis?

    The Finger Joint Prosthesis has received FDA 510(k) clearance with the product code KYJ and is classified as Class II under Special Controls. It is manufactured by Avanta Orthopaedics, Inc.

  • Is the Finger Joint Prosthesis reusable?

    No, the Finger Joint Prosthesis is supplied as a single-use implant and should not be reused. Each device is designed for one-time use only to ensure patient safety and device integrity.