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Tie-In Trapezium

by Wrightmedicaltechnologyinc 510(k)

Active United States

510(k) K033529

Overview

Prosthesis, Wrist, Carpal Trapezium is a device intended for use as a prosthetic replacement of the carpal trapezium bone in the wrist. It is classified under product code KYI and device class II with special controls.

The Tie-In Trapezium implant is supplied as a sterile, single-use device for orthopedic surgical procedures. It received FDA 510(k) clearance (K033529) on December 3, 2003, and is manufactured by Wright Medical Technology, Inc. No information on MRI safety, sizes, or storage conditions is provided in the data.

AI-generated from registry data, 1 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK033529 Date3 Dec 2003ClearedStatusActive

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
KYI
Device Class
Class II
Regulation
21 CFR Part 888.3770
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Other devices from Wrightmedicaltechnologyinc

See all devices from Wrightmedicaltechnologyinc →

Questions

  • What is the Tie-In Trapezium prosthesis used for?

    The Tie-In Trapezium prosthesis is intended for use as a prosthetic replacement of the carpal trapezium bone in the wrist during orthopedic surgical procedures. It is designed to restore function after trauma or degeneration affecting this specific carpal bone.

  • Is the Tie-In Trapezium implant sterile and single-use?

    Yes, the Tie-In Trapezium implant is supplied as a sterile, single-use device. This means it is intended for one surgical procedure only and should not be reprocessed or reused, ensuring patient safety and reducing infection risk.

  • What regulatory pathway was used for the Tie-In Trapezium device?

    The Tie-In Trapezium device received FDA 510(k) clearance, specifically under submission number K033529, which was granted on December 3, 2003. This indicates it was found substantially equivalent to a legally marketed predicate device.