Hedrocel Trabecular Metal Reconstruction System, Model 06-165-ZZZZ

No FDA recalls found in the data synced 22 Oct 2026.

Full name

The Hedrocel Trabecular Metal Reconstruction System, Model 06-165-Zzzz

510(k) Number

K033384 ↗

FDA Product Code

JDK

Device Class

Class II

Regulation

21 CFR Part 878.3300

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

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• What is the Hedrocel Trabecular Metal Reconstruction System used for?

  The Hedrocel Trabecular Metal Reconstruction System is designed to reinforce weak and/or deficient bony tissues in orthopaedic surgical procedures. It is indicated for use in pelvic reconstruction, acetabular reconstruction, cement restriction, and in long bone procedures such as femoral and humeral reconstruction.

• How is the Hedrocel Trabecular Metal Reconstruction System supplied?

  The device is supplied as a Class II medical device with special controls under product code JDK. It is manufactured by Implex Corp. in Allendale, New Jersey, and is designed for use in various orthopaedic reconstruction procedures.

• What is the regulatory status of the Hedrocel Trabecular Metal Reconstruction System?

  The Hedrocel Trabecular Metal Reconstruction System received FDA 510(k) clearance on November 19, 2003, with K number K033384. It is classified as a Class II medical device with special controls under product code JDK.

• Is the Hedrocel Trabecular Metal Reconstruction System reusable or single-use?

  The device data does not specify whether the Hedrocel Trabecular Metal Reconstruction System is reusable or single-use. This information would typically be found in the device's instructions for use or labeling, which are not provided in the available data.