Hydrocel Vertebral Body Replacement, Model 06-172-00XX1

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

510(k) Number

K022563 ↗

FDA Product Code

MQP

Device Class

Class II

Regulation

21 CFR Part 888.3060

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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• Hedrocel Acetabular Restrictor

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See all devices from Implex Corp. →

• What anatomical region is the Hydrocel device intended to treat?

  It is designed for the thoracolumbar spine, replacing diseased or damaged vertebral bodies and adjacent discs in that region. The anterior approach allows direct access to these levels while preserving surrounding structures.

• How is the implant supplied and what are its sterility requirements?

  The device is supplied as a sterile, single‑use implant. Sterility is maintained until the point of use, and the implant is not intended for re‑sterilization or reuse, ensuring consistent performance and infection control.

• What materials compose the Hydrocel vertebral body replacement and why?

  It combines a porous tantalum coating with a vitreous carbon skeleton. Tantalum provides a highly porous, osteoconductive surface for bone ingrowth, while vitreous carbon offers structural strength and biocompatibility, together supporting stable spinal reconstruction.

• What regulatory classification does this device have and what does that imply?

  Classified as a Class II device under FDA 510(k) clearance (K022563) with product code MQP, it is subject to special controls. This means the device must meet specific performance standards and labeling requirements before it can be marketed.