Hedrocel Vertebral Body Replacement, Models 06-112-00XX2 and 06-132-10XX2

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

510(k) Number

K021967 ↗

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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  FDA 510(k) K012507 Active Cleared 30 Aug 2001

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

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  FDA 510(k) K022563 Active Cleared 30 Aug 2002

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  FDA 510(k) K031449 Active Cleared 23 Sep 2003

• Implex Continuum Porous Patellar

  Class II

  FDA 510(k) K971789 Active Cleared 24 Jul 1997

• Implex Hep Acetabular Revision Cup, Cemented or Cementless Model A-240 System

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  FDA 510(k) K980486 Active Cleared 14 Apr 1998

See all devices from Implex Corp. →

• What specific spinal regions can the Hedrocel Vertebral Body Replacement be used to treat, and why is this device designed for those areas?

  The Hedrocel Vertebral Body Replacement is designed for the thoracolumbar spine, covering vertebrae from T1 to L5. This region is commonly affected by degenerative diseases, trauma, or tumors that compromise vertebral integrity, making structural replacement critical to restore spinal alignment and stability in these mid-to-lower back segments.

• Are the Hedrocel models 06-112-00XX2 and 06-132-10XX2 reusable or single-use, and what does that mean for surgical planning?

  These models are explicitly intended for single-use only, supplied sterile to ensure patient safety and infection control. This means each device must be discarded after one surgical procedure, requiring hospitals to account for inventory turnover and sterilization of surgical tools rather than reprocessing the implant itself.

• How should the Hedrocel Vertebral Body Replacement be stored, and what precautions should be taken given its sterile packaging?

  The device must be stored in accordance with standard orthopedic implant guidelines, which typically include keeping it in its sterile packaging until immediately before use. Storage should follow manufacturer instructions to prevent contamination—usually in a clean, dry environment away from direct sunlight or extreme temperatures, as with other sterile surgical implants.

• What does the FDA’s classification under product code MQP (Class II Special Controls) imply about the oversight and safety standards for this device?

  The MQP product code under Class II Special Controls means the Hedrocel device is subject to additional FDA scrutiny beyond general Class II devices. This includes mandatory premarket notification (510(k)) clearance, post-market surveillance, and compliance with special controls like performance standards or labeling requirements to ensure its safety and effectiveness for spinal replacement procedures.