Gallery™ Laminoplasty Spine System

Description

The Gallery Laminoplasty Fixation System is a plate and screw system fabricated from titanium alloy (Ti-6Al-4V ELI) and CP Titanium. Various instruments are available to facilitate implantation of the device. The aims of the Gallery Laminoplasty Fixation System are to maintain an expanded spinal canal, secure stability of the lamina, and help preserve the protective function of the spine after a laminoplasty has been performed. The Gallery Laminoplasty Fixation System plates are available in different designs, sizes, and bends to allow for different patient anatomy. Plate lengths correspond with allograft lengths.

Indications

The Gallery Laminoplasty Fixation System is intended for use in the lower cervical and upper thoracic spine (C3-T3) after a laminoplasty has been performed. The Gallery Laminoplasty Fixation System holds or buttresses the allograft in place in order to prevent the allograft from expulsion or impinging on the spinal cord.

Contraindications

The Gallery Laminoplasty Fixation System is not to be used:

• For screw attachment or fixation to the posterior elements of the lumbar spine

• For single-level or two-level spondylosis without developmental spinal canal stenosis

• Under any direct load bearing conditions

• In the presence of focal anterior compression

• In the presence of isolated radiculopathy
• In the presence of loss of anterior column support resulting from tumor, trauma, or infection site.

Other Standard Contraindications Include:

• Spinal infection or inflammation

• Morbid obesity

• Mental illness, alcoholism, or drug abuse

• Pregnancy

• Metal sensitivity/foreign body sensitivity

• Patients with inadequate tissue coverage over the operative site

• Open wounds local to the operative area

• Rapid joint disease, bone absorption, osteopenia and/or osteoporosis.

Warnings:

• This device is not approved for screw attachments to the posterior elements of the lumbar spine.

• Allograft must always be used with the Gallery Laminoplasty Fixation System plates.

• Selection of Implants. Selection of proper size, shape and design of the implant increase the potential for success. While proper selection can help minimize risks, the size and shape of human bones present limitations on the size and strength of implants.

• Implant Strength and Loading. These devices are not designed to withstand the unsupported stress of full weight bearing and/or load bearing, and cannot withstand activity levels and/or loads equal to those placed on normal healthy bones. If healing is delayed or does not occur, the implant could eventually break due to metal fatigue. Loads produced by weight bearing and activity levels will dictate the longevity of the implant.

• Corrosion. Contact of dissimilar metals accelerates the corrosion process, which could enhance fatigue fracture of the implants. Therefore, only use like or compatible metals with implants that are in contact with each other.

• The Gallery Laminoplasty Fixation System has not been evaluated for safety and compatibility in the MR environment. The Gallery Laminoplasty Fixation System has not been tested for heating or migration in the MR environment.

Precautions

• Single Use Only. Do not reuse implants/devices. While an implant/device may appear undamaged, previous stress may have created imperfections that would reduce the service life of the implant/device. Do not treat patients with implants/devices that have been even momentarily placed in or used on a different patient.

• Handling of Implants. Titanium implants are to be handled with care. If contouring of the plate is required, avoid sharp bends and reverse or repetitive bends. Avoid notching or scratching of the device, which could produce internal stresses and lead to early breakage. Avoid bending across the screw holes.

• Implant Removal After Healing. After healing is complete, the implant may be removed since it is no longer necessary. Implants that are not removed may result in complications such as implant loosening, fracture, corrosion, migration, pain or stress shielding of bone, particularly in young, active patients. Implant removal should be followed by adequate postoperative management.

• Adequate Patient Instructions. A patient must be instructed on the limitations of the metallic implant, and should be cautioned regarding physical activity and weight bearing or load bearing prior to complete healing.

USA: 720-894-9016

To submit a complaint, please email SpineComplaints@highridgemedical.com

10225 Westmoor Dr. Westminster, CO 80021 USA

To obtain a copy of the current Instructions for Use (IFU) for full prescribing and risk information, please call 720-894-9016.

Zimmer Biomet Spine, Inc.

10225 Westmoor Dr.

Westminster, CO 80021 USA