CONCORDE® Bullet Lumbar Interbody System

Division: Spine
Category: Lumbar Degenerative

The CONCORDE® Bullet Lumbar Interbody System was designed for MIS and open TLIF procedures to facilitate ease of insertion and improved resistance to migration while maintaining the proven clinical benefits of the existing CONCORDE System. 

The key feature of the CONCORDE Bullet System is the bulleted nose for ease of insertion into the interbody space. Available in carbon fiber reinforced polymer (CFRP) and Titanium, the CONCORDE Bullet System offers optimized area for bone graft and tantalum markers (for CFRP) also allow you to visualize the position of the cage in situ. The CONCORDE Bullet System is designed for surgeons who prefer a straight, oblique placement of the implant and is intended to be used with supplementary posterior instrumentation.

Indications for Use

INDICATIONS
 

CONCORDE Bullet System

The CONCORDE Bullet System is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Additionally, the CONCORDE Bullet System can be used in patients diagnosed with spinal deformities as an adjunct to fusion. These patients should be skeletally mature and have undergone six months of non-operative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine and are placed via either a PLIF or TLIF approach using autogenous bone and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. When used as an interbody fusion device these implants are intended for use with DePuy Spine supplemental internal fixation products.

 

The CONCORDE Bullet System is indicated for use in the thoracolumbar spine (i.e., T1-L5) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. This system is also indicated for treating fractures of the thoracic and lumbar spine. This system is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. When used as a vertebral body replacement device this system is intended for use with DePuy Spine supplemental internal fixation products.

 

CONCORDE Bullet Titanium

The CONCORDE Bullet Spinal System is indicated for use as intervertebral body fusion devices in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Patients should have six months of non-operative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine and are placed via either a PLIF or TLIF approach using autogenous bone. When used as interbody fusion devices, these implants are intended for use with DePuy Spine supplemental internal fixation products.

 

The CONCORDE Bullet Spinal System is indicated for use in the thoracolumbar spine (i.e., T1-L5) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore height of a collapsed vertebral body. This system is also indicated for treating fractures of the thoracic and lumbar spine. This system is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period. When used as a vertebral body replacement device, this system is intended for the use with DePuy Spine supplemental internal fixation products.

 

CONTRAINDICATIONS

1. Use of these systems is contraindicated when there is active systemic infection, infection localized to the site of the proposed implantation, or when the patient has demonstrated allergy or foreign body sensitivity to any of the implant materials.

2. Severe osteoporosis or osteopenia may prevent adequate fixation and thus preclude the use of these or any other orthopedic implants.

3. Conditions that may place excessive stresses on bone and implants, such as severe obesity, pregnancy or degenerative diseases, are relative contraindications. The decision to use these devices in such conditions must be made by the physician taking into account the risks versus the benefits to the patient.

4. Use of these implants is relatively contraindicated in patients whose activity, mental capacity, mental illness, alcoholism, drug abuse, occupation, or lifestyle may interfere with their ability to follow postoperative restrictions and who may place undue stresses on the implant during bony healing and may be at a higher risk of implant failure.

5. Prior fusion at the level(s) to be treated.

6. Any condition not described in the Indications for Use.

 

 

WARNING: This product has labeling limitations. See package insert for additional warnings, precautions and possible adverse effects.

CAUTION: USA law restricts this device to sale by or on the order of physician.

Features & Benefits

 

     
CONCORDE Bullet Lumbar Interbody System Trail Insertion | DePuy Synthes Companies

CONCORDE Bullet Lumbar Interbody System carbon fiber reinforced polymer | DePuy Synthes Companies

CONCORDE Bullet Lumbar Interbody System axial cage insertion | DePuy Synthes Companies

CONCORDE Bullet Lumbar Interbody System x-ray | DePuy Synthes Companies

Bulleted nose  Designed to lower maximum insertion force into tight disc spaces
Resists migration Designed to offer greater resistance to anterior migration
Sizing options to match patient anatomy

Available lordotic options

 

1mm height increments

 

Total of 26 sizing options

Pyramidal teeth

Offer resistance to migration

CFRP composition

Strength and stiffness similar to cortical bone

 

Allows for open architecture optimizing graft volume

Tantalum markers (only in CFRP option)

Three markers allows for verification of placement and positioning

 

DSUS/SPN/0416/1254 04/2016

All medical devices have associated risks. Please refer to the package insert and other labeling for a complete list of indications, contraindications, precautions and warnings. For further information on DePuy Synthes Products, please contact your local DePuy Synthes Representative.