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About this product

Division: Spine
Category: Interbody Fusion

The CONCORDE™ Bullet Device 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 Device product line.  
The key feature of the CONCORDE Bullet Interbody Cage is the bulleted nose for ease of insertion into the interbody space.  Manufactured from Carbon Fibre Reinforced Polymer (CFRP), CONCORDE Bullet offers optimized area for bone graft and tantalum markers also allow you to visualize the position of the cage in situ. CONCORDE Bullet is designed for surgeons who prefer a straight, oblique placement of the implant and is intended to be used with supplementary posterior instrumentation.

Intended Use


CAUTION: Federal (USA) Law restricts this device to sale by or on the order of a physician (or properly licensed practitioner) who has appropriate training or experience.

The CONCORDE™, CONCORDE Bullet, CONCORDE Curve, COUGAR®, DEVEX®, and LEOPARD® Systems are 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 (CONCORDE, CONCORDE Bullet), TLIF (CONCORDE, CONCORDE Bullet, CONCORDE Curve, DEVEX, LEOPARD Systems) or anterior (COUGAR Systems) 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, CONCORDE Bullet, CONCORDE Curve, COUGAR, DEVEX, and LEOPARD Systems are indicated for use in the thoracolumbar spine (i.e., T1-L5) to replace a diseased vertebral body resected or excised for the treatment of tumours, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. These systems are also indicated for treating fractures of the thoracic and lumbar spine. These systems are 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 these systems are intended for use with DePuy Synthes Spine supplemental internal fixation products.
  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 orthopaedic 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.
WARNINGS: In the USA, this product has labelling limitations. See package insert for complete information.
  1. CORRECT SELECTION OF THE IMPLANT IS EXTREMELY IMPORTANT. The potential for satisfactory anterior column support is increased by the selection of the proper size device. While proper selection can help minimize risks, the size and shape of human bones present limitations on the size, shape and strength of implants. Internal fixation devices cannot withstand activity levels equal to those placed on normal healthy bone. No implant can be expected to withstand indefinitely the unsupported stress of full weight bearing.
  2. IMPLANTS CAN BREAK WHEN SUBJECTED TO THE INCREASED LOADING ASSOCIATED WITH DELAYED UNION OR NONUNION. Internal fixation appliances are load sharing devices that are used to obtain an alignment until normal healing occurs. If healing is delayed, or does not occur, the implant may eventually break due to material fatigue. The degree or success of union, loads produced by weight bearing, and activity levels will, among other conditions, dictate the longevity of the implant. Notches, scratches or bending of the implant during the course of surgery may also contribute to early failure. Patients should be fully informed of the risks of implant failure.
  3. MIXING METALS CAN CAUSE CORROSION. There are many forms of corrosion damage and several of these occur on metals surgically implanted in humans. General or uniform corrosion is present on all implanted metals and alloys. The rate of corrosive attack on metal implant devices is usually very low due to the presence of passive surface films. Dissimilar metals in contact, such as titanium and stainless steel, accelerate the corrosion process of stainless steel and more rapid attack occurs. The presence of corrosion often accelerates fatigue fracture of implants. The amount of metal compounds released into the body system will also increase. Internal fixation devices, such as rods, hooks, wires, etc., which come into contact with other metal objects, must be made from like or compatible metals.
  1. SURGICAL IMPLANTS MUST NEVER BE REUSED. An explanted implant should never be reimplanted. Even though a device appears undamaged, it may have small defects and internal stress patterns that may lead to early breakage. Reuse can compromise device performance and patient safety. Reuse of single use devices can also cause cross-contamination leading to patient infection.
  2. Correct Handling of the Implant is Extremely Important.
    A. Composite Implants: Polymer/carbon-fibre implants are designed to support physiologic loads. Excessive torque, when applied to long-handle insertion tools, can cause splitting or fracture of the polymer/carbon-fibre implants. When a polymer/carbon-fibre implant is impacted or hammered into place, the broad surface of the insertion tool should be carefully seated fully against the implant. Impaction forces applied directly to a small surface of the implant could cause fracture of the implant. Split or fractured implants should be removed and replaced. Implants can break when subjected to the increased loading associated with delayed union or non-union.
    Metal Implants: Contouring of metal implants should only be done with proper equipment. The operating surgeon should avoid notching, scratching or reverse bending of the implants when contouring.
  3. Removal of Supplemental Fixation After Healing. If the supplemental fixation is not removed following the completion of its intended use, any of the following complications may occur: (1) Corrosion, with localized tissue reaction or pain; (2) Migration of implant position resulting in injury; (3) Risk of additional injury from postoperative trauma; (4) Bending, loosening, and/or breakage, which could make removal impractical or difficult; (5) Pain, discomfort, or abnormal sensations due to the presence of the device; (6) Possible increased risk of infection; and (7) Bone loss due to stress shielding. The surgeon should carefully weigh the risks versus benefits when deciding whether to remove the implants. Implant removal should be followed by adequate postoperative management to avoid refracture. If, for example, the patient is older and has a low activity level, the surgeon may choose not to remove the implant thus eliminating the risks involved with a second surgery.
  4. Adequately Instruct the Patient. Postoperative care and the patient’s ability and willingness to follow instructions are among the most important aspects of successful bone healing.
    The patient must be made aware of the limitations of the implants. The patient should be encouraged to ambulate to tolerance as soon as possible after surgery, and instructed to limit and restrict lifting and twisting motions and any type of sports participation until the bone is healed. The patient should understand that implants are not as strong as normal healthy bone and could loosen, bend and/or break if excessive demands are placed on it, especially in the absence of complete bone healing. Implants displaced or damaged by improper activities may experience migration and damage nerves or blood vessels.
  5. Cauterization Near the Implant: When performing cauterization around an implant, care should be taken to avoid contact with the implant.
  6. Patients with Previous Surgery. Patients with previous spinal surgery at the level(s) to be treated may have different clinical outcomes compared to those without a previous surgery.


Features & Benefits


  Features Benefits
Bulleted nose easier to insert Significantly lower maximum insertion force into tight disc spaces

Resists migration

Sizing options to match patient anatomy

Pyramidal teeth

Significantly greater resistance to anterior

Available lordotic options
1mm height increments
Total of 26 sizing options

Prevents migration

CFRP composition Strength and stiffness similar to cortical bone allows for open architecture optimizing graft volume
Tantalum markers Three markers allows for verification of placement and positioning


CA20232A; V0770A
Please refer to the surgical technique guide or package inserts if included for a complete list of indications, contraindications, precautions and warnings. For further information on DePuy Synthes Products, please contact your local DePuy Synthes Representative .
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