This device is a fusion device intended for stabilization use and to promote bone fusion during the normal healing process following surgical correction of disorders of the spine. The product should be implanted only by a physician who is thoroughly knowledgeable in the implant’s material and surgical aspects and who has been instructed as to its mechanical and material applications and limitations. This device is manufactured from medical grade polyetheretherketone (PEEK), tantalum markers, a commercially pure titanium (CP Ti) coating, and is provided sterile.
The ANATOMIC PEEK™ PTC Cervical Fusion System consists of cages of various widths and heights which can be inserted between two cervical vertebral bodies to give support and correction during cervical interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The ANATOMIC PEEK PTC devices must be used with supplemental fixation. No warranties, express or implied, are made. Implied warranties of merchantability and fitness for a particular purpose or useare specifically excluded. Medical grade tantalum, medical grade CP Ti, and medical grade PEEK may be used together. Never use titanium or titanium alloy implants with stainless steel in the same construct.
The ANATOMIC PEEK PTC Cervical Fusion System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level or two contiguous levels. DDD isdefined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies.
The ANATOMICPEEK PTC Cervical Fusion System is used to facilitate intervertebral body fusion in the cervical spine and is placed via ananterior approach from the C2-C3 disc space to the C7-T1 disc space using autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate.
The ANATOMIC PEE PTC Cervical Fusion System is to be used with supplemental fixation. Patients should have at least six weeks of non-operative treatment prior to treatment with an intervertebral cage.
The ANATOMIC PEEK PTC device is not intended for posterior surgical implantation. Contraindications also include, but are not limited to:
Nota bene: Although not absolute contraindications, conditions to be considered as potential factors for not using this device include:
All of the possible adverse events or complications associated with spinal fusion surgery without instrumentation are possible. With instrumentation, a listing of possible adverse events or complications includes, but is not limited to:
Note: additional surgery may be necessary to correct some of these anticipated adverse events.
This system was designed for single patient use only. Do not reuse, reprocess, or resterilize this product. Reuse, reprocessing, or resterilization may compromise the structural integrity of the device and/or create a risk of contamination of the device, which could result in patient injury, illness, or death.
A successful result is not always achieved in every surgical case. This fact is especially true in spinal surgery where other patient conditions may compromise the results. Use of this product in cervical interbody fusion procedures without autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft may not be successful. No spinal implant can withstand body loads without the support of bone. In this event, bending, loosening, disassembly, and/or breakage of the device(s) will eventually occur.
Preoperative and operating procedures including knowledge of surgical techniques, proper selection and place-ment of the implant, and good reduction are important considerations in the success of surgery.
Patients with previous spinal surgery at the levels to be treated may have different clinical outcomes compared to those without a previous surgery This system should not be used in any case not described in the indications.
Further, the proper selection and compliance of the patient will greatly affect the results. Patients who smoke have been shown to have an increased incidence of non-unions. These patients should be advised of this fact and warned of this consequence. Obese, malnourished, and/or alcohol abuse patients are also poor candidates for spine fusion.
Physician note: Although the physician is the learned intermediary between the company and the patient, the important medical information given in this document should be conveyed to the patient. Based on fatigue testing results, when using the ANATOMIC PEEK™ PTC Cervical Fusion System, the physician/ surgeon should consider the levels of implantation, patient weight, patient activity level, other patient conditions, etc. which may impact the performance of this system.
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Caution: federal law (USA) restricts these devices to sale by or on the order of a physician.