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 thoroughly knowledgeable in the implant's material and surgical aspects and who has been instructed as to its mechanical and material applications and limitations.
The CAPSTONE PTC™ Spinal System consists of commercially pure titanium (CP Ti) coated PEEK cages of various widths and heights, which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar 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.
No warranties express or implied, are made. Implied warranties of merchantability and fitness for a particular purpose or use are specifically excluded.
The CAPSTONE PTC™ Spinal System is indicated for interbody fusion in patients with Degenerative Disc Disease (DDD) at one or two levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.
Additionally, the CAPSTONE PTC™ Spinal System is indicated to assist in the setting of spinal deformity as a supplement to pedicle screw fixation in patients diagnosed with degenerative scoliosis.
These implants may be implanted via an open or a minimally invasive posterior approach. Alternatively, these implants may also be implanted via an anterior and/or transforaminal approach. These implants are to be used with autogenous bone graft and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate.
These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the Food and Drug Administration (FDA) for use in the lumbar spine.
This device is not intended for cervical spine use. Contraindications 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:
Adverse effects may occur when the device is used either with or without associated instrumentation. The potential risk of adverse effects as a result of movement and non-stabilization may increase in cases where associated complementary support is not employed. Potential adverse events include, but are not limited to:
A device that has been implanted should never be reused, reprocessed, or resterilized under any circumstances. Sterile packaged devices should also never be resterilized. Reuse, reprocessing, or resterilization may compromise the structural integrity of these implants and create a risk of contamination of the implants which could result in patient injury, illness, or death.
When used in deformity procedures, undersizing the implant may limit endplate engagement and potentially lead to implant migration and/or expulsion.
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 without autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone or in cases that do not develop a union will not be successful.
Preoperative and operating procedures including knowledge of surgical techniques, good reduction, and correct selection and placement of the implants are important considerations in the successful utilization of the system by the surgeon. Further, the proper selection and the compliance of the patient will greatly affect the results. Patients who smoke have been shown to have a reduced incidence of bone fusion. These patients should be advised of this fact and warned of this consequence. Obese, malnourished, or alcohol/drug abuse patients, and those with poor muscle and bone quality and nerve paralysis are also poor candidates for spinal fusion.
Patients with previous spinal surgery at the levels to be treated may have different clinical outcomes compared to those without a previous spinal surgery.
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.
For US audiences only
Caution: federal law (USA) restricts these devices to sale by or on the order of a physician.