This device is a fusion device intended for stabilization 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 instructed as to its mechanical and material applications and limitations.
The ARTiC-L™ 3D Ti Spinal System with TiONIC™ technology consists of additive manufactured titanium cages of various widths, lengths, heights, and lordotic angles to accommodate patient anatomy. These devices can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The articulating device assembly allows for placement of implant while remaining attached to inserter. The open geometry of the implants allows them to be packed with 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 device is not intended to be used as a stand-alone implant.
Stainless steel and titanium implants are not compatible. They must not be used together in a construct. As with all orthopedic implants, in no case may the implants be re-used.
No warranties, express or implied, are made. Implied warranties of merchantability and fitness for a particular purpose or use are specifically excluded.
The ARTiC-L™ 3D Ti Spinal System with TiONIC™ technology is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (DDD - defined by 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 ARTiC-L™ 3D Ti Spinal System with TiONIC™ technology can be used in patients diagnosed with spinal deformities as an adjunct to fusion. These patients should be skeletally mature and have undergone 6 months of non-operative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine 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.
When used as an interbody fusion device, these implants are intended for use with supplemental internal fixation systems.
This device is not intended for cervical spine use. Contraindications include:
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 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:
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 bone graft 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 implants are important considerations in the successful use of the system by the surgeon. Further, proper selection and compliance of the patient will greatly affect the results. Patients who smoke were shown to have a reduced incidence of bone fusion. These patients should be advised of this fact and warned of this consequence. Obese, malnourished, and/or alcohol/drug abuse patients and those with poor muscle and bone quality and/or 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.
A device that has been implanted should never be re-used or re-processed under any circumstances. Sterile packaged devices are never to be re-sterilized. Re-use or reprocessing may compromise the structural integrity of the implants and create a risk of contamination of the implants.
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.