TrellOss®-C Porous Ti Interbody System

Description

The TrellOss Porous Ti Interbody System is a collection of additively manufactured spacers for cervical, lumbar/ lumbosacral and thoracolumbar implantation. The basic shape of these implants is a structural column to provide surgical stabilization of the spine. Each device comprises an external structural frame having a roughened surface (~7μm). The intervening geometric lattices have pores 300-700μm. The inferior/superior aspects of the TrellOss open devices incorporate a large vertical cavity which can be packed with bone graft material. The open and solid devices are available in an assortment of height, length, width and lordotic angulation combinations to accommodate the individual anatomic and clinical circumstances of each patient.

Indications

• When used as a cervical intervertebral fusion device, the TrellOss-C Porous Ti Interbody System open devices are indicated for use at up to two contiguous levels in the cervical spine, from C2-T1, in skeletally mature patients who have had six weeks of non-operative treatment for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and with supplemental fixation.
• When used as a lumbar intervertebral fusion device, the TrellOss-TS Porous Ti Interbody System open devices are indicated for use at one or two contiguous levels in the lumbar spine, from L2-S1, in skeletally mature patients who have had six months of non-operative treatment for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Additionally, the TrellOss Porous Ti Interbody System lumbar implants can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. The device is intended for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and with supplemental fixation.
• When used as a vertebral body replacement device, the TrellOss Porous Ti Interbody System open and solid devices are indicated for use in the thoracolumbar spine (T1-L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors or trauma/fracture in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The device is intended for use with autograft or allograft and with supplemental internal fixation.

Contraindications

The TrellOss Porous Ti Interbody System contraindications include, but are not limited to:

• The presence of infection, pregnancy, metabolic disorders of calcified tissues, grossly distorted anatomy, inadequate tissue coverage, any demonstrated allergy or foreign body sensitivity to any of the implant materials, drugs/alcohol abuse, mental illness, general neurological conditions, immunosuppressive disorders, obesity, patients who are unwilling to restrict activities or follow medical advice, and any condition where the implants interfere with anatomical structures or precludes the benefit of spinal surgery.
• Biological factors such as smoking, use of nonsteroidal anti-inflammatory agents, the use of anticoagulants, etc. all have a negative effect on bony union. Contraindications may be relative or absolute and must be carefully weighed against the patient’s entire evaluation.
• Any condition not described in the Indications for Use.
• Prior fusion at the level(s) to be treated.

• Mixing of dissimilar metals can accelerate the corrosion process. Stainless steel and titanium implants must NOT be used together in building a construct.
• The TrellOss Porous Ti Interbody System devices should be implanted only by surgeons who are fully experienced in the use of such implants and the required specialized spinal surgery techniques. Prior to use, surgeons should be trained in the surgical procedures recommended for use of these devices.
• The correct selection of the implant is extremely important. The potential for success is increased by the selection of the proper size, shape and design of the implant. Based on the dynamic testing results, the physician should consider the levels of implantation, patient weight, patient activity level, other patient conditions, etc., which may impact on the performance of the device.
• The TrellOss solid devices are not intended for interbody fusion as bone growth through the device has not been demonstrated.
• These devices are provided as single use only implants and are not to be reused or reimplanted regardless of an apparent undamaged condition.
• The TrellOss Porous Ti Interbody System is used to augment the development of a spinal fusion by providing temporary stabilization. This device is not intended to be the sole means of spinal support – supplemental internal fixation must be used. If fusion is delayed or does not occur, material fatigue may cause breakage of the implant. Damage to the implant during surgery (i.e., scratches, notches) and loads from weight bearing and activity will affect the implant’s longevity.
• The correct handling of the implant is extremely important. Use care in handling and storage of devices. Store the devices in a clean, dry area away from radiation and extreme temperatures and corrosive environments such as moisture, air, etc.
• Patients with previous spinal surgery at the level(s) to be treated may have different clinical outcomes compared to those without a previous surgery.
• Components of this system should not be used with components of any other system or manufacturer.
• Potential risks identified with the use of this system, which may require additional surgery, include: device component breakage, loss of fixation/loosening, non-union, vertebral fracture, neurologic, vascular or visceral injury.

Potential complications and adverse effects for this system are similar to those of other spinal instrumentation systems and include, but are not limited to: pseudarthrosis, insufficient bone stock, painful bursa, pressure necrosis, palpable components, early or late loosening of the components; disassembly, bending or breakage of any or all of the components; foreign body (allergic) reaction to the implants; infections possible requiring removal of devices; loss of neurological function, including paralysis, spinal cord impingement or damage.

USA: 720-894-9016

To submit a complaint, please email SpineComplaints@highridgemedical.com

10225 Westmoor Dr. Westminster, CO 80021 USA

To obtain a copy of the current Instructions for Use (IFU) for full prescribing and risk information, please call 720-894-9016.

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4. Rao PJ, Pelletier MH, Walsh WR, et al. Spine Interbody Implants: Material Selection and Modification, Functionalization and Bioactivation of Surfaces to Improve Osseointegration. Orthop Surg 2014;6:81 -89.
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6. Li JP, Habibovic P, et al.: Bone ingrowth in porous titanium implants produced by 3D fiber deposition. Biomaterials 2007;28:2810.
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Nexxt Spine, LLC

14425 Bergen Blvd, Suite B

Noblesville, IN 46060