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Zimmer, Inc.

TM-S Cervical Fusion Device

Product Description

This cervical fusion device provides an excellent balance between porosity and strength. TM-S is the only cervical spinal implant made with Trabecular Metal Material. It offers a high coefficient of friction to help prevent device migration and expulsion, as well as a low modulus of elasticity that may improve load-sharing, which potentially minimizes stress-shielding. With its average porosity of up to 80% and a consistent open pore structure, the material is also designed to resemble the structure and mechanical properties of cancellous bone, which provides an excellent environment for boney in-growth and vascularization.

Features

  • Average porosity of up to 80% with a consistent, open pore structure designed to resemble the physical and mechanical properties of cancellous bone
  • Low modulus of elasticity that may improve load-sharing, which potentially minimizes stress-shielding
  • High coefficient of friction to prevent device migration and expulsion

 

ZS-OUS0050-04

No other porous material so closely resembles the structure, function and physiology of trabecular bone.

Trabecular Metal Material is a highly porous structure with a nano-textured strut architecture that creates an initial scratch fit and facilitates the long-term biologic attachment of orthopaedic implants via the potential for bone ingrowth. Trabecular Metal Material is the most advanced fixation surface available for orthopaedic implants. Clinical use since 1997 demonstrates that this innovative technology provides excellent initial scratch fit and the potential for stable, long-term fixation. No other porous metal material so closely resembles the structure, function and physiology of cancellous bone.

Learn more about Trabecular Metal Technology at tmt.zimmer.com.

Trabecular Metal has a coefficient of friction of .98 against cancellous bone. This produces a good “scratch fit” and increases the material’s initial fixation and stability to bone. Good initial fixation secures the implant in place, allowing time for bone ingrowth.

Trabecular Metal Material had more than 10 years of clinical results and has been used in over 200,000 orthopedic cases worldwide.

Device Description

The TM-S Fusion Device is a single device manufactured wholly from Trabecular Metal porous tantalum. The device is a trapezoidal shape and is available in a variety of cross-sectional geometries and sizes. It is offered in a 7° included angle option and a 0° included angle option to help maintain the natural contour of the spine.

The superior and inferior surfaces of the device have a textured surface to provide increased stability. It has a central hole extending in the superior-inferior direction for placement of autogenous bone graft. The device also has a small slot on its anterior face for mating with its insertion instrument. The height is measured at the posterior aspect of the device.

These implants are intended for single use only and must not be reused under any circumstances. Surgical instruments are also available to assist in the implantation of the device.

Indications

The TM-S Fusion Device is a cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with/without radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The TM-S device is intended for use with supplemental fixation systems and with autogenous bone graft. The TM-S Fusion Device is implanted via an anterior approach.

Contraindications

  1. Active local infection in or near the operative region.
  2. Active systemic infection and/or disease.
  3. Severe osteoporosis or insufficient bone density, which in the medical opinion of the physician precludes surgery or contraindicates instrumentation.
  4. Spinal conditions other than cervical DDD.
  5. Prior surgical procedure using the desired operative approach.
  6. Current metastatic tumors of the vertebrae adjacent to the implant.
  7. Known or suspected metal sensitivity.
  8. Endocrine or metabolic disorders known to affect osteogenesis (e.g., Paget's disease, renal osteodystrophy, hypothyroidism).
  9. Systemic disease that requires the chronic administration of nonsteroidal anti-inflammatory or steroidal drugs.
  10. Significant mental disorder or condition that could compromise the patient's ability to remember and comply with preoperative and postoperative instructions (e.g., current treatment for a psychiatric/psychosocial disorder, senile dementia, Alzheimer's disease, traumatic head injury).
  11. Neuromuscular disorder that would engender unacceptable risk of instability, implant fixation failure, or complications in postoperative care. Neuromuscular disorders include spina bifida, cerebral palsy, and multiple sclerosis.
  12. Pregnancy.
  13. Patients unwilling to follow postoperative instructions, especially those in athletic and occupational activities.
  14. Morbid obesity.
  15. Symptomatic cardiac disease.
  16. Skeletal immaturity.
  17. Grossly distorted anatomy.
  18. Conditions other than those indicated.

Warnings

  1. Surgery is not always successful. Preoperative symptoms may not be relieved or may worsen. Surgical knowledge of the procedure and the device are important, as is patient selection. Patient compliance is also important. Tobacco and alcohol abuse may lead to unsuccessful results.
  2. Reuse of a single use device that has come in contact with blood, bone, tissue or other body fluids may lead to patient or user injury. Possible risks associated with reuse of a single use device include, but are not limited to, mechanical failure and transmission of infectious agents.
  3. Appropriate device selection is crucial to obtain proper fit and to decrease the stress placed on the implant.
  4. Components of competitive spinal systems should not be used with the TM-S Fusion Device.
  5. Delayed healing can lead to fracture or breakage of the implants due to increased stress and material fatigue. Patients must be fully informed of all the risks associated with the implant and the importance of following postoperative instructions regarding weight bearing and activity levels to facilitate proper bone growth and healing.
  6. The implant must be handled carefully following the manufacturer’s instructions to prevent damage to the implant.
  7. Implants must not be modified or otherwise processed in any way.
  8. Care must be taken to avoid using dissimilar metals in contact with one another as corrosion may occur. Additional fixation instrumentation that is used to stabilize the affected level must be made of compatible materials, such as titanium or titanium alloy. Corrosion may accelerate metal fatigue and lead to failure of the implant.
  9. Once a device has been implanted, it must never be reused. If the package is damaged or opened but the device is not used, or if the expiration date has passed, the device must be returned to Zimmer. The device must not be resterilized by the end user.
  10. The surgeon must be familiar with the appropriate technique to implant the supplemental internal fixation and the appropriate hardware.
  11. MRI Compatibility

    11.1.  The patient must be told that implants can affect the results of computer tomography (CT) or magnetic resonance imaging (MRI) scans.
    11.2.  The TM-S Fusion Device has not been evaluated for safety or compatibility in the MR environment.
    11.3.  The TM-S Fusion Device has not been tested for heating or migration in the MR environment.

  12. This surgical procedure requires the use of supplemental fixation systems to stabilize the fusion site.

Precautions

Surgeon Precautions

  1. The implantation of an intervertebral body fusion device should be performed only by experienced spinal surgeons with specific training in the use of this device because this is a technically demanding procedure presenting a risk of serious injury to the patient.
  2. The surgeon must have a thorough knowledge of the mechanical and material limitations of surgical implants made of Trabecular Metal and be thoroughly familiar with the surgical technique for implanting the TM-S Fusion Device for the given Indications for Use.
  3. Based on the fatigue testing results, the physician/surgeon should consider the level of implantation, patient weight, patient activity level, other patient conditions, etc. which may impact on the performance of the system.
  4. The surgeon should be familiar with the various devices and instruments and verify that all are available before beginning the surgery. Additionally, the packaging and implant should be inspected for damage prior to implantation.
  5. In the event that removal of the implant is considered (e.g. due to loosening, fracture, migration of the implant; infection; increased pain, etc.), the risks versus benefits must be carefully weighed. Such events can occur even after healing, especially in more active patients. Appropriate postoperative care must be given following implant removal to avoid further complication.
  6. The surgeon must be