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Zimmer, Inc.

Optio-C® Anterior Cervical System

Product Description

The Optio-C System is the industry's first no profile, modular stand-alone cervical device that offers allograft* and PEEK options and delivers the strength, stability and fusion potential of a traditional ACDF.

No Profile
REDUCES soft tissue irritation for less invasive ACDF procedures
ELIMINATES the need for additional plating when addressing adjacent level disease

No Compromise
STRENGTH:  Plate equivalent to a traditional cervical plate1
STABILITY:  Three screw fixation is designed to reduce segmental motion and interference with existing hardware
FUSION:  Spacer features a load-sharing interface designed to reduce stress shielding

Features

  • Optimize load sharing on spacer:  unique load-sharing interface is designed to promote graft fusion, and variable angle screws are designed to prevent stress shielding

  • Confidence in locking mechanism:  anti-migration system provides tactile and visual confirmation; pre-assembled locking mechanism secures all screws simultaneously

  • PEEK or Allograft* Options:  three footprints to accommodate patient anatomy; Allograft consists of cortical and cancellous bone

  • Proprietary screw performance:  DiamondTip screw technology reduces surgical steps because screw can be placed without a pilot hole2 and cortico-cancellous threads are designed to enhance bone purchase

  • Innovative distraction pins facilitate implantation with existing hardware and accommodate different plate widths and thicknesses

  • Minimally invasive procedure: to minimize exposure, Awls, Drills and Drivers are available in Straight, U-Joint or Flexible configurations, and all Drivers have a unique screw retention feature to accommodate various screw implantation angles

  •  

*Structural allograft/autograft

1 Demonstrated by mechanical testing per ASTM F1717.  Data on file at Zimmer Spine.

2 Comparison of Self-Drilling and Self-Tapping Cervical Spine Screws Using ASTM F543-07.Journal of ASTM International, Vol. I, No 7, July 2011.

ZS-SA0700-41_B

Device Description

The Optio-C Plate is a component of the Optio-C Anterior Cervical System and intended to be used only in anterior surgical procedures.  The Optio-C Plate must be used with three Optio-C bone screws and is designed to be used with either one of the following:

  • one Optio-C Anterior Cervical PEEK Intervertebral Body Fusion (IBF) Spacer or
  • one Optio-C structural allograft or
  • one structural allograft/autograft of the same height

The Optio-C Plate and PEEK IBF Spacer are supplied sterile to the end user. The bone screws and instrumentation are supplied non-sterile and are intended to be sterilized by the end user.  This IFU is specific to the Optio-C Plate. 

The Optio-C Plate is offered in a one-level configuration, with a standard width and multiple heights and is designed to facilitate fusion. The plate with Optio-C PEEK (IBF) Spacer or a structural allograft/autograft is placed in the cervical disc space, flush with the adjacent vertebral bodies. Bone screws pass through the screw holes of the plate and affix to bone to help prevent implant migration. The implant construct can be implanted in two orientations: Standard orientation, two screws cephalic and one screw caudal or Inverted orientation, one screw cephalic and two screws caudal.

The bone screws are offered in a variable-angle design and have a cortical/cancellous thread design. Bone screws are available with both self-drilling and self-tapping tip designs and are available in multiple lengths.

Multiple instruments include, but are not limited to, trials, rasps, and inserters that facilitate the insertion and removal of the Optio-C implants.  Refer to the surgical technique guides for a complete listing and description of all Optio-C instrumentation and detailed instructions for use.

Indications

When Optio-C Anterior Cervical Plate is used with structural allograft/autograft it is intended for one-level anterior screw fixation of the cervical spine (C2-T1).  The implant has been designed for use with structural allograft/autograft to provide stabilization as an adjunct to cervical fusion.   Indications for use of the Optio-C Anterior Plate with structural allograft/autograft include degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), tumor, pseudarthrosis or failed previous fusion. The Optio-C Anterior Cervical Plate is intended to be used with structural allograft/autograft and with three Optio-C bone screws.

When Optio-C Anterior Cervical Plate is used with an Optio-C PEEK IBF Spacer it becomes an Optio-C Anterior Cervical Intervertebral Body Fusion Device (IBFD), indicated for stand-alone anterior cervical interbody fusion procedures in skeletally mature patients with cervical degenerative disc disease at one level from C2 to T1.  Degenerative disc disease (DDD) is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.  The Optio-C IBFD is comprised of one Optio-C PEEK IBF Spacer, one Optio-C Anterior Cervical Plate and three Optio-C bone screws.

The Optio-C IBFD is to be used with autograft and implanted via an open, anterior approach in patients who have had six weeks of non-operative treatment.

Contraindications

  1. Disease conditions which have been shown to be safely and predictably managed without the use of internal fixation devices are relative contraindications to the use of these devices.
  2. Active systemic infection or infections localized to the site of the proposed implantation are contraindications to implantation.
  3. Severe osteoporosis is a relative contraindication because it may increase the occurrence of subsidence.
  4. Any entity or condition that totally precludes the possibility of fusion, i.e. cancer, kidney dialysis or osteopenia, is a relative contraindication.
  5. Obesity
  6. Pregnancy
  7. Certain degenerative disease
  8. Foreign body sensitivity
  9. The patient’s occupation or activity level or mental capacity may be relative contraindications to this surgery.  Specifically, some patients may, because of their occupation or lifestyle, or because of conditions such as mental illness, alcoholism or drug abuse, place undue stresses on the implant.
  10. Metabolic disorders that may impair bone formation.
  11. Inadequate bone stock to support the device.
  12. Poor prognosis for good wound healing (e.g., decubitis ulcer, end-stage diabetes, severe protein deficiency and/or malnutrition).
  13. Known patient sensitivity to device materials (titanium alloy, Ti-6Al-4V ELI or polyetheretherketone [PEEK]).
  14. Use in the posterior elements (pedicles) of the cervical, thoracic, or lumbar vertebrae.
  15. Where attempted correction exceeds the limits of physiological conditions.
  16. Any condition not described in the indications for use.

See also the WARNINGS, PRECAUTIONS and POSSIBLE ADVERSE EFFECTS section.

Warnings

  1. Implants and Instruments should be stored in their original packaging in a dry environment, away from aggressive or oily chemicals.
  2. When inserting the implant, care should be taken to avoid using excessive force which has the potential to cause damage to the implant or surrounding tissue.
  3. When preparing the disc space, care should be taken to ensure an appropriate amount of bone is removed; excessive removal of bone has the potential to cause subsidence while failing to remove enough bone has the potential to cause poor fusion.
  4. During screw insertion, care should be taken to avoid bone screw stripping which has the potential to cause an unstable screw construct. 
  5. Care should be taken when handling the flexible instruments.  Specifically, the flexible tip should be maintained in the guide to prevent soft tissue damage. 
  6. When inserting the implant, ensure a tight fit between the inserter and implant. Release distraction prior to drilling to prevent shifting.
  7. During distraction of the disc space, care should be taken to prevent over-distraction or under-distraction which has the potential to cause irreversible damage to the patient or an unstable implant construct.
  8. If existing hardware is present, compatibility between the distraction pin and the existing hardware should be verified prior to use.  When the distraction pin is used with existing hardware, extreme care should be taken to prevent damage to existing hardware.
  9. Potential risks identified with the use of this device system, which may require additional surgery, include:
    a) Device component fracture.
    b) Loss of fixation.
    c) Non-union.
    d) Neurological injury.
    e) Vascular or visceral injury. 
  10. Do not use this product for other than labeled indications (off-label use).
  11. Components of competitive spinal systems should not be used with the Optio-C Devices.
  12. Patient selection shall consider the following factors which are important to the success of the procedure and the performance of the device:
    a) The patient’s weight. An overweight or obese patient can produce loads on the device that can lead to a loss of interbody height or failure of the device and/or the operation.
    b) The patient’s occupation or activity. If the patient is involved in an occupation or activity that includes substantial walking, running, lifting or muscle strain, the resultant forces can cause loss of disc height and/or failure of the device.
    c) A condition of senility, mental illness, alcoholism, or drug abuse. These conditions, among others, may cause the patient to ignore certain necessary limitations and precautions in the use of the appliance, leading to implant failure or other complications.
    d) Certain degenerative diseases. In some cases, the progression of degenerative disease may be so advanced at the time of implantation that it may substantially decrease the expected useful life of the appliance. For such cases, orthopaedic devices can only be considered a delaying technique or temporary relief.
    e)  Foreign body sensitivity. Where material sensitivity is suspected, appropriate tests should be made prior to material selection or implantation.
    f) Smoking. Patients who smoke have been observed to experience higher rates of pseudarthrosis following surgical procedures where bone graft is used.
  13. Implants can break when subjected to the increased loading associated with delayed union or non-union.  Spinal implants are load sharing devices which are used to obtain an alignment until normal healing occurs. If healing is delayed or does not occur, the implant may eventually break due to fatigue. The degree or success of union, loads produced by weight bearing, and activity levels will, among other conditions, dictate the longevity of the implant. Notches, scratches or bending of the implant during the course of surgery may also contribute to early failure. Patients should be fully informed of the risks of implant failure.
  14. These warnings do not include all adverse effects that can occur with surgery in general. General surgical risks should be explained to the patients prior to surgery.
  15. The Optio-C Anterior Cervical Intervertebral Body Fusion Device (IBFD) is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.
  16. The Optio-C PEEK IBF Spacer is not to be used alone.
  17. The Optio-C Anterior Cervical Plate is not to be used alone, but only with the integrated screws provided and appropriate interbody material per the Indications for Use.

Precautions

It is strongly recommended that the patient be informed of the risks associated with surgical procedures and components:

  1. Surgical implants must never be reused.  An explanted implant should never be re-implanted. Even though the device appears undamaged, it may have small defects and internal stress patterns that may lead to early breakage. Reuse of a single use device that has contacted blood, bone, tissue or other body fluis may lead to patient or user injury.  Risks associated with re-use of single use devices include:
    • Mechanical malfunction
    • Transmission of infectious agents
  2. Based on the fatigue testing results, the physician/surgeon should consider the levels of implantation, patient weight, patient activity level, other patient conditions, etc. which may impact the performance of the system
  3. Adequately instruct the patient.  Postoperative care and the patient’s ability and willingness to follow instructions are one of the most important aspects of successful bone healing. The patient must be made aware of the limitations of the implant and that physical activity and full weight bearing have been implicated in fracture. The patient should understand that an implant is not as strong as normal, healthy bone and will fracture if excessive demands are placed on it in the absence of complete bone healing. An active, debilitated, or demented patient who cannot properly use weight-supporting devices may be particularly at risk during postoperative rehabilitation.
  4. The Optio-C IBFD device should only be used after the spinal surgeon has had training in this method of fixation and has become thoroughly knowledgeable about the spinal anatomy and biomechanics.
  5. The Surgical Technique is not a substitute for training and is for informational purposes only
  6. Carefully read all instructions and be familiar with the Optio-C Anterior Cervical PEEK Interbody System surgical technique prior to use.

 

Possible Adverse Effects

Complications and adverse reactions have been reported with the use of similar spinal instrumentation systems. These adverse effects, including the possibility of death, should be discussed with the patient prior to surgery.

Possible neurologic operative/postoperative adverse reactions that may require medical or surgical intervention (e.g., implant removal with or without re-instrumentation) include:

  • Paralysis, complete or incomplete. Delayed onset has occurred even when evoked potential was unaffected during surgery
  • Dural tear leading to cerebrospinal fluid fistula or pseudo meningocele
  • Other spinal cord injuries not otherwise described due to positioning of the spinal attachment device
  • Laminar erosion
  • Epidural bleeding
  • Abnormal sensations
  • Radiculopathy

Possible device postoperative complications/adverse reactions that may require medical or surgical intervention (e.g., implant removal with or without re-instrumentation) include:

  • Loosening, bending, breaking, disassembly, and/or migration of the components
  • Collapse of a fracture and/or fusion site
  • Device failure
  • Corrosion at the screw/locking cap interface contributing to breakage, and/or pseudoarthrosis
  • Discomfort or pain, soft tissue erosion, or protrusion due to prominent implanted hardware
  • Attachment device pullout, especially with osteoporotic bone
  • Implant or graft extrusion through the skin
  • Postural deformities, pain, skin breakdown, or residual neural compression due to kyphosis or lordosis occurring at the top of the segment being instrumented
  • Bone loss or fracture due to stress shielding
  • Foreign body reaction to the device including tumor formation, autoimmune disease, metallosis, and/or scarring
  • Non-union or pseudoarthrosis
  • Cessation of growth at the fusion site
  • Discitis, arachnoiditis, and/or other types of inflammation

Possible general or local postoperative complications/adverse reactions that may require medical or surgical intervention (e.g., implant removal with or without re-instrumentation) include:

  • Hemothorax
  • Deep vein thrombosis, thrombophlebitis, and/or pulmonary embolism that may be fatal; may be due to patient position and/or length of the surgical procedure
  • Decubitus ulcer
  • Wound infection, deep or superficial, which may require implant removal and/or other medical interventions
  • Wound dehiscence, delayed wound healing, or hematoma
  • Pain, possibly severe in nature
  • Urinary tract infection
  • Blood vessel damage and/or blood loss or hemorrhage
  • Fracture(s) of the bone
  • Gastrointestinal, urological, and/or reproductive system compromise including sterility, impotency, and/or loss of consortium
  • Bone graft donor site pain
  • Inability to resume activities of normal daily living