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The Tether™ – Vertebral Body Tethering System Is a Non-Fusion the Tether Spinal Device Intended for Treatment of Idiopathic Scoliosis

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The Tether™ – Vertebral Body Tethering System Is a Non-Fusion the Tether Spinal Device Intended for Treatment of Idiopathic Scoliosis INSTRUCTIONS FOR USE en DEVICE DESCRIPTION ™ The Tether™ – Vertebral Body Tethering System is a non-fusion The Tether spinal device intended for treatment of idiopathic scoliosis. Vertebral Body Tethering System Anchors and vertebral body screws are placed laterally from a thoracoscopic or thoracotomy approach into the vertebral body on the convex side of a spinal deformity. A SULENE® polyethylene terephthalate (PET) tensioning cord is secured to the vertebral Zimmer Biomet Spine, Inc. only 10225 Westmoor Dr. body screws with set screws to connect the levels of the construct. Westminster, CO 80021 USA The device provides a lateral tension band across the convex +1 800.447.3625 zimmerbiomet.com side of the spine that, on insertion and tensioning, partially corrects the curvature, and subsequently can arrest or correct the deformity through modulation of remaining spinal growth. In addition, the subject system includes instrumentation for insertion, Humanitarian Device. Authorized by Federal law for use in manipulation, and removal of the implants. the treatment of skeletally immature patients that require MATERIALS surgical treatment to obtain and maintain correction of The Tether™ - Vertebral Body Tethering System is manufactured progressive idiopathic scoliosis, with a major Cobb angle of from: • Anchors: Ti 6Al-4V ELI titanium alloy per ASTM F136 30 to 65 degrees whose osseous structure is dimensionally • Set Screws: Ti 6Al-4V ELI titanium alloy per ASTM F136 adequate to accommodate screw fixation, as determined by • Bone Screws: Ti 6Al-7Nb titanium alloy per ISO 5832-11 radiographic imaging. Patients should have failed bracing with an hydroxyapatite coating per ISO 13779-2 and/or be intolerant to brace wear. The effectiveness of this • Cord: Sulene® PET (polyethylene-terephthalate) device for this use has not been demonstrated. • Instruments and Cases: Generally comprised of aluminum, stainless steel, titanium alloy, and/or polymeric materials INDICATIONS FOR USE Commonly Used Symbols for Medical Devices The Tether™ - Vertebral Body Tethering System is indicated for Note: Refer to the individual package label for symbols applicable to the product. skeletally immature patients that require surgical treatment to SYMBOL DEFINITION obtain and maintain correction of progressive idiopathic scoliosis, with a major Cobb angle of 30 to 65 degrees whose osseous Manufacturer structure is dimensionally adequate to accommodate screw fixation, as determined by radiographic imaging. Patients should Date of manufacture have failed bracing and/or be intolerant to brace wear. Use by date CONTRAINDICATIONS The Tether™ - Vertebral Body Tethering System should not be 2 Do not re-use implanted in patients with the following conditions: 2 Sterilize Do not re-sterilize 1. Presence of any systemic infection, local infection, or skin compromise at the surgical site; Do not use if package is damaged 2. Prior spinal surgery at the level(s) to be treated; Diameter 3. Known poor bone quality defined as aT-score -1.5 or less; Consult instructions for use 4. Skeletal maturity; 5. Any other medical or surgical condition which would preclude Caution: Consult accompanying documents the potential benefit of spinal surgery, such as coagulation disorders, allergies to the implant materials, and patients MR conditional unwillingness or inability to cooperate with post-operative care instructions. NON STERILE Non-sterile O Sterilized using ethylene oxide PREOPERATIVE PROCEDURE The surgeon is responsible for being familiar with the indications, Sterilized using irradiation contraindications, system/procedure risks, and surgical technique to ensure proper treatment, patient selection, and postoperative Quantity per package care when using The Tether™ - Vertebral Body Tethering System. The patient must be an acceptable surgical risk, and appropriate Batch code for vertebral body tethering based on consideration of various factors such as preoperative Cobb angle, curve flexibility, curve Reference type(s), curve location(s), skeletal maturity, and anticipated growth, among others. Examination and evaluation of the Authorized representative in the European Community individual patient anatomy is necessary to plan the appropriate Caution: Federal (USA) law restricts this device to sale by or surgical procedure and technique. Due to smaller vertebral body on the order of a physician size and variable venous anatomy, caution should be observed if extending instrumentation proximal to T5. IFU0021-0117-en Rev 02 2019-06 1 Zimmer Biomet Spine does not specify the maximum number of 5. The Tether™ - Vertebral Body Tethering System must not times a re-usable instrument may be re-used. The useful life of be used with vertebral components or instruments from these instruments is highly dependent on a number of factors other manufacturers. Specialized instruments are designed including the frequency and manner in which they are used and for Zimmer Biomet Spine implant systems to aid in proper the handling they experience in between uses. Inspection and, implantation. The use of instruments or implant components where appropriate, functional testing prior to instrument use is the from other systems can result in inaccurate fit, incorrect sizing, best way to determine whether or not an individual device should excessive wear and device failure. be used. Review and inspect all instrumentation and implants prior 6. Surgical instruments are subject to wear with normal usage. to use. Replace or add any needed components for the planned Instruments with cutting functions or points may become surgery. dull with normal use and no longer perform as intended. Use of automated cleaning processes without supplemental Instruments that have experienced extensive use are manual cleaning may not result in adequate cleaning of instruments. susceptible to fracture. Proper handling, decontamination (including pre-rinsing, washing, 7. Do not modify instruments. Do not notch, bend, or reshape rinsing and sterilization), storage and utilization are important for instruments. Notches, scratches or other damage and/ the long and useful life of all surgical instruments. Even with correct or wear in the instrument occurring during surgery may use, care and maintenance, instruments should not be expected to contribute to breakage. Do not use an instrument that has last indefinitely. This is especially true for cutting instruments (e.g., become bent from its original shape as this will affect the bone awls/drills) and driving instruments (e.g., drivers). These performance of the instrument. Bent instruments should be items are often subjected to high loads and/or impact forces. Under disposed of by a Zimmer Biomet Spine representative or such conditions, breakage can occur, particularly when the item is according to hospital procedures. corroded, damaged, nicked or scratched. 8. The use of an instrument for tasks other than those for OPERATIVE PROCEDURE which they are indicated may result in damaged or broken For surgical placement of The Tether™ - Vertebral Body Tethering instruments. System, patients are positioned in the lateral decubitus position 9. Proper handling of the instruments and implants before and with the convex side of the curve to be instrumented facing during the operation is crucial. Do not apply excessive force; upwards. As most idiopathic thoracic curves are convex towards misuse can damage instruments or implants. the right side, a left lateral decubitus position will be the most common position utilized for instrumentation of thoracic curves. PRECAUTIONS For recommended surgical site preparation, positioning, and 1. Due to smaller vertebral body size and variable vascular technique details, please see the Surgical Technique Guide. anatomy, caution should be observed if extending For thoracoscopic surgery, standard anesthesia protocol should instrumentation proximal to T5. be observed. However, it is recommended to use a single lung ventilation technique such as a double-lumen endotracheal tube to 2. Care should be taken when using instruments over a aid surgical exposure if necessary. Anchor use is recommended at guidewire to avoid unintentional advancement of the all levels. Consideration should be given to the osseous structure guidewire which could result in damage to vessels, spinal at each level to determine if both a bone screw and anchor are cord, or lungs. needed to adequately support the construct and anticipated loads. 3. Extreme caution must be taken to avoid damage to vessels, Please refer to the Surgical Technique Guide if implant removal spinal cord, or lungs during placement of instruments and is required (including revision). Close wound(s) and apply wound implants. dressing using standard techniques. 4. The Tether™ - Vertebral Body Tethering System is intended POSTOPERATIVE CARE to be used by surgeons specialized in spinal surgery with It is critical that patients follow all postoperative instructions thorough knowledge of vertebral anatomy, regional vertebral provided by care providers including recommendations regarding morphology, and biomechanical principles of the spine. The medications, home care, surgical wound dressings and activity surgical procedure is technically demanding and presents limitations. The patient must be warned to avoid falls or sudden a risk of serious injury to the patient. It is advised that jolts. Failure to follow postoperative instructions could lead to the surgeon also be thoroughly familiar with the surgical impaired wound healing,
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