Endoskeleton® TCS
CONTROLLED
Interbody Fusion Device
6140 W.ExecutiveDrive, Suite A
Mequon,WI 53092 USA
TEL:(262)2427801
www.titanspine.com
Notice:oneormoreproducts
arecoveredby patents
Symbol Legend
For use by or on the order of a physician Lot number
Manufactured by: Titan Spine® Catalog number
Caution Non-sterile: Sterilize before use
Manufacturing date Sterilized using irradiation
Expiration date Consult instructions for use
Do not re-use
P/N5303-0002
Rev02
Endoskeleton® TCS lnterbody Fusion Device
English
ENDOSKELETON® is a registered trademark ofTitan Spine®
Instructions for Use / Surgical Technique
CAUTION: Federal (USA) law restricts these devices to sale by or on the order of a licensed physician.
DESCRIPTION: The ENDOSKELETON®TCS Interbody Fusion Device is available in a variety of sizes and is designed with a large hollow region in the center to house bone graft material.The design
incorporates“windows” through the implant to permit visualization of the graft material and over time formation of new bone. The superior and inferior surfaces include either the Chemtex® surface
treatment or nanoLOCK® surface treatment (MMN™) to improve xation to the adjacent bone.The nanoLOCK® surface technology (MMN™) provides a microscopic roughened surface with nano-scale
features.The new bone formation through the implant is intended to provide long-term structural support and fusion at the implanted disc space.The ENDOSKELETON® TCS Interbody Fusion Device
system includes integrated xation screws for stabilizing the implants when placed in the interbody space.The implants and associated device components are composed of ASTM F136Ti6Al4V ELI
titanium alloy and are provided either sterile or non-sterile.
An implant holding feature has been incorporated into the trailing surface of the implant to mate with the implant inserter, and to facilitate placement of the implant into the interbody space. Screws
include internal hexalobular drive features matched to instrumentation for installation.
The ENDOSKELETON®TCS Plate Device (Plate) is only compatible with the ENDOSKELETON®TCS Interbody Fusion Device product family.The design incorporates a locking screw to secure the Plate
to the Interbody Fusion Device and is engaged after the plate is placed on the anterior face of the ENDOSKELETON®TCS Interbody Fusion Device to resist the integrated screws from backing out.The
system includes a holding feature on the Plate to mate with the inserter to facilitate placement onto the ENDOSKELETON®TCS Interbody Fusion Device implant. These plates are optional and do not
qualify as supplemental xation.
INDICATIONS FOR USE:The ENDOSKELETON® TCS Interbody Fusion Device is an anterior cervical intervertebral body fusion device indicated for use in skeletally mature patients with degenerative disc
disease (DDD) (dened as pain of discogenic origin with degeneration of the disc conrmed by history and radiographic studies) at one disc level from C2 toT1. Patients should have received 6 weeks
of non-operative treatment prior to treatment with the device.The device is indicated to be used with autograft bone or allograft bone comprised of cancellous and/or corticocancellous bone.The
device is a stand-alone system when used with ENDOSKELETON®TCS Interbody Fusion Device integrated screws and when used without the integrated screws it requires additional supplemental
xation cleared by the FDA for the cervical spine.
WARNINGS: In using metallic implants, the surgeon should be aware of the following:
1. 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.
2. The surgeon must ensure that all necessary implants and instruments are on hand prior to surgery. An adequate inventory of implant sizes should be available at the time of surgery, including sizes
larger and smaller than those expected to be used.
3. The correct handling of the implants is extremely important. Contouring of the implants is to be avoided.
4. The Titan Spine ENDOSKELETON®TCS Interbody Fusion Device and associated device components has not been evaluated for safety and compatibility in the MR environment. It has not been tested
for heating, migration, or image artifact in the MR environment. Scanning a patient who has this device may result in patient injury.
CONTRAINDICATIONS:
1. As with all orthopedic implants, the ENDOSKELETON® TCS Interbody Fusion Device should never be reused under any circumstances. Reuse may result in but is not limited to the following; infection
or bending, loosening or breakage due to impairment of implant integrity.
2. The ENDOSKELETON®TCS Interbody Fusion Device should never be implanted in patients with a systemic or local infection.
3. The ENDOSKELETON®TCS Interbody Fusion Device should not be used with components of any other interbody systems.
4. The ENDOSKELETON®TCS Interbody Fusion Device should not be implanted in patients with an allergy to titanium or titanium alloys.
5. All patients should have at least 6 weeks of non-operative care prior to spinal fusion with the ENDOSKELETON®TCS Interbody Fusion Device.
6. The ENDOSKELETON®TCS Interbody Fusion Device should not be implanted in patients with a prior fusion at the level(s) to be treated.
PRECAUTIONS:
Preoperative:
1. Only patients that meet the criteria described in the indications should be selected.
2. Based on fatigue testing results, when using the ENDOSKELETON®TCS Interbody Fusion Device, the physician/surgeon should consider the levels of implantation, patient weight, patient activity level,
other patient conditions, etc., which may impact on the performance of this system.
3. Safety and eectiveness has notbeen established in patients with the following conditions: morbidobesit y; symptomatic cardiac disease; pregnancy; signsof local inammation; fever orleukocytosis;
metal sensitivity/allergy to the implant materials; any medical or surgical condition which would preclude the potential benet of spinal implant surgery, such as the elevation of sedimentation rate
unexplained by other diseases, elevation of white blood count (WBC ), or a marked left shift in the WBC dierential count; grossly distorted anatomy due to congenital abnormalities; osteopenia,
and/or osteoporosis (osteoporosis is a relative contraindication since this condition may limit the obtainable correction, the amount of mechanical xation, and /or the quality of the bone graft);
long term systemic corticosteroid use; active drug abuse; any case requiring the mixing of metals from dierent components; any patient having inadequate tissue coverage over the operative site or
where there is inadequate bone stock, bone quality, or anatomical denition; any patient unwilling to cooperate with the postoperative instructions; any time implant utilization would interfere with
anatomical structures or expected physiological performance. Patient conditions and/or predispositions such as these should be avoided. Other conditions may exist where safety and eectiveness
have not been established.
4. Care should be used in handling and storage of the implants and instruments.The implants should not be scratched or otherwise damaged. Implants and instruments should be protected during
storage especially from corrosive environments. D evices should be routinely i nspected; if they exhibit wear, damage, corrosion, or discoloration they should be returned to Titan Spine for further
evaluation.
5. The type of construct to be assembled for the case should be determined prior to beginning the surgery.
6. Because mechanical parts are involved, the surgeon should be familiar with the various components before using the equipment and should personally assemble the implants to verify that all parts
and necessary instruments are present before the surgery begins.
7. Proper implant selection and patient compliance to postoperative precautions will greatly aect surgical outcomes. Patients who smoke have been shown to have an increased incidence of nonunion.
Therefore, these patients should be advised of this fact and warned of the potential consequences.
8. Postoperative care is important.The patient should be instructed in the limitations of his/her metallic implant(s) and should be cautioned regarding weight bearing and body stress on the appliance
prior to secure bone healing.
Intraoperative:
1. Any instruction manuals should be carefully followed.
2. At all times, extreme caution should be used around the spinal cord and nerve roots. Damage to nerves may occur resulting in loss of neurological functions.
3. The implant surfaces should not be scratched or notched since such actions may reduce the functional strength of the construct.
4. Autograft bone or allograft bone comprised of cancellous and/ or corticocancellous bone must be placed in the area to be fused and the graft must be in contact with viable bone.
5. Internal and external threads on instruments can be damaged by cross-threading. Inspect internal and external threads for damage prior to assembly. If threads are damaged, set the product aside
and do not use. When threading components together, keep to the thread axis. Screw in the component as far as it will go and make sure that the product is ush with the insertion instrument. On
all threaded connections, nger tighten only.
Postoperative:
1. The physician’s postoperative directions and warnings to the patient and corresponding patient compliance are extremely important.
2. Detailed instructions on the use and limitations of the implant(s) should be given to the patient. If par tial weightbearing is recommended or required prior to rm bony union, the patient must be
warned that bending, loosening or breakage of the implant(s) are complications which can occur as a result of excessive or early weight bearing or excessive muscular activity. The risk of bending,
loosening or breakage of an internal xation device during postoperative rehabilitation may be increased if the patient is active or if the patient is debilitated, demented or otherwise unable to use
crutches or other such weight supporting devices.The patient should be warned to avoid falls or sudden jolts in spinal position.
3. To allow maximum chances for a successful surgical result, the patient or implant(s) should not be exposed to mechanical vibrations that may loosen the implant(s).The patient should be warned of
this possibility and instructed to limit and restrict physical activities, especially lifting, twisting motions and any type of sport participation.The patient should be advised not to smoke or consume
alcohol during the bone graft healing process.
4. The patient should be advised of their inability to bend at the point of spinal fusion and taught to compensate for this permanent physical restriction on body motion.
5. If a nonunion develops or if the implant(s) loosen, bend and /or break, the implant(s) should be revised and/or removed immediately beforeserious injur y occurs. Failureto immobilize a delayed or
nonunion of bone will result in excessive and repeated stresses on the implant(s). By the mechanism of fatigue these stresses can cause eventual bending, loosening or breakage of the implant(s).
It is important that immobilization of the spinal surgical site be maintained until rm bony union is established and conrmed by roentgenographic examination. The patient must be adequately
warned of these hazards and closely supervised to ensure cooperation until bony union is conrmed.
6. Any retrieved implants should be treated in such a manner that reuse in another surgical procedure is not possible. As with all orthopedic implants, none of the ENDOSKELETON®TCS Interbody Fusion
Devices should ever be reused under any circumstances. Reuse may result in but is not limited to the following; infection or bending, loosening or breakage due to impairment of implant integrity.
ADVERSE EVENTS: Possible adverse eects include, but are not limited to, bending, loosening, or fracture of the implants or instruments; loss of xation; sensitivity to a metallic foreign body, including
possible tumor formation; skin or muscle sensitivity in patients with inadequate tissue coverage over the operative site, which may result in skin breakdown and/or wound complications; nonunion
or delayed union; infection; nerve or vascular damage due to surgical trauma, including loss of neurological function, dural tears, radiculopathy, paralysis, and cerebral uid leakage; gastrointestinal,
urological and/or reproductive system compromise, including sterility, impotency, and/or loss of consortium; pain or discomfort; bone loss due to resorption or stress shielding, or bone fracture at,
above, or below the level of surgery (fracture of the vertebra); hemorrhage of blood vessels and/or hematomas; malalignment of anatomical structures, including loss of proper spine curvature,
correction, reduction, and/or height; bursitis; bone graft donor site pain; inability to resume activities of normal daily living; reoperation or death.
CLEANING & STERILIZATION: Refer to Reprocessing Instructions forTitan Spine Devices 70-0015 for detailed instruction. ENDOSKELETON® TCS Interbody Fusion Device implants and associated device
components are provided either sterile or non-sterile, see package labeling for identication. Implants and associated device components provided sterile are sterilized with gamma irradiation.
Implants or associated device components removed from sterile packaging but never used in surgery, as well as implants or associated device components found in damaged packaging must be
returned toTitan Spine for proper disposition. ENDOSKELETON® TCS Interbody Fusion Device non-sterile implants, associated device components and instrumentation are provided nonsterile in a
reusable rigid Aesculap® SterilContainer™ System or surgical case and must be sterilized prior to use.The rigid Aesculap® SterilContainer™ System has been validated for use with the single use paper
lter (US751) only. It is recommended that surgical cases that are provided without rigid Aesculap® SterilContainer™ Systems are sterilized with FDA-cleared sterilization wraps. Disassemble all
instruments, specically the retractable awl (5210-1022) and the xed angled driver (5210-1067).To disassemble the awl, unthread the outer sleeve, remove the sleeve halves from the inner shaft.
For the driver, unthread the inner shaft from the outer body by turning the knob counterclockwise.Then, remove the driver/drill tip from the outer body by sliding the outer sheath away from the tip
of the driver.
defects or aws in any of the components.
AP and lateral x-rays must be reviewed by the implanting surgeon to verify that the patient’s vertebral body dimensions are of sucient size to accommodate one of the ENDOSKELETON®TCS
Interbody Fusion Device implant sizes.
Patient Positioning:The patient is brought to the operating room, transferred to the surgical table in the supine position and put to sleep under general anesthesia. An endotracheal tube is placed to
facilitate breathing during surgery.The surgical area is then cleaned, and sterilely prepped and draped.
Surgical Approach: The surgeon begins the procedure through an anterior transverse incision. Access to the appropriate disc space is performed in the surgeon’s usual manner.
A pin is placed in the disc space and uoroscopy is taken to conrm access of the correct level and to conrm the position of the midline.
Optional Placement of Plate
Pinch the tips of the Plate Holder (Figure 1a) until the tips can be inserted into the holes of the Plate (Figure 1b). Insert one tip rst, and then the second. Connect the Locking Plate Driver shaft with
the torque limiting handle by pulling back on the collar of the handle, inserting the square drive of the shaft into the collet, and releasing the collar (Figure 2). The Locking Plate Driver shaft is then
inserted onto the handle end of the Plate Holder until the tip of the driver engages the screw head of the Plate. You should feel a click as ball detents in the Plate Holder engage the groove in the
driver shaft. Deliver the construct, plate rst, into the exposure, and place the tip of the screw into the threaded hole in the anterior of the ENDOSKELETON®TCS Interbody Fusion Device. Orient the
plate by rotating the Plate Holder until the plate is positioned over both bone screw heads (Figure 3). The ats (Figure 4) on the handle of the Plate Holder should be oriented cephalad/caudal. While
maintaining this orientation, secure the Plate by driving the screw clockwise until the torque handle clicks. Once the Plate is fully seated, the Plate Holder is disengaged by holding the torque handle
steady and pulling up on the Plate Holder (Figure 5). An example of a construct with the optional Plate is provided in Figure 6.
Note:The ENDOSKELETON® TCS Plate Devices resist integrated screws from backing out. These plates do not qualify as supplemental xation and may only be used with ENDOSKELETON® TCS Interbody
Fusion Devices.
Figure 2
Figure 1b
Figure 3
Figure 1a
Figure 4
Figure 5
Figure 6
Removal and Revision
Removal or revision of the Plate during the index procedure may be deemed necessary by the surgeon. If one or more of the IBD, Screw(s), or Plate need to be repositioned or removed during the
index procedure, the Plate must rst be removed.The Plate Holder is to be re-engaged onto the Plate (Figure 4).The Locking Plate Driver Shaft is to be used to turn the locking screw counterclockwise
to disengage from the IBD (Figure 3).The Plate may then be removed from the IBD and any adjustments made to the construct. If removal or revision of the construct through the original access
approach is required at a time after the index procedure, the surgeon may utilize the instrumentation described above.
PRODUCT CONFIGURATIONS:The ENDOSKELETON® TCS Interbody Fusion Device implants are provided in a wide range of sizes to allow the surgeon a variety of options when determining the appropriate
size for the procedure.
5210-1022
Thoroughly clean instrumentation, especially the long and narrow lumens, and blind holes carefully. Clean instruments as soon as possible after use and sterilize. Repeat cleaning if instrumentation
is not visually clean. Clean rigid Aesculap® SterilContainer™ systems in accordance with the manufacturer’s specications.The detergent manufacturer’s instructions should be followed to achieve
the correct dilution, temperature, contact time, and water quality. Hospital approved methods should be followed when handling implants or instruments contaminated with blood, tissue, and /or
bodily uid.The ENDOSKELETON® TCS System must be sterilized in a properly functioning, calibrated steam sterilizer. Refer to Reprocessing Instructions forTitan Spine Devices 70-0015 for detailed
instructions.
A copy of the Reprocessing Instructions for Titan Spine Devices 70-0015 document can be obtained by contacting Titan Spine at 262-242-7801 or tsinfo@titanspine.com.
The following sterilization cycle should be used (in accordance with ANSI/AAMI ST79 or ISO 14937 and ISO 17665-1):
The following sterilization cycles (in accordance with ANSI/AAMI ST79 or ISO 14937 and ISO 17665-1) are recommended for use with the FDA-cleared sterilization wraps:
A copy of the IFU/Surgical Technique Guide and the Reprocessing Instructions forTitan S pine Devices 70-0015 document can be obtained by contacting Titan Spine at 262-242-7801
or tsinfo@titanspine.com.
SURGICAL TECHNIQUE STEPS DIRECTIONS FOR USE: The ENDOSKELETON®TCS Interbody Fusion Device and associated device components should only be implanted by surgeons who are experienced in
the use of such implants and the required specialized spinal surgery techniques. Refer to the ENDOSKELETON®TCS Plate SurgicalTechnique in the following section. For more detailed instructions for
the ENDOSKELETON®TCS Interbody Fusion Device refer to IFU 5346-0002 which is available by contactingTitan Spine at 262-242-7801 or tsinfo@titanspine.com.
Preoperative Planning: Prior to surgery the operating room sta must inspect the surgical trays and implants to be sure there is an adequate supply of each of the implant sizes and each of the
instruments.The surgical trays containing the non-sterile implants, trial spacers, and instruments must be cleaned and sterilized prior to use. All components must be inspected to verify there are no
5210-1067
Surgical Case Method Cycle Temperature Exposure Time Dry Time
Rigid Sterilization Container* Steam* Pre-vacuum* 273°F (134°C)* 3 minutes* Minimum 30 minutes*
Surgical Case Method Cycle Temperature Exposure Time Dry Time
Wrapped Steam Pre-vacuum 270°F (132°C) 4 minutes Minimum 30 minutes
Wrapped* Steam* Pre-vacuum* 273°F (134°C)* 3 minutes* Minimum 30 minutes*
Wrapped* Steam* Pre-vacuum* 275°F (135°C)* 3 minutes* Minimum 30 minutes*
*This pre-vacuum sterilization cycle, 273°F, 3-minute exposure, 30-minute dry time cycle, and this pre-vacuum sterilization cycle,
275°F, 3-minute exposure, 30-minute dr y time c ycle are not considered by the Food and Drug Administration to be a standard
sterilization cycle. It is the end user’s responsibility to use only sterilizers and accessories (such as sterilization wraps, sterilization
pouches, chemical indicators, biological indicators, and sterilization cassettes) that have been cleared by the Food and Drug
Administration for the selected sterilization cycle specications (time and temperature).
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