The Vital Spinal Fixation System is a subsystem of the Vitality
Spinal Fixation System
Important Information for the Vitality Spinal Fixation System
Before using a product placed on the market by Zimmer Biomet, the
operating surgeon should study carefully the following
recommendations, warnings and instructions, as well as the available
product-specific information (e.g., product literature, written
surgical technique). Zimmer Biomet is not liable for complications
that may arise from the use of the device in circumstances outside of
Zimmer Biomet’s control including, but not limited to, product
selection and deviations from the device’s intended uses or surgical technique.
Compatibility between all Zimmer Biomet Spine product lines,
including acquisitions of pre-existing product lines, has not been
established. Only authorized combinations of products should be used.
Only use as indicated in the Instructions for Use (Package Insert)
and/or the Surgical Technique.
The Vitality Spinal Fixation System is a thoracolumbar and
sacroiliac fixation system designed to aid in the surgical correction
of several types of spinal conditions. The system consists of a
variety of spinal rods, pedicle screws, hooks and connectors intended
only to provide temporary stabilization during the development of a
solid fusion of the spine with bone graft. The system can be rigidly
locked into a variety of configurations, with each construct being
customized to the patient’s anatomy. All implants are single use only
and should not be reused under any circumstances. The implant system
is intended to be removed after solid fusion has occurred.
The system also includes instrumentation for insertion, securing and
removal of the implants. All implants are made from medical grade
titanium alloy; select rods are also available in medical grade cobalt
chromium alloy. Implants made from medical grade titanium, medical
grade titanium alloy, and medical grade cobalt chromium may be used
together. Never use titanium, titanium alloy, and/or cobalt chromium
with stainless steel in the same implant construct. The Vitality
Spinal Fixation System is compatible with components from other
cleared spinal fixation systems. See Indications below.
Refer to the Vitality Spinal Fixation System Surgical Technique
Guide for additional information on how to use this device. Contact
your Zimmer Biomet Spine Sales Representative or Zimmer Biomet
Customer Service for a copy of the current Surgical Technique.
The Vitality Spinal Fixation System implants are non-cervical spinal
fixation devices intended for posterior pedicle screw fixation
(T1‑S2/ilium), posterior hook fixation (T1‑L5), or anterolateral
fixation (T8‑L5). Pedicle screw fixation is indicated for skeletally
mature patients and for adolescent patients.
These devices are indicated as an adjunct to fusion for all of the
following indications: degenerative disc disease (defined as
discogenic back pain with degeneration of the disc confirmed by
history and radiographic studies), spondylolisthesis, trauma (i.e.,
fracture or dislocation), deformities or curvatures (i.e. scoliosis,
kyphosis, and/or lordosis, Scheuermann’s Disease), tumor, stenosis,
pseudoarthrosis and/or failed previous fusion. When used as an adjunct
to fusion, the Vitality Spinal Fixation System is intended to be used
with autograft and/or allograft.
In addition the Vitality Spinal Fixation System is intended for
treatment of severe spondylolisthesis (Grade 3 and 4) of the L5‑S1
vertebra in skeletally mature patients receiving fusion by autogenous
bone graft, having implants attached to the lumbosacral spine and or
ilium with removal of the implant after attainment of a solid fusion.
Levels of pedicle screw fixation for these patients are L3-sacrum/ilium.
When used for posterior non-cervical pedicle screw fixation in
pediatric patients, the Vitality System implants are indicated as an
adjunct to fusion to treat adolescent idiopathic scoliosis. The
Vitality System is intended to be used with autograft and/or
allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
The use of the Vitality Spinal Fixation System in skeletally mature
patients may include the fixation of the Instinct® Java™
Spinal Fixation System* hooks, APEX Spinal
System™* hooks, or fixation of the Universal
Clamp® Spinal Fixation System* to the rods of
the Vitality Spinal Fixation System. The Vitality Spinal Fixation
System may also be used in skeletally immature patients when connected
with the Universal Clamp Spinal Fixation System.
In order to achieve additional levels of fixation in skeletally
mature patients, the Vitality Spinal Fixation System may be connected
to the Virage® OCT Spinal Fixation System* and
the Instinct Java Spinal Fixation System offered by Zimmer Biomet
Spine, using rod connectors.
* These optional components are not approved in all regions.
The Vitality System is not designed or sold for any use
except as indicated. DO NOT USE THE VITALITY SYSTEM IMPLANTS IN THE
PRESENCE OF ANY CONTRAINDICATION.
- Insufficient bone quantity, severe osteoporosis, or other
condition that might compromise rigid fixation of the device.
- A history of infection, active systemic infection or infection
localized to the site of the proposed implantation.
- Suspected or documented metal allergy or intolerance.
disorder affecting the normal process of bone remodelling, including
but not limited to severe osteoporosis involving the spine,
excessive bone reabsorption, osteopenia, a primary or metastatic
tumor involving the spine, or certain metabolic disorders of
- Iliac screws and offset connectors should not
be used in cases of tumor or trauma of the sacrum, when additional
screw fixation in S1 is not possible.
- Other relative
contraindications include obesity, pregnancy, certain degenerative
diseases, and foreign body sensitivity. In addition, 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.
Warnings and Precautions
Following are specific warnings, precautions, and adverse effects
associated with use of the Vitality System that should be
understood by the surgeon and explained to the patients. General
surgical risk should be explained to the patients prior to surgery.
- Implantation of the Vitality System should be performed
only by experienced spinal surgeons.
- All implants are
intended for single use only. Single use devices should not be
re-used. Possible risks associated with re-use of single-use devices
- Mechanical malfunction
- Transmission of
- Metal sensitivity has
been reported following exposure to orthopedic implants. The most
common metallic sensitivities (nickel, cobalt, and chromium) are
present in medical grade stainless steel and cobalt-chrome
- Universal precautions should be observed by all end
users that work with contaminated or potentially contaminated
medical devices. Caution should be exercised when handling devices
with sharp points or cutting edges to prevent injuries during and
after surgical procedures and reprocessing.
Warning: The safety and effectiveness of pedicle screw spinal
systems have been established only for spinal conditions with
significant mechanical instability or deformity requiring fusion
with instrumentation. These conditions are significant mechanical
instability or deformity of the thoracic, lumbar, and sacral spine
secondary to severe spondylolisthesis (grades 3 and 4) of the L5‑S1
vertebra, degenerative spondylolisthesis with objective evidence of
neurological impairment, fracture, dislocation, scoliosis, kyphosis,
spinal tumor, and failed previous fusion (pseudoarthrosis). The
safety and effectiveness of these devices for any other conditions
Warning: The safety and effectiveness of this device has not
been established for use as part of a growing rod construct. The
device is only intended to be used when definitive fusion is being
performed at all instrumented levels.
Additional Warnings for Pediatric Patients:
The use of
pedicle screw fixation in the pediatric population may present
additional risks when patients are of smaller stature and skeletally
immature. Pediatric patients may have smaller spinal structures
(pedicle diameter or length) that may preclude the use of pedicle
screws or increase the risk of pedicle screw malpositioning and
neurological or vascular injury. Patients who are not skeletally
mature undergoing spinal fusion procedures may have reduced
longitudinal spinal growth, or may be at risk for rotational spinal
deformities (the “crankshaft phenomenon”) due to continued
differential growth of the anterior spine.
Precaution: The implantation of pedicle screw spinal systems
should be performed only by experienced spinal surgeons with
specific training in the use of this pedicle screw spinal system
because this is a technically demanding procedure presenting a risk
of serious injury to the patient.
Additional Precautions for Pediatric Patients:
implantation of pedicle screw spinal systems in pediatric patients
should be performed only by experienced spinal surgeons with
specific training in the use of this pedicle screw spinal system in
pediatric patients because this is a technically demanding procedure
presenting a risk of serious injury to the patient.
Preoperative and operating procedures, including knowledge of
surgical techniques, good reduction, and proper selection and
placement of the implants are important considerations in the
successful utilization of the system in pediatric patients.
The selection of the proper size, shape and design of the
implant for each patient is crucial to the safe use of this device
in pediatric patients.
Additional preoperative, intraoperative, and postoperative warnings
- Usage of automated cleaning processes without supplemental
manual cleaning may not result in adequate cleaning of
- Proper handling, decontamination (including
pre-rinsing, washing, rinsing and sterilization), storage and
utilization are important for the long and useful life of all
surgical instruments. Even with correct use, care and maintenance,
they should not be expected to last indefinitely. This is especially
true for cutting instruments (e.g., bone awls/drills) and driving
instruments (e.g., drivers). These items are often subjected to high
loads and/or impact forces. Under such conditions, breakage can
occur, particularly when the item is corroded, damaged, nicked or
- Never use titanium, titanium alloy, and/or cobalt
chromium with stainless steel in the same implant construct;
otherwise, galvanic corrosion may occur.
- Zimmer Biomet does
not specify the maximum number of times a re-usable instrument may
be re-used. The useful life of these instruments is highly dependent
on a number of factors including the frequency and manner in which
they are used and the handling they experience in between uses.
Inspection and, where appropriate, functional testing prior to
using, is the best way to determine whether or not an individual
device should be used.
- If contouring of the implant is necessary for optimal fit, the
contouring should be gradual and avoid any notching or scratching of
the implant surface. Do not repeatedly or excessively bend the
implant. Do not reverse bend the rods.
- Pedicle bone
integrity should be verified.
- Care should be taken during
pedicle preparation to avoid penetrating too deep.
should be taken during bone preparation to avoid damage to the
pedicle and to the surgical instruments.
- Care should be
taken to minimize soft tissue damage during surgery.
should be taken to avoid removing excess material from the
- Care should be taken to avoid cross-threading screws
and closure tops.
- If any implant or instrument comes in
contact with a non-sterile surface it should not be used.
- 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
- The Vitality System is
a temporary internal fixation device. Internal fixation devices are
designed to stabilize the operative site during the normal healing
process. After healing occurs, these devices serve no functional
purpose and should be removed. Implant removal should be followed by
adequate postoperative management to avoid fracture or
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.
- Non-union, delayed union
- Bending or fracture of
implant. Fraying, kinking, loosening, bending or breaking of any or
all implant components.
- Loosening of or migration of the
- Metal sensitivity or allergic reaction to a foreign
- Decrease in bone density due to
- Pain, discomfort, or abnormal sensations
due to the presence of the device
- Loss of the natural
curvature of the spine
- Modification of the spinal geometric
corrections of the vertebral and/or intervertebral height and/or of
the reduction in spinal deformities
- Vascular and/or nerve
damage due to surgical trauma or presence of the device.
- Neurological difficulties including bowel and/or bladder
dysfunction, impotence, retrograde ejaculation and
- Dural leak
- Erosion of blood vessels due to
the proximity of the device, leading to hemorrhage and/or death
- Additional surgery may be required to correct any of these
potential adverse effects
- Additional Potential Adverse
Effects for Pediatric Patients:
- Inability to use pedicle
screw fixation due to anatomic limitations (pedicle dimensions,
- Pedicle screw malpositioning, with
or without neurological or vascular injury
- Proximal or
distal junctional kyphosis
Other adverse events related to pedicle screw fixation, such as
screw or rod bending, breakage, or loosening, may also occur in
pediatric patients, and pediatric patients may be at increased risk
for device-related injury because of their smaller stature.