Innovasis Excella III-D Instructions For Use Manual

__________________________________________________________________________

©2018 Innovasis Inc. Page 1 of 4 L00022 Rev G



M Innovasis, Inc.

614 East 3900 South
Salt Lake City, UT 84107 U.S.A.
Tel [phone]
Toll Free (US) [phone]
Fax [phone]

www.innovasis.com

Excella III-D® Spinal Deformity System – Instructions for Use

The Innovasis® Excella® Spinal System is intended for use in the non-cervical area of the spine.
Users of these products are limited to physicians trained in orthopedic surgery. Clinical locations include hospitals

and surgery sites equipped to perform spinal surgery.
The Excella III-D® Spinal Deformity System is designed for spinal fixation procedures in skeletally mature patients

performed through a posterior or anterolateral approach, and is intended to assist in the temporary stabilization of
spinal segments in order to provide an optimal environment for spinal fusion in the thoracolumbar region

Indications for use are as follows:

The Innovasis Excella III-D Spinal Deformity System, when used as a posterior pedicle screw system, is
intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an
adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic,
lumbar and sacral spine:

• Degenerative disc disease (DDD—defined as discogenic back pain with degeneration of the disc
confirmed by history and radiographic studies)

• Degenerative spondylolisthesis with objective evidence of neurologic impairment

• Scoliosis

• Fracture or dislocation

• Kyphosis

• Spinal tumor

• Pseudoarthrosis and failed previous fusion

The Innovasis® Excella III-D® Spinal Deformity System, is also indicated for treatment of severe spondylolisthesis
(Grades 3 & 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 implants after attainment of a
solid fusion. Levels of pedicle screw fixation for these patients are L3-sacrum/ilium.

When used as a posterior non-pedicle screw fixation system, the Innovasis Excella III-D Spinal Deformity System
is intended for the treatment of:

• Degenerative disc disease (DDD—defined as discogenic back pain with degeneration of the disc
confirmed by history and radiographic studies)

• Spinal stenosis

• Spondylolisthesis

• Spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis, Scheuermann’s disease)

• Fracture

• Pseudoarthrosis

• Tumor resection

• Failed previous fusion.

Overall levels of fixation are T1-sacrum/ilium.

__________________________________________________________________________

©2018 Innovasis Inc. Page 2 of 4 L00022 Rev G

When used as an anterolateral thoracolumbar system, the Innovasis Excella III-D Spinal Deformity System is
intended for anterolateral screw fixation for the following indications:

• Degenerative disc disease (DDD—defined as discogenic back pain with degeneration of the disc
confirmed by history and radiographic studies)

• Spinal stenosis

• Spondylolisthesis

• Spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis)

• Fracture or dislocation of the thoracolumbar spine

• Pseudoarthrosis

• Tumor resection

• Failed previous fusion.

Levels of screw fixation are T8-L5.

Contraindications for use are as follows:

i) Morbid obesity; iv) Pregnancy; vii) Active infection near the surgical site; and
ii) Mental illness; v) Metal sensitivity/allergies; viii) Patients unwilling or unable to follow post­iii) Alcoholism or drug abuse; vi) Severe osteopenia; operative care instructions.

WARNING: The safety and effectiveness of pedicle screw 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 are unknown.

PHYSICIAN NOTE: Although the physician is the learned intermediary between the company and the patient, the

important medical information given in this document should be conveyed to the patient.
IMPLANT SELECTION: The selection of the proper size of the implant for each patient is crucial to the success of

the procedure.
COMPLICATIONS: Possible adverse effects include, but are not limited to:

i) Bending or breaking of the instruments or implants ix) Bone graft donor site pain
ii) Nerve or vascular damage due to surgical trauma x) Loss of fixation
iii) Mal-alignment of anatomical structures xi) Infection
iv) Hemorrhage of the blood vessels and/or hematomas xii) Bursitis
v) Gastrointestinal, urological and/or reproductive system xiii) Non-union or delayed union

compromise (including sterility, impotency and/or loss of xiv) Bone loss due to resorption or stress

consortium) shielding, or adjacent level disc deterioration
vi) Skin or muscle sensitivity in patients with inadequate xv) Inability to resume normal daily living

tissue coverage activities
vii) Pain or discomfort xvi) Re-operation
viii) Sensitivity to a metal foreign body (including xvii) Death

possible tumor formation)

PRECAUTIONS:
GENERAL: 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. The physician/surgeon should thoroughly review the
Excella III-D Surgical Technique Guide before surgery. A copy of this guide is available at www.innovasis.com or by
request via telephone, fax or e-mail. Contact information appears at the heading of this document.

Explanted surgical implants must never be reused. This product is single use only. Even though a device appears
undamaged, it may have defects and internal stress patterns which may lead to premature failure. Mixing of different
metal types can accelerate the corrosion process. Stainless and titanium implants must not be used together in
creating a construct. Components from other manufacturers should never be used with the Excella III-D Spinal
Deformity System. Spinal components should never be reused for any reason.

The Excella III-D implants are manufactured from implant grade materials that are nonferromagnetic. The Excella III-D

Spinal Deformity System has not been evaluated for safety and compatibility in the MR environment. The Excella III-D
Spinal Deformity System has not been tested for heating, migration or image artifact in the MR environment. The safety

of the Excella III-D Spinal Deformity System in the MR environment is unknown. Scanning a patient who has this device
may result in patient injury.

__________________________________________________________________________

©2018 Innovasis Inc. Page 3 of 4 L00022 Rev G

PREOPERATIVE: The implant components should be handled and stored carefully and protected from damage.
The instruments and implants must be cleaned and sterilized before use. The surgeon must confirm that all
necessary implants and instruments are on hand for the planned surgical construct. They should be examined for
damage prior to use.

INTRAOPERATIVE: Extreme caution must be taken around the spinal cord and nerve roots, especially when
inserting screws and cross connectors. Breakage, slippage or mishandling of the instruments or implant
components, such as sharp edges, may cause injury to the patient or operative personnel. The Implants must be
handled and contoured carefully so as to avoid notching or scratching the surface. Prior to closing the soft tissues, all
caps and screws should be tightened firmly according to the surgical technique guide. Recheck the tightness of all
caps and screws after finishing ensuring that none have loosened during the tightening or manipulation of other
components.

POSTOPERATIVE: The patient must be adequately instructed as to the risks and limitations of the implant as well
as postoperative care and rehabilitation. The patient should be instructed in the limitations of physical activities,
which would place excessive stresses on the implant or cause delay in the healing process. The patient should be
instructed in the proper use of weight-bearing or assist devices as well as the proper methods of ambulation, climbing
stairs, getting into/out of bed or other daily activities while minimizing rotational and bending stresses.

The surgeon must consider the removal of the implant after healing as the implant can loosen, fracture or corrode
even after fusion has occurred. The risks and benefits of a second surgery must be carefully evaluated.

MATERIAL SPECIFICATION: Implants are manufactured out of Titanium 6AL-4V ELI which complies with ASTM
F-136 or CoCr per ASTM F-1537. INNOVASIS expressly warrants that these devices are fabricated from material
specifications. No other warranties express or implied, are made. Implied warranties of merchantability and fitness
for a particular purpose or use are specifically excluded.

Do not re-use or re-implant under any circumstances. Components of this system should not be used with
components from any other manufacturer.

CLEANING AND DECONTAMINATION: All non-sterile implants, instruments and trays must be thoroughly cleaned
using neutral cleaners before use and must be visibly clean before sterilization and subsequent introduction into a
sterile surgical field or (if applicable) return of the product to INNOVASIS. Cleaning and disinfecting of instruments
can be performed with aldehyde-free solvents at higher temperatures. Cleaning and decontamination must include
the use of neutral cleaners followed by deionized water rinse.

Note: certain cleaning solutions such as those containing formalin, gluteraldehyde, bleach and/or other
alkaline cleaners may damage some devices, particularly instruments; these solutions should NOT be used.
Also, many instruments require disassembly before cleaning.

Detailed cleaning recommendations for reusable instruments are in the Innovasis Surgical Instrument Reprocessing
Instructions LG01. A copy of this guide is available at www.innovasis.com or by request via telephone, fax or e-mail.

Contact information appears at the heading of this document.
All products should be treated with care. Improper use or handling may lead to damage and/or possible improper

functioning of the device.
STERILIZATION: The INNOVASIS® EXCELLA® SPINAL SYSTEM implants are supplied NON-STERILE. The

metal implants and instruments used in surgery MUST be sterilized by the hospital prior to use. FDA cleared wraps
are recommended for use with the sterilization tray. Remove all packaging materials prior to sterilization. Only sterile
products should be placed in the operative field. For a 10-6 Sterility Assurance Level, it is recommended that the
Excella® Spinal System implants be steam sterilized by the hospital using one of the two sets of process parameters
below:

METHOD

CYCLE

TEMPERATURE

EXPOSURE TIME

DRY TIME

Steam

Pre-vacuum (Wrapped)

2700 F (1320 C )

4 Minutes

60 Minutes*

Steam

Gravity Displacement

(Wrapped)

2700 F (1320 C )

30 Minutes

60 Minutes*

*This dry time sterilization cycle (60 minutes) is 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 specifications (time and temperature).

NOTE: Because of the many variables involved in sterilization, each medical facility should calibrate and
verify the sterilization process (e.g. temperatures, times) used for their equipment.

CAUTION: Federal Law (U.S.A.) restricts these devices to sale by or on order of a physician.

__________________________________________________________________________

©2018 Innovasis Inc. Page 4 of 4 L00022 Rev G

Symbol Glossary:

hCatalog Number gBatch Code dNon-Sterile Do not re-use Consult Instructions for Use

M Manufacturer Rx Only: Prescription only CoCr: Cobalt Chrome

Ti 6Al 4V (ELI): Titanium Alloy (Extra Low Interstitial) 316 Stainless Steel/316LVM Stainless Steel: Stainless Steel Alloy