
Emergo Europe
614 East 3900 South
Salt Lake City, UT 84107 U.S.A.
Tel +1.801.261.2236
Toll Free (US) (877) 261.2236
Fax +1.801.261.0573
www.innovasis.com
Molenstraat 15
2513 BH The Hague
The Netherlands
Tel: +(31) (0) 70 345.8570
Fax: +(31) (0) 70 346.7299

0459
Box™ PEEK IBF System – Package Insert
Description:
The Innovasis Box™ PEEK IBF (Intervertebral Body Fusion) System consists of polyetheretherketone (PEEK) implants meant to be used
with supplemental fixation. The devices are offered in a variety of different sizes and shapes, in order to better accommodate a patient’s
anatomy. The implants also feature holes in the interior geometry in order to accommodate bone graft and maximize bone in-growth.
Tantalum (A-Box) or Titanium (L-Box) markers are incorporated into the material to allow for visualization of the implant
configuration during and after surgery. The surfaces of the implants have machined barbs meant to engage the vertebral
endplates and prevent expulsion.
Intended Use: The Innovasis Box PEEK IBF System is an intervertebral body fusion device intended to stabilize a spinal
segment to promote fusion using bone graft, in order to restrict motion and decrease pain.
Indications for use are as follows:
The Innovasis Box PEEK IBF System is an intervertebral body fusion device for use in patients with degenerative disc disease
(DDD) at one or two contiguous levels of the lumbar spine (L2-S1). DDD is defined as discogenic back pain with degeneration of
the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6)
months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the
involved level(s). These implants are used to facilitate fusion in the lumbar spine and are placed via either an anterior or
anterolateral (A-Box) or lateral (L-Box) approach.
This device is intended to be used with internal supplemental spinal fixation systems such as the Innovasis Excella® Spinal
System. The interior of the Box implants is intended to be packed with autograft.
Contra-Indications for use are as follows:
Use of this system is contraindicated when there is active systemic infection, infection localized to the site of the proposed implantation, or
when the patient has demonstrated allergy or foreign body sensitivity to any of the implant materials.
Severe osteoporosis may prevent adequate fixation and thus preclude the use of this or any other orthopaedic implant.
Conditions that may place excessive stress on the bone and implant, such as severe obesity or degenerative diseases are relative
contraindications. The decision whether to use these devices under these conditions must be made by the physician taking into account the
risks versus the benefits to the patient.
Use of these implants is relatively contraindicated in patients whose activity, mental capacity, mental illness, alcoholism, drug abuse,
occupation, or lifestyle may interfere with their ability to follow postoperative restrictions and who may place undue stresses on the implant
during bone healing and may be at a higher risk of implant failure.
WARNINGS, PRECAUTIONS AND ADVERSE EFFECTS CONCERNING SPINAL FIXATION IMPLANTS
Possible adverse effects:
 Bending or fracture of implant; loosening of the implant
 Implant material sensitivity, or allergic reaction
 Decrease in bone density due to resorption or stress shielding, or adjacent level disc deterioration
 Infection, early or late
 Pain, discomfort or abnormal sensations due to the presence of the device
 Nerve damage due to surgical trauma or presence of the device. Neurological difficulties including bowel and/or bladder dysfunction,
impotence, retrograde ejaculation, radicular pain, tethering of nerves in scar tissue, muscle weakness, and paraesthesia.
 Spinal cord impingement or damage
 Fracture of bony structures
 Reflex sympathetic dystrophy
 Vascular damage could result in catastrophic or fatal bleeding. Malpositioned implants adjacent to arteries or veins could cause
erosion of these vessels and catastrophic bleeding in the later postoperative period.
 Dural tears experienced during surgery could result in need for further surgery for dural repair, a chronic CSF leak or fistula, and
possible meningitis.
 Bursitis
 Paralysis
 Death
 There is an additional risk if there were to be long term in vivo degradation of the PEEK composite resulting in possible local or
systemic adverse reactions from any potential degradation products.
 If a pseudarthrodesis occurs coupled with the IBF system, a mechanical grinding action could possibly occur which might generate
wear debris. Most types of wear debris have shown the potential of initiating local osteolysis in articulating joints.
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 Degenerative changes or instability in segments adjacent to fused vertebral levels.
WARNINGS
1.
2.
Correct selection of the implant is EXTREMELY Important. The potential for satisfactory anterior column support is increased by
the selection of the proper size device. While proper selection can help minimize risks, the size and shape of human bones present
limitations on the size, shape and strength of implants. Internal fixation devices cannot withstand activity levels equal to those placed
on normal healthy bone. No implant can be expected to withstand indefinitely the unsupported stress of full weight bearing.
Implants can break when subjected to the increased loading associated with delayed union or nonunion. Internal fixation
appliances 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 material fatigue. The degree of 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.
PRECAUTIONS
1. Box™ Surgical Implants are for SINGLE USE ONLY. An explanted implant should never be re-implanted. Even though a device
appears undamaged, it may have defects and internal stress patterns which may lead to early breakage.
2. Correct handling of the implant is extremely important. Polymer implants are designed to support physiological loads. Excessive
torque, when applied to insertion tools, can cause splitting or fracture of the implants. When a polymer implant is impacted or
hammered into place, the broad surface of the insertion tool should be carefully seated fully against the implant. Impaction forces
applied directly to a small surface of the implant could cause fracture of the implant. Split or fractured implants should be removed and
replaced.
3. The patient must be adequately instructed. Postoperative care and the patient’s ability and willingness to follow instructions are
among the most important aspects of successful bone healing. The patient needs to be aware of the limitations of the implants. The
patient should be instructed to limit and restrict lifting and twisting motions and any type of sports participation until the bone is healed.
The patient should understand that implants are not as strong as normal healthy bone and could loosen, bend and/or break if
excessive demands are placed on it, especially in the absence of complete bone healing. Implants displaced or damaged by improper
activities may experience migration of the devices and damage to nerves or blood vessels.
4. The Box PEEK IBF System has not been evaluated for safety and compatibility in the MR environment. The Box PEEK IBF System
has not been tested for heating or migration in the MR environment
POSTOPERATIVE IMMOBILIZATION
Postoperative external immobilization (such as bracing) is recommended, at the surgeon’s discretion. Instructions to the patient to reduce
stress on the implants are an equally important part of the attempt to avoid the occurrence of clinical problems that may accompany fixation
failure.
CLEANING AND DECONTAMINATION: Unless just removed from an unopened INNOVASIS package, all instruments and implants must
be disassembled and cleaned using neutral cleaners before sterilization and 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 are in the Innovasis Surgical Instrument Cleaning, Sterilization and Reuse instruction LG01.
All products should be treated with care. Improper use or handling may lead to damage and/or possible improper functioning of the device.
STERILIZATION
Implants and instruments are supplied clean but NOT STERILE. They 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, the Box™ Peek IBF System implants and instruments (full set in tray) are
recommended to be steam sterilized by the hospital using one of the two sets of process parameters listed below.
STERILIZATION PARAMETERS FOR “A-BOX SYSTEM” (ABOX-00)
METHOD
Steam
Steam
CYCLE
TEMPERATURE
Pre-Vacuum (Wrapped)
273°F to 275°F (134°C to
135°C)
270°F to 275°F (132°C to
135°C)
Gravity Displacement (Wrapped)
EXPOSURE TIME
DRY TIME
10 Minutes
60 Minutes
30 Minutes
60 Minutes
STERILIZATION PARAMETERS FOR “L-BOX IMPLANT SET” & “L-BOX SIZER SET” (XLBX-01 AND XLBX-02)
METHOD
CYCLE
TEMPERATURE
EXPOSURE TIME
Steam
Pre-Vacuum (Wrapped)
270°F (132°C)
4 Minutes
Steam
Gravity Displacement (Wrapped)
270°F (132°C)
15 Minutes
STERILIZATION PARAMETERS FOR L-BOX 3-BLADED “LATERAL & POSTERIOR RETRACTOR SET” (XLBX-07)
METHOD
CYCLE
TEMPERATURE
EXPOSURE TIME
Pre-Vacuum
Steam
(Wrapped in two layers of 1-ply cellulose based
270°F (132°C)
4 Minutes
wrap, Bio-Shield®)
Gravity Displacement
Steam
(Wrapped in two layers of 1-ply cellulose based
275° F (135° C)
10 Minutes
wrap, Bio-Shield®)
DRY TIME
45 Minutes
45 Minutes
DRY TIME
30 Minutes
30 Minutes
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STERILIZATION PARAMETERS FOR “L-BOX DISC PREP SET” (XLBX-08)
METHOD
Steam
Steam
Steam
CYCLE
Pre-Vacuum (Wrapped in two layers of 1-ply
polypropylene wrap, Kimguard KC600)
Pre-Vacuum (Wrapped in two layers of 1-ply
cellulose based wrap, Bio-Shield®)
Gravity Displacement (Wrapped in two layers of
1-ply polypropylene wrap, Kimguard KC600)
TEMPERATURE
EXPOSURE TIME
DRY TIME
270°F (132°C)
4 Minutes
75 Minutes
270°F (132°C)
4 Minutes
30 Minutes
270°F (132°C)
15 Minutes
75 Minutes
STERILIZATION PARAMETERS FOR L-BOX 4-BLADED “CLOVER KOROS LATERAL RETRACTOR SET” (XLBX-03)
METHOD
CYCLE
TEMPERATURE
EXPOSURE TIME
Steam
Pre-Vacuum (Wrapped)
270°F (132°C)
4 Minutes
DRY TIME
60 Minutes
STERILIZATION PARAMETERS FOR L-BOX ‘KOROS DISCECTOMY INSTRUMENT SET” (XLBX-06)
METHOD
CYCLE
TEMPERATURE
EXPOSURE TIME
Steam
Pre-Vacuum (Wrapped)
270°F (132°C)
4 Minutes
DRY TIME
60 Minutes
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 equipment.
CAUTION: Federal Law (U.S.A) restricts these devices to sale by or on order of a physician.
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