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inCORPorate
™ CORPECTOMY VERTEBRAL
BODY REPLACEMENT SYSTEM
SURGICAL TECHNIQUE GUIDE
THORACOLUMBAR
INTERBODY DEVICES
inCORPorate™
Surgical Technique Guide
Table of Contents
Features & Benefits
3
Instrument Guide
4-6
Surgical Technique Guide
7-10
Indications/Contraindications/Warnings
11-12
1755 West Oak Parkway
Marietta, GA 30062
Phone: 877-755-3329
Fax: 877-420-1213
www.Amendia.com
[email protected]
Disclaimer:
The surgical technique shown is for illustrative purposes only. The technique(s) actually employed in each case will always depend upon the
medical judgment of the surgeon before and during surgery as to the best mode of treatment for each patient. Please reference the 510K or
package insert for additional information and a complete list of intended indications, warnings, precautions, and other medical information.
Superior endplate coverage & graft retention.
The inCORPorate™ Corpectomy Vertebral Body Replacement System restores the biomechanical
integrity of the anterior, middle, and posterior spinal column. This helps to achieve anterior
decompression of the spinal cord and neural tissues, and to restore the height of a collapsed
vertebral body. Ridges in both the superior and inferior directions resist implant migration while
the implant cavities accept packing of the graft material.
Features & Benefits
•Constructed of PEEK
•Tantalum radiopaque markers to optimize visibility
and placement
•Anti-backout ridges provide resistance to migration
•Hollow core allows for large amounts of graft
material to facilitate fusion
•Design ensures a high degree of compressive
strength and dimensional stability
inCORPorate
™
CORPECTOMY VERTEBRAL
BODY REPLACEMENT SYSTEM
14x12mm Footprint, Anterior Insertion
Part No.
HH (Height)
104-1-1412HHV 14-50 (In 2mm Increments)
V (Lordosis)
0°, 10°
17x14mm Footprint, Anterior Insertion
Part No.
HH (Height)
104-1-1714HHV 14-50 (In 2mm Increments)
V (Lordosis)
0°, 10°
17x14mm Footprint, Anterior & Lateral Insertion
Part No.
HH (Height)
104-2-1714HHV 14-50 (In 2mm Increments)
V (Lordosis)
0°, 10°
For more information or to place an order call 1-877-755-3329, email [email protected] or visit amendia.com
3
Instrument Guide
4
Implant & Instrument Guide
Graft Compactor
104-13
QTY/Tray: 1
Inserter Inner Shaft
8177-2-3
QTY/Tray: 2
Inserter Outer Shaft
8177
QTY/Tray: 2
One-Sided Rasp (14mm W x 12mm L x 5mm H)
8178-5-1412X-05P
QTY/Tray: 2
5
Implant & Instrument Guide
Mini Inserter Tool
9115
QTY/Tray: 1
Corpectomy Caliper
PI-2100
QTY/Tray: 1
Graft Packing Block
011-01-1
QTY/Tray: 1
6
Surgical Technique
Guide
7
Surgical Technique Guide
Exposure
Obtain anterior exposure per surgeon preference.
Expose the midline of the intervertebral disc above and below the vertebrectomy site and remove the
appropriate amount of disc and vertebral body.
Adequate preparation of the endplates is important to enhance vascular supply to the fusion site
(Figure 1a, 1b).
Note: Aggressive cleaning of the endplate may remove excess bone and weaken the endplate.
Figure 1a
Trialing
Figure 1b
After the endplates and vertebral body are prepared, the Caliper is used to approximate the appropriate
size of the inCORPorate™ Corpectomy Vertebral Body Replacement System (Figure 2). Once the
appropriate size has been determined, the comparable Implant is selected.
Figure 2
8
Surgical Technique Guide
Implantation
Load the inCORPorate™ Corpectomy Vertebral Body Replacement System onto the Inserter by aligning
the distal tip up with the alignment holes of the Implant (Figure 3). After attaching the Inserter to the
Implant, fill the Implant cavity with autograft and/or allograft bone. Use the Graft Compactor to aid in
packing the graft material into the Implant.
Figure 3
Introduce the Implant into the vertebral space using the Inserter (Figure 4).
.
Figure 4
Final positioning of all Implant(s) should be confirmed using fluoroscopy. Additional autograft and/or
allograft bone may be placed around the Implants at the surgeon’s discretion.
9
Surgical Technique Guide
Supplemental Fixation
Because additional fixation considerably enhances the biomechanical stability of the motion segment
as well as the stability of the Implant, the inCORPorate™ Corpectomy Vertebral Body Replacement
System must be used in conjunction with supplemental fixation.
The final steps of the fixation procedure (e.g. rod insertion, tightening, compression) are completed after
implantation of the Implant. Please refer to the specific system’s surgical technique manual for user
instructions.
Revision Surgery (Implant Removal)
Device removal can be achieved by threading the Inserter into the Implant. Meticulous removal of all
autograft and/or allograft is required prior to attempting to move the device within the vertebral space.
A larger annulotomy and/or bone window may be required to accomplish this.
With the Inserter threaded securely onto the Implant, a light rocking motion can be used to loosen the
Implant. Once the Implant is loosened, remove it by pulling the Inserter in an upward motion away from
the spine. Care should be taken so as not to injure the adjacent soft tissue and nerve structures.
10
Indications/Contraindications/Warnings
INDICATIONS
The inCORPorate™ Corpectomy Vertebral Body Replacement System is a vertebral body replacement
system indicated for use to replace a vertebral body that has been resected or excised due to tumor or trauma/
fracture. The device is intended for use as a vertebral body replacement in the thoracolumbar spine (from T1 to
L5). Corpectomy Vertebral Body Replacement System is intended for use with supplemental fixation cleared for
use in the thoracolumbar spine and is to be used with autograft and/or allograft.
CONTRAINDICATIONS
Include, but are not limited to:
• Fractures
• Scoliosis
• Active infection
• Allergy to tantalum, PEEK or Titanium Alloy (Ti6Al4V ELI)
• Bone tumors in the region where the implant would have to be anchored
• Unwillingness or inability of the patient to follow the instructions for postoperative treatment
• Any medical or surgical condition that could preclude the potential success of the implantation
• Pregnancy
• Osteoporosis or similar loss of bone density
• Systemic or metabolic diseases
• Drug abuse or alcoholism
• Generally poor condition of the patient
• Morbid obesity
• Psychosocial issues; inadequate co-operation by the patient
• Fever or leukocytosis
• Any case not needing a fusion
• Patients with a known hereditary or acquired bone friability or calcification problem should not be considered
for this type of surgery
• These devices must not be used for pediatric cases, nor where the patient still has general skeletal growth
• Any case where the implant components selected for use would be too large or too small to achieve a
successful result
• Any case that requires the mixing of metals from two different components or systems
• Any patient having inadequate tissue coverage over the operative site or inadequate bone stock or quality
• Any patient in which implant utilization would interfere with anatomical structures or expected physiological
performance
• Prior fusion at the level to be treated
• All cases that are not listed under indications
11
Indications/Contraindications/Warnings
WARNING
1. 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.
2. IMPLANTS CAN BREAK WHEN SUBJECTED TO THE INCREASED LOADING ASSOCIATED WITH DELAYED UNION
OR NONUNION. Internal fixation appliances are load-sharing devices that 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 or 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.
SEE PACKAGE INSERT/INSTRUCTIONS FOR USE FOR FULL CLEANING AND STERILIZATION INSTRUCTIONS
12
1755 West Oak Parkway
Marietta, GA 30062
Phone: (877) 755-3329
Fax: (877) 420-1213
www.Amendia.com
[email protected]
MM-129 Rev.1