SPINAL elements

InCorporate CORPECTOMY System Implants and Instruments Instructions

6 Pages

Spinal Elements, Inc. · 3115 Melrose Dr., Suite 200 Carlsbad, CA 92010 · U.S.A. · 760.607.0121  InCorporate CORPECTOMY SYSTEM IMPLANTS AND INSTRUMENTS  This package insert covers the InCorporate Corpectomy System and Manual Surgical Instruments that are used for the implantation of this system. GENERAL INFORMATION The InCorporate Corpectomy System is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The implants have ridges or teeth in both the superior and inferior directions, which resist migration. The implants have cavities to accept packing of autograft and/or allograft. The entire structure is radiolucent so that healing can be assessed by normal radiographic methods. Additionally, radiotherapy can be performed immediately after surgery. The materials used in the implant are listed on the packages. Implants are made from either PEEK (polyetheretherketone) radiolucent material with embedded tantalum x-ray markers as specified in ASTM F2026 and ASTM F560, respectively or Titanium Alloy (Ti6Al4V ELI) as specified in ASTM F136. To ensure radiographic visibility for inspecting the implant position, they contain marker pins made of x- ray opaque implant material (Tantalum). INDICATIONS The InCorporate Corpectomy 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). InCorporate Corpectomy 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 1. Fractures 2. Scoliosis 3. Active infection 4. Allergy to tantalum, PEEK or Titanium Alloy (Ti6Al4V ELI) 5. Bone tumors in the region where the implant would have to be anchored 6. Unwillingness or inability of the patient to follow the instructions for postoperative treatment 7. Any medical or surgical condition that could preclude the potential success of the implantation 8. Pregnancy 9. Osteoporosis or similar loss of bone density 10. Systemic or metabolic diseases 11. Drug abuse or alcoholism 12. Generally poor condition of the patient 13. Morbid obesity 14. Psychosocial issues; inadequate co-operation by the patient 15. Fever or leukocytosis 16. Any case not needing a fusion 17. Patients with a known hereditary or acquired bone friability or calcification problem should not be considered for this type of surgery 18. These devices must not be used for pediatric cases, nor where the patient still has general skeletal growth 19. Any case where the implant components selected for use would be too large or too small to achieve a successful result 20. Any case that requires the mixing of metals from two different components or systems 21. Any patient having inadequate tissue coverage over the operative site or inadequate bone stock or quality 22. Any patient in which implant utilization would interfere with anatomical structures or expected physiological performance 23. Prior fusion at the level to be treated 24. All cases that are not listed under indications  LB-144  Page 1 of 6  Rev. 20211221
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File Name: SPINAL elements - LB-144 - InCorporate CORPECTOMY System Implants and Instruments Instructions - 2021-12 - 20211221.pdf

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