CopiOs® Bone Void Filler

Description

CopiOs Bone Void Filler Sponge is a synthetic bone graft material consisting of mineralized, lyophilized collagen that has been formed into sponges of various sizes for surgical implantation. CopiOs Sponge consists of calcium phosphate within lyophilized type I bovine collagen sponges. The sponges are approximately 67% mineral by weight. The sponges are sized in 1cc (1 x 2 x 0.5cm) and 5cc (2 x 5 x 0.5cm) volumes. When in contact with viable bone at the defect site, CopiOs Sponge will act as an osteoconductive scaffold for the growth of new bone. As new bone growth occurs, the scaffold is resorbed.

CopiOs Bone Void Filler Paste is a synthetic bone graft material consisting of mineralized, lyophilized collagen particles that have been formed into compressed powder discs of various sizes. CopiOs Paste is mixed into a putty consistency prior to surgical implantation. CopiOs Paste consists of calcium phosphate within lyophilized type I bovine collagen and is approximately 67% mineral by weight. CopiOs Paste is provided in three sizes (1cc, 5cc, and 10cc volumes). When in contact with viable bone at the defect site, CopiOs Paste will act as an osteoconductive scaffold for the growth of new bone. As new bone growth occurs, the scaffold is resorbed.

Indications

CopiOs Sponge, in combination with autologous blood products such as bone marrow, is intended for use only for filling bone voids or gaps of the skeletal system (i.e., extremities, pelvis, spine, i.e., posterolateral spine fusion procedures with appropriate stabilizing hardware) that are not intrinsic to the stability of the bone structure. These voids may be a result of trauma or creation by surgeon. CopiOs Sponge is intended to be gently packed into the void or gap and will resorb during the course of the healing process. CopiOs Sponge is intended to be used by surgeons practiced in bone grafting and rigid fixation techniques for stabilizing bone voids.

CopiOs Paste, in combination with autologous blood products such as bone marrow, is intended for use only for filling bone voids or gaps of the skeletal system (i.e., extremities, pelvis and spine, i.e., posterolateral spine fusion procedures with appropriate stabilizing hardware) that are not intrinsic to the stability of the bone structure. These voids may be a result of trauma or creation by surgeon. CopiOs Paste is intended to be gently packed into the void or gap and will resorb during the course of the healing process. CopiOs Paste is intended to be used by surgeons practiced in bone grafting and rigid fixation techniques for stabilizing bone voids.

Contraindications

CopiOs Paste is contraindicated for the following conditions:

• Infection at the surgical site 
• Segmental defects
• Significantly impaired vascularity proximal to surgical site 
• Sites in direct contact with articular space
• Systemic conditions which affect bone or wound healing 
• Patients with history of multiple allergies
• Patients with known allergies to bovine collagen
• Sites where stresses on void will exceed the load strength of fixation hardware 
• Severe degenerative bone disease
• Hypercalcemia 
• Pregnancy

CopiOs Paste:

• CopiOs Paste should not be used in large bone voids that the surgeon does not believe would heal spontaneously 
• CopiOs Paste does not have mechanical strength that would permit load-bearing applications of any type
• Rigid fixation of the defect site is recommended for proper stabilization of the bone void

CopiOs Sponge:

• CopiOs Sponge should not be used in large bone voids that the surgeon does not believe would heal spontaneously 
• CopiOs Sponge does not have mechanical strength that would permit loadbearing applications of any type
• Rigid fixation of the defect site is recommended for proper stabilization of the bone void

CopiOs Paste:

• For single use only 
• Do not resterilize
• Do not mix excessive amount of fluid into CopiOs Paste

CopiOs Sponge:

• For single use only 
• Do not resterilize

USA: 720-894-9016

To submit a complaint, please email SpineComplaints@zimvie.com

10225 Westmoor Dr. Westminster, CO 80021 USA

To obtain a copy of the current Instructions for Use (IFU) for full prescribing and risk information, please call 720-894-9016.

1. Data on File.*
2. Fernandez E, et al. Calcium phosphate bone cements for clinical applications – Part I: Solution chemistry. J Mater Sci Mater Med. 1999; 10:169-176.
3. LeGeros R. Biodegradation and bioresorption of calcium phosphate ceramics. Clin Mater. 1993; 14(1):65-88.

Animal testing of products is not necessarily predictive of clinical outcomes in humans.

* Findings from in vitro experiments are not necessarily predictive of human clinical results

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