Your web browser is out of date. For the best experience on Zimmer websites please upgrade to the latest version of Internet Explorer, Chrome, or Firefox.

Zimmer, Inc.

CopiOs® Bone Void Filler

Product 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 with an optimal pH level for bone healing, and an abundance of localized soluble mineral ions to promote bone formation.  The mineralized, lyophilized collagen particles are 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, and10cc 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.

Features

Optimal pH Level for Bone Healing

  • CopiOs Bone Void Filler is comprised of calcium phosphate, dibasic (DICAL), and highly purified Type I bovine collagen
  • CopiOs Bone Void Filler provides a moderately acidic environment that promotes solubility of osteoinductive growth factors such as bone morphogenic proteins (BMPs) (Fig. 1)
  • More soluble BMPs may remain available for bone healing processes in the early stages of bone growth (Fig 1)
  • The concentration of soluble BMPs in calcium salt solution decreases substantially when hydroxyapatite (HA) or beta-tricalcium phosphate (ß-TCP) is present (Fig. 1)
  % BMPs Left in Solution
Control (No Mineral) 100%
CaHPO4 (DICAL) 76%
ß-Ca3(PO4)2 (ß-TCP) 23%
Ca5(PO4)3(OH) (HA) 15%

Fig. 1: Concentrations of BMPs in various calcium salt solutions1

Abundance of Localized Soluble Mineral Ions Promotes Bone Formation

  • DICAL provides significantly more calcium and phosphate ions at equilibrium than either ß-TCP or HA (Fig. 2)²
  • Abundance of localized soluble calcium and phosphate ions promotes bone formation³
Composition Soluble Bone Mineral Concentration
[Ca2+] μM [PO43-] μM
CaHPO4 (DICAL) 427.8 427.8
ß-Ca3(PO4)2 (ß-TCP) 0.87 0.58
Ca5(PO4)3(OH) (HA) 1.11 0.67

Fig. 2: Soluble mineral concentrations of various calcium salts at equilibrium based on their solubility product constants2

References

  1. Data on File at Zimmer, Inc.*
  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.

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

 

 ZS-SA0700-06_A

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 Sponge 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 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

Warnings

  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

Precautions

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

Adverse Events

All of the following are potential complications arising from bone grafting procedures or use of CopiOs Paste or CopiOs Sponge:

  • Infection and site drainage that are possible with any surgery
  • Osteomyelitis
  • Delayed or non-union of defect
  • Graft migration with or without formation of particulate debris
  • Hematoma
  • Continued pain at defect site
  • Refracture
  • Graft rejection
  • Deformity of the bone at the site
  • Failed healing of the bone void due to incorrect surgical technique, patient non-compliance postoperatively, and other unforeseen circumstances may also occur.