Pro Osteon® Bone Graft Substitute

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200R

Pro Osteon 200R is a resorbable, osteoconductive matrix consisting of hydroxyapatite and calcium carbonate. Originally cleared for use in oral maxillofacial procedures as a very slow resorbing material, the faster-resorbing Pro Osteon 200R is indicated as a bone graft substitute that resorbs and is replaced with bone during the healing process. Its interconnected porosity, chemical composition and resorbtion time make Pro Osteon 200R an environment for new bone growth.

  • The 200R variant is significantly resorbed in approximately 6-18 months*
  • Full 200 micron (average) interconnected porosity provides continuous pathways for bony ingrowth 
  • Small granules (.5-1mm), convenient for filling small defects
  • Morphology and chemical composition similar to human bi-cortical bone
  • FDA indicated to be packed into bony voids or gaps that are not intrinisic to the stability of the skeletal system
  • Requires no special handling or reconstitution and is shipped sterile, ready-to-use

*  Walsh, W.R., et al., A resorbable porous ceramic composite bone graft substitute in a rabbit metaphyseal defect model. Journal of Orthopaedic Research, Volume 21, Issue 4, 2003, Pages 655-661.

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500R

Osteoconductive

  • Osteoconductive matricies consisting of a thin, 2-10 micron layer of hydroxyapatite over a calcium carbonate core. Provides a natural scaffold for new bone growth when placed in contact with viable bone.

Bone Void Filler

  • Cleared as a bone void filler to be packed into bony voids or gaps in the skeletal system that are not intrinsic to the stability of the bone structure.

 

Indications

Product Description

PRO OSTEON 200R Resorbable Bone Graft Substitute is an osteo-conductive porous implant similar in structure to human cancellous bone. It is supplied sterile in various shapes and sizes. PRO OSTEON 200R Resorbable Bone Graft Substitute has a trabecular structure with multidirectional interconnected porosity with an approximate pore diameter of 190-230 microns. The product consists of an underlying calcium carbonate matrix covered by a very thin outer layer of calcium phosphate, approximately 2 to 10 microns in thickness. The calcium phosphate is located on the outer surface of the porosity throughout the entire structure of the implant. Once implanted, the calcium phosphate outer layer will slowly resorb, delaying exposure of the underlying and faster resorbing calcium carbonate. When PRO OSTEON 200R Resorbable Bone Graft Substitute is placed in direct contact with viable bone, the reticulated spaces in the implant are infiltrated with tissue. Bone formation occurs in apposition to the calcium phosphate surface and within the interstices of the implant. As the implant resorbs, bone and soft tissue grow into the space previously occupied by the calcium carbonate.

PRO OSTEON 500R Resorbable Bone Graft Substitute is an osteoconductive porous implant similar in structure to human cancellous bone. It is supplied sterile in various shapes and sizes.

PRO OSTEON 500R Resorbable Bone Graft Substitute has a trabecular structure which resembles the multidirectional interconnected porosity of cancellous bone. It has a median pore diameter of 435 microns. The implant is trabecular calcium carbonate covered by a very thin layer of calcium phosphate. The calcium phosphate is located on the outer surface of the porosity throughout the entire structure of the implant. It is approximately 2 to 10 microns in thickness and overlays the calcium carbonate substructure. Once implanted, this layer will slowly resorb, delaying exposure of the underlying and faster resorbing calcium carbonate. Calcium carbonate resorption will normally occur within 6 months or less.

When PRO OSTEON 500R Resorbable Bone Graft Substitute is placed in direct contact with viable bone, the reticulated spaces in the implant are infiltrated with tissue. Bone formation occurs in apposition to the calcium phosphate surface and within the interstices of the implant. As the implant resorbs, bone and soft tissue grow into the space previously occupied by the calcium carbonate.*

 

Instructions for Use

These instructions are intended as guidelines for the use of PRO OSTEON 200R Resorbable Bone Graft Substitute as a part of established surgical techniques. They are not intended to replace or change standard procedures for treatment of bone defects involving bone grafting and internal  fixation. Procedures involving bone grafting can experience highly variable results. Factors to be considered in selecting the bone grafting material and the surgical technique to be utilized are as follows:

  1. age of the patient
  2. quality of the patient’s bone
  3. location of the defect
  4. anticipated loading conditions
  5. proximity of the graft to a suitable blood supply
  6. ability to achieve direct apposition of the graft to viable host bone
  7. presence/addition of autogenous bone or bone marrow at the graft site
  8. elimination of gaps in the graft site
  9. ability to suitably stabilize the graft site
  10. complete coverage of the graft material to prevent migration

For best results, extreme care should be exercised to assure the correct graft material is selected for the intended application.

PRO OSTEON® 500R Resorbable Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. PRO OSTEON 500R is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.

PRO OSTEON® 500R can be combined with autogenous bone marrow aspirate, autogenous blood, and/or sterile fluids (saline or Ringer’s solution). The product provides a bone void filler that resorbs and is replaced with bone during the healing process.

 

Contraindications

PRO OSTEON 200R Resorbable Bone Graft Substitute is contraindicated:

  1. for fractures of the growth plate
  2. for segmental defects
  3. for indications which may be subjected to excessive impact or stresses
  4. when there is significant vascular impairment proximal to the graft site
  5. when there are metabolic or systemic bone disorders that affect bone or wound healing
  6. in infected sites
  7. when stabilization of the defect is not possible.

The use of PRO OSTEON 200R is also contraindicated in cases where intraoperative soft tissue coverage is not planned or possible.

PRO OSTEON 500R Resorbable Bone Graft Substitute is contraindicated for fractures of the growth plate; for segmental defects; for indications which may be subjected to excessive impact or stresses; when there is significant vascular impairment proximal to the graft site; when there are metabolic or systemic bone disorders that affect bone or wound healing; in infected sites; or when stabilization of the defect is not possible. The use of PRO OSTEON 500R is also contraindicated in cases where intraoperative soft tissue coverage is not planned or possible.

 

Warnings and Precautions

PRO OSTEON 200R Resorbable Bone Graft Substitute does not possess sufficient mechanical strength to support reduction of a defect site prior to soft and hard tissue ingrowth. Rigid fixation techniques are recommended as needed to assure rigid stabilization of the defect in all planes. PRO OSTEON 200R Resorbable Bone Graft Substitute is intended for use by surgeons familiar with bone grafting and rigid fixation techniques. Complete postoperative wound closure is essential. PRO OSTEON 200R is radiopaque until resorbed. Radiopacity may mask underlying pathological conditions. Radiopacity may also make it difficult to radiographically assess the ingrowth of new bone.

PRO OSTEON 500R Resorbable Bone Graft Substitute does not possess sufficient mechanical strength to support reduction of a defect site prior to soft and hard tissue ingrowth. Rigid fixation techniques are recommended as needed to assure rigid stabilization of the defect in all planes. PRO OSTEON 500R Resorbable Bone Graft Substitute is intended for use by surgeons familiar with bone grafting and rigid fixation techniques. Complete postoperative wound closure is essential.

PRO OSTEON 500R is radiopaque until resorbed. Radiopacity may mask underlying pathological conditions. Radiopacity may also make it difficult to radiographically assess the ingrowth of new bone.

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