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:
- age of the patient
- quality of the patient’s bone
- location of the defect
- anticipated loading
conditions
- proximity of the graft to a suitable blood
supply
- ability to achieve direct apposition of the graft to
viable host bone
- presence/addition of autogenous bone or
bone marrow at the graft site
- elimination of gaps in the
graft site
- ability to suitably stabilize the graft
site
- 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:
- 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
- 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.