Bone graft substitute - PRO-DENSE® Injectable Regenerative Graft by Wright Medical

Product Overview

Applications where PRO-DENSE® graft has been used:

Osseous Defects
Core Decompression procedures

Indications:

PRO-DENSE® resultant paste is intended for use as a bone graft substitute to be injected or digitally packed into open bone voids/gaps that are not intrinsic to the stability of bony structure of the skeletal system (i.e., the extremities, spine, and pelvis) to cure in situ. These open bone voids may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The paste provides a bone graft substitute that can be resorbed and replaced with bone during the healing process.

The PRO-DENSE® paste cured in situ provides an open void/gap filler that can augment provisional hardware (e.g. K-Wires) to help support bone fragments during the surgical procedure. The cured paste acts only as a temporary support media and is not intended to provide structural support during the healing process.

PRO-DENSE® paste is provided sterile for single use only.

Contraindications

The PRO-DENSE® Bone Graft Substitute injectable paste is contraindicated where the device is intended as structural support in load-bearing bone and in articulating surfaces. Conditions representing relative contraindications include:

Severe vascular or neurological disease
Uncontrolled diabetes
Severe degenerative bone disease
Closed bone void/gap filler
Pregnancy
Uncooperative patients who will not or cannot follow postoperative instructions, including individuals who abuse drugs and/or alcohol
Hypercalcemia
Renal compromised patients
Patients with a history of or active Pott’s disease

PRO-DENSE® Bone Graft Substitute is a synthetic biomaterial. Combining the bone forming capabilities of calcium sulfate with calcium phosphate has resulted in a composite graft that is delivering where other materials may fall short.

Intra-operative strength

Approximately 40MPa initial compressive strength
(at 2 hours, wet conditions)*

Reliable/consistent resorption

50% slower than pure calcium sulfate

Composite Makeup

75% CaSO₄

Primary osteoconductive filler
Resorbs first primarily through simple dissolution to allow early vascular infiltration

25% CaPO₄
(brushite and granular TCP)

Osteoclastic resorption
Secondary porous scaffold that is resorbed after primary filler
TCP granules are resorbed in the third and final phase

6-week PRO-DENSE® Graft Specimen

New blood vessels (arrows); note prominent osteoblastic rimming intimately associated with residual calcium sulfate and calcium phosphate (black) and TCP (grey).

(Canine proximal humerus, 9x15mm defect, basic fuchsine and toluidine blue, original mag 300x)

Data on file*

STRONGER THAN NORMAL BONE*: At 13 weeks; Urban, et al... CORR, June 2007.

* All claims are based on a critically sized canine proximal humerus defect model. It is unknown how results from the canine model compare with clinical results in humans.