Synthetic Ceramic
4D Synthetic Bone Graft
A bioactive, bioresorbable synthetic bone graft supplied as a pre-mixed ceramic putty. The only product in the range that contains no human or animal-derived material, for cases where an allograft is not the right answer.
Schematic representation of graft structure
Description
A bioactive, bioresorbable synthetic bone graft supplied as a pre-mixed putty. Unlike the rest of the catalogue it contains no human or animal-derived material: the graft is a trace silica-induced biphasic calcium phosphate ceramic — 80% hydroxyapatite and 20% β-tricalcium phosphate — supplied as granules suspended in an aqueous polymer gel.
The ceramic carries an interconnected porosity of approximately 75–80%. Rather than presenting cells only with an outer surface, the pore network runs through the granule, supporting osteointegration and the formation of osteocytes within the ceramic structure itself.
Resorption is paced by the natural bone remodelling process rather than by rapid dissolution, which is what allows denser new bone to form as the graft gives way. The putty consistency is formulated for the realities of the surgical field: it holds its shape, and it does not stick to surgical gloves.
Indications
- Orthopedic bone grafting
Benefits
- 01Contains no human or animal-derived material
- 02Interconnected porosity of approximately 75–80%
- 03Resorption paced by natural bone remodelling
- 04Pre-mixed and ready to use — no preparation
- 05Does not stick to surgical gloves
- 06Open, minimally invasive and pre-filled applicators
Technical Specifications
- Material
- Biphasic calcium phosphate ceramic, trace silica-induced
- Composition
- 80% hydroxyapatite / 20% β-tricalcium phosphate
- Porosity
- Approximately 75–80%, interconnected
- Form
- Pre-mixed putty — ceramic granules in aqueous polymer gel
- Animal-derived material
- None
- Quality system
- ISO 13485 and MDSAP certified
Ordering Information
4D Synthetic Bone Graft
| Catalog No. | Description | Size |
|---|---|---|
| 1DE-OBS-02 | Open-bore syringe | 2 cc |
| 1DE-OBS-05 | Open-bore syringe | 5 cc |
| 1DE-OBS-10 | Open-bore syringe | 10 cc |
| 1DE-MIS-05 | Minimally invasive syringe | 5 cc |
| 1DE-MIS-10 | Minimally invasive syringe | 10 cc |
| 1DE-BVX-03 | Pre-filled applicator | 3 cc |
| 1DE-BVX-10 | Pre-filled applicator | 10 cc |
Regulatory Status
4D Synthetic Bone Graft is a synthetic bone void filler rather than human tissue. It is cleared by the FDA under section 510(k) and is manufactured under an ISO 13485 and MDSAP certified quality system. Because it contains no human or animal-derived material it is not a human cell, tissue, or cellular and tissue-based product, and is not regulated under Section 361 of the Public Health Service Act.
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