Actifuse Shape Bone Graft Substitute
FDA 510(k)Class II (US FDA 510(k))
by Apatech Ltd
Identifiers
- 510(k) Number
- K080736 FDA 510(k)
- FDA Product Code
- MQV FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3045 FDA 510(k)
- Regulation Number
- 888.3045 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Actifuse Shape Bone Graft Substitute is a phase-pure, silicon-substituted calcium phosphate bone void filler, classified as a bone graft substitute under the nomenclature authority. It is designed to promote osteostimulation and bone regeneration through its porous, cancellous-like structure, incorporating 0.8% silicon by weight to mimic natural bone composition.
This device is supplied as a resorbable polymer-matrix delivered bone filler, intended for orthopedic applications to fill bony voids or gaps in extremities, the pelvis, or spine. It may be used in conjunction with stabilizing hardware for posterolateral applications and is intended for single-use. The product holds an FDA 510(k) clearance under the Special review pathway for orthopedic devices, with K-number K080736.
Frequently asked questions
What types of bony defects or gaps is the Actifuse Shape Bone Graft Substitute intended to fill, and can it be used with stabilizing hardware?
The Actifuse Shape Bone Graft Substitute is designed to fill bony voids or gaps in extremities, the pelvis, or the spine. It can also be used in conjunction with stabilizing hardware for posterolateral applications, providing structural support while promoting bone regeneration through its porous, cancellous-like structure.
Is the Actifuse Shape Bone Graft Substitute intended for single-use or can it be reused?
The Actifuse Shape Bone Graft Substitute is explicitly intended for single-use only, as stated in its design specifications. This ensures sterility and safety for each patient procedure.
How does the silicon content in Actifuse Shape Bone Graft Substitute contribute to its function?
The Actifuse Shape Bone Graft Substitute contains 0.8% silicon by weight, which mimics the composition of natural bone. This silicon substitution is intended to enhance osteostimulation and support bone regeneration by promoting a biological response similar to that of native bone tissue.
What regulatory pathway was followed for the FDA clearance of this bone graft substitute?
The Actifuse Shape Bone Graft Substitute received FDA clearance under the Special Review Pathway for orthopedic devices, specifically through the Orthopedic (OR) Advisory Committee. The clearance was granted as substantially equivalent (SESE) under K-number K080736, with the submission filed in 2008.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PDF Bone Graft Substitute Instructions for Use- Important Product Information, ACTIFUSE SHAPE BONE GRAFT SUBSTITUTE - Innolitics, Actifuse Bone Graft Substitute | Baxter Pro US
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K080736 | Class II | Active |
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Manufacturer
- Manufacturer
- Apatech Ltd
- FDA Applicant
- Apatech , Ltd.
Sources (1)
- FDA 510(k) K080736 24 fields · synced Sep 19, 2026