Pore-Si Bone Graft Substitute
FDA 510(k)Class II (US FDA 510(k))
by Apatech Ltd
Identifiers
- 510(k) Number
- K040082 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 Pore-Si Bone Graft Substitute is a phase-pure, porous hydroxylapatite bone void filler classified as an osteoconductive scaffold. It mimics the structure of human cancellous bone to facilitate bone regeneration and repair in skeletal voids or gaps.
Supplied as irregular chips or granules, the device is manually packed by surgeons into non-structural skeletal defects in extremities, the spine, or pelvis. It is resorbable, gradually replaced by natural bone over time, and has received FDA 510(k) clearance under product code MQV with K-number K040082.
Frequently asked questions
What types of skeletal defects is the Pore-Si Bone Graft Substitute designed to address, and how is it applied during surgery?
The Pore-Si Bone Graft Substitute is intended for non-structural skeletal defects in extremities, the spine, or pelvis where bone regeneration is needed. It is supplied as irregular chips or granules and is manually packed by surgeons into the defect site to act as an osteoconductive scaffold, mimicking cancellous bone structure to support natural bone repair.
How is the Pore-Si Bone Graft Substitute different from traditional bone grafts, and what happens to it over time?
Unlike traditional bone grafts, the Pore-Si Bone Graft Substitute is a resorbable, synthetic hydroxylapatite scaffold designed to gradually degrade and be replaced by the patient’s own natural bone over time. Its porous structure promotes osteoconduction, guiding new bone growth into the defect without requiring removal.
Is the Pore-Si Bone Graft Substitute single-use or reusable, and how should it be stored?
The Pore-Si Bone Graft Substitute is intended for single-use only. Since it is supplied as sterile irregular chips or granules, it should be stored in a dry, sealed container as directed by the manufacturer to maintain sterility until use.
What regulatory pathway was followed for FDA clearance of the Pore-Si Bone Graft Substitute, and what does that mean for its use?
The Pore-Si Bone Graft Substitute received FDA clearance through a 510(k) pathway under product code MQV (Orthopedic Devices) with the designation Substantially Equivalent (SESE). This means the device was determined to have the same intended use and technological characteristics as a legally marketed predicate device, ensuring it meets FDA safety and effectiveness standards for its designated applications.
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: PORE-SI BONE GRAFT SUBSTITUTE 510 (k) K040082 - FDA.report, PDF 510(k) Summary oSZ. AUG -4 2004 - Food and Drug Administration, PORE-SI BONE GRAFT SUBSTITUTE (K040082) — FDA 510(k) | Innolitics, Pore-si Bone Graft Substitute - Beudamed
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K040082 | Class II | Active |
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Manufacturer
- Manufacturer
- Apatech Ltd
- FDA Applicant
- Apatech , Ltd.
Sources (1)
- FDA 510(k) K040082 24 fields · synced Sep 19, 2026