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Allogran-R

FDA 510(k)

Class II (US FDA 510(k))

510(k) K061311

by Biocomposites Ltd

Identifiers

510(k) Number
K061311 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)

Allogran-R is a synthetic bone graft substitute composed of polycrystalline, porous tri-calcium phosphate granules and blocks. It is designed to support bone regeneration in trauma and spinal procedures by providing a scaffold for new bone formation.

The device is supplied sterile for single-patient use and is radiopaque, allowing for radiographic visualization. Manufactured from medical-grade tri-calcium phosphate, Allogran-R is biodegradable with resorption occurring over approximately 6–12 months when used as intended. It holds an FDA 510(k) clearance under the product code MQV and advisory committee classification OR.

Frequently asked questions

What types of surgical procedures is Allogran-R intended to support during bone regeneration?

Allogran-R is designed to support bone regeneration in trauma and spinal procedures by acting as a scaffold for new bone growth. Its porous structure allows cells to infiltrate and form new tissue, making it suitable for filling defects or augmenting bone during these specific surgical contexts.

Is Allogran-R reusable, or is it meant for single-patient use only?

Allogran-R is explicitly supplied sterile for single-patient use only. This ensures safety and sterility for each individual procedure, preventing cross-contamination or degradation between uses.

How long does it typically take for Allogran-R to resorb after being implanted?

Allogran-R is biodegradable, with resorption occurring over approximately 6–12 months when used as intended. This timeline allows sufficient time for new bone formation to integrate with the scaffold before it fully breaks down.

Can Allogran-R be visualized using X-rays, and how does this benefit the procedure?

Yes, Allogran-R is radiopaque, meaning it can be visualized using radiographic imaging. This allows surgeons to confirm proper placement and monitor integration during and after surgery, improving procedural accuracy and follow-up assessments.

What forms does Allogran-R come in, and how is it packaged for clinical use?

Allogran-R is supplied as porous tri-calcium phosphate granules and blocks. The exact packaging details aren’t specified, but its sterile, single-use nature suggests it is likely pre-packaged in sterile containers to maintain sterility until use.

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: Allogran-R® Synthetic Bone Substitute | Biocomposites, BIOCOMPOSITES LTD 800-010 Allogran-R® - RevMed, BIOCOMPOSITES LTD 800-010 Allogran-R® - RevMed

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Biocomposites Ltd
FDA Applicant
Biocomposites, Ltd.

Sources (1)

  • FDA 510(k) K061311 24 fields · synced Sep 19, 2026