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AFT Allograft Filler Tube

FDA 510(k)

Class II (US FDA 510(k))

510(k) K060161

by Musculoskeletal Transplant Foundation

Identifiers

510(k) Number
K060161 FDA 510(k)
FDA Product Code
MBP 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 AFT Allograft Filler Tube is a bone void filler classified as an Osteoinduction (W/O Human Growth Factor) device, designed to promote bone regeneration. It consists of processed osteoconductive allograft tissue, which provides structural support and facilitates new bone formation through its inherent osteoinductive properties, as demonstrated in preclinical models.

This device is supplied as a sterile, single-use medical implant intended for orthopedic applications. It is manufactured by the Musculoskeletal Transplant Foundation and has received FDA 510(k) clearance under product code MBP. Each lot undergoes in vivo testing to confirm osteoinductive potential before distribution. Storage and handling must comply with sterile medical device protocols to maintain integrity.

Frequently asked questions

What is the primary purpose of the AFT Allograft Filler Tube in orthopedic procedures?

The AFT Allograft Filler Tube is designed to promote bone regeneration by filling bone voids. It uses processed osteoconductive allograft tissue, which provides structural support and encourages new bone formation through its inherent osteoinductive properties—meaning it stimulates the body’s own cells to grow new bone, as demonstrated in preclinical testing.

Is the AFT Allograft Filler Tube intended for reuse, or is it meant to be used only once?

The AFT Allograft Filler Tube is explicitly labeled as a single-use medical implant. This classification ensures sterility and safety for one-time surgical application, aligning with standard sterile medical device protocols.

How is sterility maintained for the AFT Allograft Filler Tube, and what storage precautions should be followed?

The device is supplied as sterile to meet medical implant standards. To preserve sterility, storage and handling must comply with sterile medical device protocols, including proper packaging integrity and environmental controls, as outlined in the manufacturer’s instructions.

What regulatory pathway was followed for FDA clearance of the AFT Allograft Filler Tube?

The AFT Allograft Filler Tube received FDA 510(k) clearance under product code MBP (Musculoskeletal, Bone Void Fillers) via a Traditional 510(k) review. The submission was classified as *Substantially Equivalent* to a predicate device and reviewed by the Orthopedic (OR) Advisory Committee. Clearance was granted on March 21, 2006.

Does the AFT Allograft Filler Tube undergo any testing before distribution to ensure its effectiveness?

Yes, each lot of the AFT Allograft Filler Tube undergoes in vivo testing to confirm its osteoinductive potential before distribution. This testing validates the device’s ability to promote bone regeneration in a living organism, ensuring consistency with its intended performance.

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 AFT Allograft Filler Tube AFT-DS Allograft Filler Tube - mtfbiologics.org, PDF PI -9 Rev 12 - mtfbiologics.org, AFT Allograft Filler Tube - Musculoskeletal Transplant Foundation | FDA ..., PDF MAR K 060/6/ - Food and Drug Administration

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Musculoskeletal Transplant Foundation

Sources (1)

  • FDA 510(k) K060161 24 fields · synced Sep 19, 2026