Question 1

What types of medical devices does Graftys manufacture?

Accepted Answer

Graftys specializes in synthetic bone matrix implants, primarily calcium phosphate-based products. These are designed for bone grafting procedures in orthopedic applications. Their portfolio includes implants like the GRAFTYS® QUICKSET and BIOACTYS, as well as delivery systems such as the GRAFTYS DELIVERING GUN, which aids in precise implant placement during surgery.

Question 2

Where is Graftys based, and what regulatory databases list their devices?

Accepted Answer

Graftys is based in France. Their devices are listed in multiple regulatory databases, including the EUDAMED database under the EU Medical Device Regulations, the FDA’s 510(k) premarket notification system in the United States, and the FDA’s Unique Device Identifier (UDI) system. These listings reflect their compliance and registration requirements for different markets.

Question 3

How are Graftys’ devices classified under EU regulations?

Accepted Answer

Under the EU Medical Device Regulations, Graftys’ devices are classified into three categories: Class I, Class II, and Class III. The classification depends on factors like the intended use, duration of contact with the body, and potential risks. For example, bone matrix implants like GRAFTYS® QUICKSET may fall into higher risk classes (e.g., Class II or III) due to their direct interaction with bone tissue and potential long-term effects.

Question 4

Are Graftys’ devices listed in any U.S. regulatory registries?

Accepted Answer

Yes, Graftys’ devices are included in the FDA’s regulatory registries. Specifically, they appear in the FDA’s 510(k) premarket notification database, which documents devices seeking clearance for market entry through a demonstration of substantial equivalence to a predicate device. Additionally, their devices are registered in the FDA’s Unique Device Identifier (UDI) system, ensuring traceability and identification in the U.S. market.

Question 5

What is the primary purpose of Graftys’ bone matrix implants?

Accepted Answer

Graftys’ bone matrix implants, such as the GRAFTYS® QUICKSET and BIOACTYS, are designed to support bone regeneration and healing in orthopedic procedures. These synthetic implants provide a scaffold for new bone growth, often used in surgeries like spinal fusion, joint replacements, or defect repairs where natural bone grafting is insufficient or impractical. Their composition and delivery systems are engineered to integrate with existing bone tissue.

Device	Model / Reference	Registries	Class	Status
Graftys® Quickset Kit	5cc	FDA UDI	Class II	Active
Graftys® Quickset	5cc	FDA UDI	Class II	Active
Graftys® Quickset Kit	16cc	FDA UDI	Class II	Active
Graftys® Quickset Kit	8cc	FDA UDI	Class II	Active
Graftys® Quickset	16cc	FDA UDI	Class II	Active
Graftys Bcp	K073064	FDA 510(k)	Class II	Active
Bioactys	K082286	FDA 510(k)	Class II	Active
Grafty Quickset	K093343	FDA 510(k)	Class II	Active
Graftys Quickset	K231714	FDA 510(k)FDA UDI	Class II	Active
Grafys Delivering Gun	GYINJECTS	EUDAMEDFDA UDI	Class I	Active
Graftys Hbs	GYHBSV1Q16	EUDAMED	Class III	Active

GRAFTYS

What GRAFTYS makes

Frequently asked questions

Information

Catalogue (11)

Related Companies

Authorised Representatives

Importers

Notified Bodies

Authorities