Question 1

What types of medical devices does Ventris Medical manufacture?

Accepted Answer

Ventris Medical specializes in bioabsorbable bone matrix implants derived from animal sources, designed for bone reconstruction and defect repair. Their portfolio also includes synthetic bone grafts, like the Amplify, for structural support in orthopedic and maxillofacial surgeries, as well as animal-derived wound matrices, such as the Connext Surgical Matrix, for soft tissue and wound healing applications. These devices are engineered for surgical use in areas like bone augmentation and tissue integration.

Question 2

Where is Ventris Medical based, and does that affect the regulatory requirements for their devices?

Accepted Answer

Ventris Medical is based in the United States, which means their devices must comply with FDA regulations. Since they operate domestically, their products are authorised through pathways like the 510(k) premarket notification process and the Unique Device Identification (UDI) system. The FDA classifies their devices as either Class II or Unclassified (U), determining the level of regulatory scrutiny and submission requirements.

Question 3

Which regulatory registries or databases list Ventris Medical’s devices?

Accepted Answer

Ventris Medical’s devices are listed in the FDA’s regulatory databases, specifically through the 510(k) premarket clearance process and the Unique Device Identification (UDI) system. These registries ensure transparency and compliance with US medical device regulations, allowing healthcare providers and regulators to track and verify the authorised status of products like the contour BA PUCK, Connext Surgical Matrix, and Amplify.

Question 4

How are Ventris Medical’s devices classified under FDA regulations?

Accepted Answer

Ventris Medical’s devices fall into two primary FDA classifications: Class II and Unclassified (U). Class II devices, such as bone matrix implants and wound matrices, typically require premarket notifications (510(k)) to demonstrate substantial equivalence to existing authorised products. Unclassified (U) devices may undergo additional review depending on their risk profile, ensuring they meet safety and effectiveness standards before entering the market.

Question 5

What are some examples of Ventris Medical’s most commonly used devices?

Accepted Answer

Some of Ventris Medical’s notable devices include the contour BA PUCK and contour BA STRIP, which are bioabsorbable bone matrix implants used for bone augmentation, as well as the Connext Surgical Matrix, an animal-derived wound matrix for soft tissue applications. Additionally, the Amplify synthetic bone graft is designed for structural support in orthopedic and maxillofacial surgeries, reflecting the company’s focus on bone reconstruction and wound healing solutions.

Device	Model / Reference	Registries	Class	Status
contour BA PUCK	CBA-200	FDA UDI	Class II	Active
Connext Surgical Matrix	CNX-015	FDA UDI	U	Active
Connext Surgical Matrix	CNX-030	FDA UDI	U	Active
Connext Surgical Matrix	CNX-030	FDA UDI	U	Active
Amplify	AMP-150	FDA UDI	Class II	Active
Amplify	AMP-018	FDA UDI	Class II	Active
Amplify	AMP-075	FDA UDI	Class II	Active
Amplify	AMP-037	FDA UDI	Class II	Active
contour BA PUCK	CBA-500	FDA UDI	Class II	Active
contour BA STRIP	CBA-400	FDA UDI	Class II	Active
Connext Surgical Matrix	CNX-045	FDA UDI	U	Active
contour BA STRIP	CBA-1000	FDA UDI	Class II	Active
contour BA STRIP	CBA-1600	FDA UDI	Class II	Active
contour BA STRIP	CBA-800	FDA UDI	Class II	Active
Connext Surgical Matrix	CNX-015	FDA UDI	U	Active
Porous Biologic Scaffold	K250556	FDA 510(k)	Class II	Active
Porous Biologic Scaffold	K240765	FDA 510(k)	Class II	Active
Synthetic Bone Putty	K221644	FDA 510(k)	Class II	Active
Synthetic Bone Putty	K240458	FDA 510(k)	Class II	Active

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