Question 1

What types of medical devices does Conventus Orthopaedics manufacture?

Accepted Answer

Conventus Orthopaedics specializes in internal orthopaedic fixation systems, specifically non-bioabsorbable plates and screws designed for bone stabilization. Their product line includes cannulated screws (with or without locking mechanisms), cortical screws, and proximal humerus (PH) locking plates. These devices are intended for surgical use in orthopaedic procedures to secure bone fragments or fractures.

Question 2

Where is Conventus Orthopaedics based, and how does that affect its regulatory standing?

Accepted Answer

Conventus Orthopaedics is based in the United States. Since it operates within the US market, its devices are subject to FDA regulations. The company’s products are classified as Class II under FDA guidelines, meaning they pose moderate risk and require pre-market clearance (e.g., via 510(k)) or compliance with the FDA’s Unique Device Identification (UDI) system to demonstrate safety and effectiveness.

Question 3

Which regulatory registries list Conventus Orthopaedics’ devices, and why?

Accepted Answer

Conventus Orthopaedics’ devices are listed in the FDA’s 510(k) and Unique Device Identification (UDI) registries. These registries track authorised medical devices in the US. The 510(k) pathway confirms that a device is substantially equivalent to a legally marketed predicate device, while UDI ensures traceability and transparency in the supply chain, supporting post-market surveillance and compliance.

Question 4

How are Conventus Orthopaedics’ orthopaedic fixation devices classified under FDA regulations?

Accepted Answer

Conventus Orthopaedics’ internal orthopaedic fixation systems, such as plates and screws, are classified as Class II devices by the FDA. This classification is based on their intended use—providing structural support to bones during healing—where the risk is moderate but requires validation of performance and safety through regulatory pathways like 510(k) clearances or UDI compliance to ensure patient safety.

Question 5

Are Conventus Orthopaedics’ devices available in sterile and non-sterile forms, and why does this matter?

Accepted Answer

Yes, Conventus Orthopaedics offers its orthopaedic fixation systems in both sterile and non-sterile versions. Sterility is critical for surgical applications where devices come into direct contact with the body’s sterile environments (e.g., open wounds or internal fixation). Non-sterile versions may be used in settings where pre-surgical preparation or immediate use isn’t required, though they must still meet regulatory standards for safety and efficacy.

Device	Model / Reference	Registries	Class	Status
3.5mm x 56mm Cortex Screw	SC3556	FDA UDI	Class II	Active
3.5mm x 66mm Cannulated Headed Screw	CH3566	FDA UDI	Class II	Active
3.5mm x 48mm Cannulated Locking Screw	CL3548	FDA UDI	Class II	Active
Locking Plate, PH, 112mm	7098-1	FDA UDI	Class II	Active
2.7mm x 26mm Cannulated Tapered-Head Screw	FS26	FDA UDI	Class II	Active
2.7mm x 36mm Cannulated Headed Screw	BH2736	FDA UDI	Class II	Active
2.7mm x 30mm Cannulated Tapered-Head Screw	FS30	FDA UDI	Class II	Active
3.5mm x 38mm Cortex Screw	SC3538	FDA UDI	Class II	Active
3.5mm x 42mm Locking Screw	SL3542	FDA UDI	Class II	Active
3.5mm x 64mm Cannulated Headed Screw	CH3564	FDA UDI	Class II	Active
2.7mm x 40mm Cannulated Headed Screw	BH2740	FDA UDI	Class II	Active
3.5mm x 60mm Cannulated Headed Screw	CH3560	FDA UDI	Class II	Active
3.5mm x 16mm Cannulated Headed Screw	CH3516	FDA UDI	Class II	Active
3.5mm x 26mm Cannulated Headed Screw	CH3526	FDA UDI	Class II	Active
3.5mm x 52mm Cortex Screw	SC3552	FDA UDI	Class II	Active
2.7mm x 44mm Cannulated Headed Screw	BH2744	FDA UDI	Class II	Active
3.5mm x 40mm Locking Screw	SL3540	FDA UDI	Class II	Active
3.5mm x 14mm Cannulated Headed Screw	CH3514	FDA UDI	Class II	Active
Conventus Cage - Plate	PX01	FDA UDI	Class II	Active
3.5mm x 20mm Cortex Screw	SC3520	FDA UDI	Class II	Active
3.5mm x 38mm Cannulated Headed Screw	CH3538	FDA UDI	Class II	Active
3.5mm x 32mm Locking Screw	SL3532	FDA UDI	Class II	Active
3.5mm x 54mm Cannulated Headed Screw	CH3554	FDA UDI	Class II	Active
2.7mm x 10mm Cannulated Headed Screw	BH2710	FDA UDI	Class II	Active
3.5mm x 50mm Locking Screw	SL3550	FDA UDI	Class II	Active
3.5mm x 40mm Cannulated Headed Screw	CH3540	FDA UDI	Class II	Active
3.5mm x 54mm Locking Screw	SL3554	FDA UDI	Class II	Active
2.7mm x 32mm Cannulated Tapered-Head Screw	FS32	FDA UDI	Class II	Active
3.5mm x 36mm Cortex Screw	SC3536	FDA UDI	Class II	Active
3.5mm x 44mm Cannulated Headed Screw	CH3544	FDA UDI	Class II	Active
3.5mm x 48mm Cannulated Headed Screw	CH3548	FDA UDI	Class II	Active
3.5mm x 44mm Cannulated Locking Screw	CL3544	FDA UDI	Class II	Active
3.5mm x 20mm Cannulated Locking Screw	CL3520	FDA UDI	Class II	Active
3.5mm x 68mm Cannulated Headed Screw	CH3568	FDA UDI	Class II	Active
3.5mm x 30mm Cannulated Headed Screw	CH3530	FDA UDI	Class II	Active
3.5mm x 46mm Cannulated Locking Screw	CL3546	FDA UDI	Class II	Active
2.7mm x 20mm Cannulated Headed Screw	BH2720	FDA UDI	Class II	Active
Large Plate, PH	6486-1	FDA UDI	Class II	Active
3.5mm x 22mm Locking Screw	SL3522	FDA UDI	Class II	Active
2.7mm x 28mm Cannulated Headed Screw	BH2728	FDA UDI	Class II	Active
3.5mm x 28mm Cortex Screw	SC3528	FDA UDI	Class II	Active
3.5mm x 58mm Cannulated Headed Screw	CH3558	FDA UDI	Class II	Active
3.5mm x 22mm Cannulated Headed Screw	CH3522	FDA UDI	Class II	Active
3.5mm x 50mm Cannulated Headed Screw	CH3550	FDA UDI	Class II	Active
2.7mm x 36mm Cannulated Tapered-Head Screw	FS36	FDA UDI	Class II	Active
3.5mm x 30mm Cortex Screw	SC3530	FDA UDI	Class II	Active
2.7mm x 38mm Cannulated Tapered-Head Screw	FS38	FDA UDI	Class II	Active
2.7mm x 8mm Cannulated Headed Screw	BH2708	FDA UDI	Class II	Active
3.5mm x 36mm Locking Screw	SL3536	FDA UDI	Class II	Active
3.5mm x 30mm Locking Screw	SL3530	FDA UDI	Class II	Active

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