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 32mm Cannulated Headed Screw	CH3532	FDA UDI	Class II	Active
2.7mm x 34mm Cannulated Headed Screw	BH2734	FDA UDI	Class II	Active
3.5mm x 26mm Locking Screw	SL3526	FDA UDI	Class II	Active
2.7mm x 20mm Cannulated Tapered-Head Screw	FS20	FDA UDI	Class II	Active
2.7mm x 34mm Cannulated Tapered-Head Screw	FS34	FDA UDI	Class II	Active
3.5mm x 18mm Cannulated Headed Screw	CH3518	FDA UDI	Class II	Active
2.7mm x 18mm Cannulated Headed Screw	BH2718	FDA UDI	Class II	Active
3.5mm x 34mm Cannulated Locking Screw	CL3534	FDA UDI	Class II	Active
3.5mm x 42mm Cortex Screw	SC3542	FDA UDI	Class II	Active
3.5mm x 24mm Cannulated Locking Screw	CL3524	FDA UDI	Class II	Active
3.5mm x 44mm Locking Screw	SL3544	FDA UDI	Class II	Active
Conventus Cage - PH, Small	PH-S	FDA UDI	Class II	Active
2.7mm x 48mm Cannulated Tapered-Head Screw	FS48	FDA UDI	Class II	Active
Locking Plate, PH, 86mm	7097-1	FDA UDI	Class II	Active
3.5mm x 34mm Cannulated Headed Screw	CH3534	FDA UDI	Class II	Active
Conventus Cage - PH, Large	PH-L	FDA UDI	Class II	Active
3.5mm x 28mm Locking Screw	SL3528	FDA UDI	Class II	Active
Locking Plate, PH, Short	PH-LPS	FDA UDI	Class II	Active
3.5mm x 38mm Cannulated Locking Screw	CL3538	FDA UDI	Class II	Active
2.7mm x 26mm Cannulated Headed Screw	BH2726	FDA UDI	Class II	Active
3.5mm x 40mm Cannulated Locking Screw	CL3540	FDA UDI	Class II	Active
2.7mm x 42mm Cannulated Tapered-Head Screw	FS42	FDA UDI	Class II	Active
3.5mm x 26mm Cannulated Locking Screw	CL3526	FDA UDI	Class II	Active
3.5mm x 28mm Cannulated Headed Screw	CH3528	FDA UDI	Class II	Active
3.5mm x 62mm Cannulated Headed Screw	CH3562	FDA UDI	Class II	Active
3.5mm x 44mm Cortex Screw	SC3544	FDA UDI	Class II	Active
2.7mm x 16mm Cannulated Headed Screw	BH2716	FDA UDI	Class II	Active
2.7mm x 50mm Cannulated Tapered-Head Screw	FS50	FDA UDI	Class II	Active
3.5mm x 52mm Cannulated Locking Screw	CL3552	FDA UDI	Class II	Active
3.5mm x 24mm Locking Screw	SL3524	FDA UDI	Class II	Active
3.5mm x 34mm Cortex Screw	SC3534	FDA UDI	Class II	Active
3.5mm x 26mm Cortex Screw	SC3526	FDA UDI	Class II	Active
Conventus Cage - PR, Small	PR-S	FDA UDI	Class II	Active
2.7mm x 24mm Cannulated Tapered-Head Screw	FS24	FDA UDI	Class II	Active
2.7mm x 42mm Cannulated Headed Screw	BH2742	FDA UDI	Class II	Active
3.5mm x 22mm Cannulated Locking Screw	CL3522	FDA UDI	Class II	Active
2.7mm x 46mm Cannulated Headed Screw	BH2746	FDA UDI	Class II	Active
3.5mm x 56mm Cannulated Locking Screw	CL3556	FDA UDI	Class II	Active
3.5mm x 50mm Cortex Screw	SC3550	FDA UDI	Class II	Active
Conventus Cage - DR, Large	DRS-L	FDA UDI	Class II	Active
2.7mm x 12mm Cannulated Headed Screw	BH2712	FDA UDI	Class II	Active
3.5mm x 36mm Cannulated Locking Screw	CL3536	FDA UDI	Class II	Active
3.5mm x 24mm Cannulated Headed Screw	CH3524	FDA UDI	Class II	Active
3.5mm x 24mm Cortex Screw	SC3524	FDA UDI	Class II	Active
Side Plate, PH	5712-1	FDA UDI	Class II	Active
2.7mm x 18mm Cannulated Tapered-Head Screw	FS18	FDA UDI	Class II	Active
2.7mm x 16mm Cannulated Tapered-Head Screw	FS16	FDA UDI	Class II	Active
3.5mm x 48mm Locking Screw	SL3548	FDA UDI	Class II	Active
3.5mm x 50mm Cannulated Locking Screw	CL3550	FDA UDI	Class II	Active
2.7mm x 22mm Cannulated Headed Screw	BH2722	FDA UDI	Class II	Active

Conventus Orthopaedics

What Conventus Orthopaedics makes

Frequently asked questions

Information

Catalogue (147)

Related Companies

Authorised Representatives

Importers

Notified Bodies

Authorities