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ORTHO SOLUTIONS HOLDINGS LIMITED

Last updated May 24, 2026

What ORTHO SOLUTIONS HOLDINGS LIMITED makes

Ortho Solutions Holdings Limited manufactures orthopaedic fixation devices, including non-bioabsorbable bone screws (both sterile and non-sterile), fixation plates, bone staples, bone wires, and reusable instrument trays. Their portfolio also covers single-use surgical tools like oscillating saw blades and specialized systems for ankle fusion and osteosynthesis, such as the Oxford Ankle Fusion Nail (AFN) System and the Volition™ Plating System.

The company’s devices are regulated under FDA’s 510(k) pathway as Class I and Class II medical devices, with relevant products listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Ortho Solutions Holdings Limited manufacture?

Ortho Solutions Holdings Limited specializes in orthopaedic fixation devices. Their portfolio includes non-bioabsorbable bone screws (available in sterile and non-sterile versions), fixation plates, bone staples, bone wires, and reusable instrument trays. They also produce single-use surgical tools like oscillating saw blades, as well as specialized systems such as the Oxford Ankle Fusion Nail (AFN) System and the Volition™ Plating System for orthopaedic procedures.

Where is Ortho Solutions Holdings Limited based?

The company is headquartered in the United States. This location influences its regulatory compliance, particularly under the FDA’s jurisdiction for medical device authorization.

Which regulatory registries list Ortho Solutions Holdings Limited’s devices?

Ortho Solutions Holdings Limited’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for authorized products, including orthopaedic fixation devices like screws, plates, and specialized systems such as the Oxford Ankle Fusion Nail (AFN) System.

How are Ortho Solutions Holdings Limited’s devices classified under FDA regulations?

Ortho Solutions Holdings Limited’s devices fall under FDA’s Class I and Class II classifications. Class I devices generally pose minimal risk and may require less regulatory scrutiny, while Class II devices—such as certain fixation plates or specialized systems—require premarket notification (510(k)) to demonstrate substantial equivalence to a predicate device. Classification depends on factors like intended use, risk, and procedural complexity.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: US
Address: —
Website: orthosol.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +441621843599
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 218648211

Catalogue (2340)

Page 2 of 47

Device	Model / Reference	Registries	Class	Status
OrthoSolutions 'System26' Bone Screws	OS923075-NS	FDA UDI	Class II	Active
Ortho Solutions Extremity Fixation Implants For Osteosysnthesis	OS361006	FDA UDI	Class II	Active
Volition™ Plating System	OS712718-NS	FDA UDI	Class II	Active
Ortho Solutions Trauma Implants For Osteosynthesis	OS309090	FDA UDI	Class II	Active
Volition™ Plating System	OS703544-NS	FDA UDI	Class II	Active
Volition™ Plating System	OS713548-NS	FDA UDI	Class II	Active
Ortho Solutions Sterile Drill Bits	OS319052	FDA UDI	Class I	Active
Ortho Solutions Ultos Plating System	OS422512	FDA UDI	Class II	Active
Ortho Solutions Trauma Implants For Osteosynthesis	OS246530	FDA UDI	Class II	Active
Ortho Solutions Sterile Drill Bits	OSD-5103	FDA UDI	Class I	Active
Volition™ Plating System	OS721013-NS	FDA UDI	Class I	Active
Ortho Solutions Extremity Fixation Implants For Osteosysnthesis	OS326840	FDA UDI	Class II	Active
Volition Plating System	OS740032-NS	FDA UDI	Class II	Active
OrthoSolutions 'System26' Bone Screws	OS906022-NS	FDA UDI	Class II	Active
Ortho Solutions Trauma Plates For Osteosysnthesis	OS420510	FDA UDI	Class II	Active
Ortho Solutions Trauma Plates For Osteosysnthesis	OS470008	FDA UDI	Class II	Active
OrthoSolutions 'System26' Bone Screws	OS912036-NS	FDA UDI	Class II	Active
Ortho Solutions Sterile Drill Bits	OS200325	FDA UDI	Class I	Active
OrthoSolutions 'System26' Bone Screws	OS900054-NS	FDA UDI	Class I	Active
Ortho Solutions Ultos Plating System	OS326945-NS	FDA UDI	Class II	Active
Ortho Solutions Sterile Drill Bits	OS319050	FDA UDI	Class I	Active
OrthoSolutions 'System26' Bone Screws	OS922035-NS	FDA UDI	Class II	Active
OrthoSolutions 'System26' Bone Screws	OS916055-NS	FDA UDI	Class II	Unknown
OrthoSolutions 'System26' Bone Screws	OS924085-NS	FDA UDI	Class II	Active
OrthoSolutions 'System26' Bone Screws	OS922105-NS	FDA UDI	Class II	Unknown
OrthoSolutions 'System26' Bone Screws	OS920080-NS	FDA UDI	Class II	Active
Volition Plating System	OS732024L-NS	FDA UDI	Class II	Active
Ortho Solutions Extremity Fixation Implants For Osteosysnthesis	OS310017	FDA UDI	Class II	Active
Ortho Solutions Sterile Drill Bits	OSS-3115	FDA UDI	Class I	Active
Ortho Solutions Trauma Plates For Osteosysnthesis	OS467055	FDA UDI	Class II	Active
Ortho Solutions Extremity Fixation Implants For Osteosysnthesis	OS310706	FDA UDI	Class II	Active
Ortho Solutions Trauma Plates For Osteosysnthesis	OS435024	FDA UDI	Class II	Active
Ortho Solutions Extremity Fixation Implants For Osteosysnthesis	OS312000	FDA UDI	Class II	Active
Ortho Solutions Trauma Implants For Osteosynthesis	OS309095	FDA UDI	Class II	Active
COGNiTiON™ Staple System	OS380035-NS	FDA UDI	Class I	Active
Ortho Solutions Trauma Plates For Osteosysnthesis	OS415008	FDA UDI	Class II	Active
Ortho Solutions Ultos Plating System	OS423019-NS	FDA UDI	Class II	Active
Volition Plating System	OS720015-NS	FDA UDI	Class I	Active
Volition™ Plating System	OS722116-NS	FDA UDI	Class II	Active
OrthoSolutions 'System26' Bone Screws	OS914055-NS	FDA UDI	Class II	Active
OrthoSolutions 'System26' Bone Screws	OS922095-NS	FDA UDI	Class II	Unknown
Volition Plating System	OS741032-NS	FDA UDI	Class II	Active
Volition Plating System	OS741024-NS	FDA UDI	Class II	Active
OrthoSolutions 'System26' Bone Screws	OS908040-NS	FDA UDI	Class II	Active
Volition™ Plating System	OS720003-NS	FDA UDI	Class I	Active
OrthoSolutions 'System26' Bone Screws	OS921085-NS	FDA UDI	Class II	Active
Volition Plating System	OS733021L-NS	FDA UDI	Class I	Active
Volition Plating System	OS733100A-NS	FDA UDI	Class II	Active
Ortho Solutions Ultos Plating System	OS422825-NS	FDA UDI	Class II	Active
Ortho Solutions Ultos Plating System	OS421514-NS	FDA UDI	Class II	Active

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