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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 1 of 47

Device	Model / Reference	Registries	Class	Status
Ortho Solutions Sterile Drill Bits	OSS-860	FDA UDI	Class I	Active
Ortho Solutions Succession Afn System	OS353500C-NS	FDA UDI	Class I	Active
Oxford Ankle Fusion Nail(afn) System	OS333002	FDA UDI	Class II	Active
Volition™ Plating System	OS704020-NS	FDA UDI	Class II	Active
Volition™ Plating System	OS731042-NS	FDA UDI	Class II	Active
Oxford Ankle Fusion Nail(afn) System	OS333013	FDA UDI	Class II	Active
OrthoSolutions 'System26' Bone Screws	OS914110-NS	FDA UDI	Class II	Unknown
Ortho Solutions Sterile Drill Bits	OSS-882	FDA UDI	Class I	Active
Ortho Solutions Ultos Plating System	OS328009-NS	FDA UDI	Class II	Unknown
OrthoSolutions 'System26' Bone Screws	OS924095-NS	FDA UDI	Class II	Active
Ortho Solutions Ultos Plating System	OS200020L	FDA UDI	Class II	Active
Ortho Solutions Trauma Plates For Osteosysnthesis	OS465040	FDA UDI	Class II	Active
Ortho Solutions Sterile Drill Bits	OS200128	FDA UDI	Class I	Active
OrthoSolutions 'System26' Bone Screws	OS909024-NS	FDA UDI	Class II	Active
OrthoSolutions 'System26' Bone Screws	OS901012-NS	FDA UDI	Class II	Active
Ortho Solutions Trauma Plates For Osteosysnthesis	OS420512	FDA UDI	Class II	Active
OrthoSolutions 'System26' Bone Screws	OS310015-NS	FDA UDI	Class II	Active
Volition Plating System	OS733201-NS	FDA UDI	Class II	Active
Ortho Solutions Extremity Fixation Implants For Osteosysnthesis	OS306326	FDA UDI	Class II	Active
Ortho Solutions Trauma Plates For Osteosysnthesis	OS445546	FDA UDI	Class II	Active
OrthoSolutions 'System26' Bone Screws	OS900063B-NS	FDA UDI	Class I	Active
OrthoSolutions 'System26' Bone Screws	OS916115-NS	FDA UDI	Class II	Active
Volition Plating System	OS734012-NS	FDA UDI	Class I	Active
Volition Plating System	OS733301-NS	FDA UDI	Class II	Active
Volition™ Plating System	OS713512-NS	FDA UDI	Class II	Active
Ortho Solutions Ultos Plating System	OS422630-NS	FDA UDI	Class II	Active
Volition™ Plating System	OS714024-NS	FDA UDI	Class II	Active
OrthoSolutions 'System26' Bone Screws	OS900001-NS	FDA UDI	Class I	Active
OrthoSolutions 'System26' Bone Screws	OS920070-NS	FDA UDI	Class II	Unknown
OrthoSolutions 'System26' Bone Screws	OS919105-NS	FDA UDI	Class II	Active
OrthoSolutions 'System26' Bone Screws	OS900001C-NS	FDA UDI	Class I	Active
OrthoSolutions 'System26' Bone Screws	OS917080-NS	FDA UDI	Class II	Active
Ortho Solutions Trauma Plates For Osteosysnthesis	OS400110	FDA UDI	Class II	Active
Ortho Solutions Trauma Plates For Osteosysnthesis	OS441055	FDA UDI	Class II	Active
Ortho Solutions Ultos Plating System	OS421004L-NS	FDA UDI	Class II	Active
Ortho Solutions Extremity Fixation Implants For Osteosysnthesis	OS361007	FDA UDI	Class II	Active
OrthoSolutions 'System26' Bone Screws	OS917085-NS	FDA UDI	Class II	Active
Ortho Solutions Ultos Plating System	OS422628-NS	FDA UDI	Class II	Active
Ortho Solutions Trauma Plates For Osteosysnthesis	OS435110	FDA UDI	Class II	Active
Ortho Solutions Trauma Implants For Osteosynthesis	OS309040	FDA UDI	Class II	Active
Ortho Solutions Trauma Plates For Osteosysnthesis	OS440040	FDA UDI	Class II	Active
OrthoSolutions 'System26' Bone Screws	OS918110-NS	FDA UDI	Class II	Active
OrthoSolutions 'System26' Bone Screws	OS917090-NS	FDA UDI	Class II	Active
Ortho Solutions Extremity Fixation Implants For Osteosysnthesis	OS306310	FDA UDI	Class II	Active
Ortho Solutions Extremity Fixation Implants For Osteosysnthesis	OS327407	FDA UDI	Class II	Active
Volition™ Plating System	OS702722-NS	FDA UDI	Class II	Active
Ortho Solutions Trauma Plates For Osteosysnthesis	OS465105	FDA UDI	Class II	Active
Ortho Solutions Extremity Fixation Implants For Osteosysnthesis	OS306216	FDA UDI	Class II	Active
Ortho Solutions Trauma Plates For Osteosysnthesis	OS435016	FDA UDI	Class II	Active
OrthoSolutions 'System26' Bone Screws	OS903024-NS	FDA UDI	Class II	Active

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