Is this your brand? Sign in to claim ownership.

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 5 of 47

Device	Model / Reference	Registries	Class	Status
Ortho Solutions Trauma Implants For Osteosynthesis	OS212125	FDA UDI	Class II	Active
Ortho Solutions Trauma Plates For Osteosysnthesis	OS445056	FDA UDI	Class II	Active
Volition™ Plating System	OS730012-NS	FDA UDI	Class II	Active
Ortho Solutions Trauma Implants For Osteosynthesis	OS323012	FDA UDI	Class II	Active
Volition™ Plating System	OS721027-NS	FDA UDI	Class II	Active
Ortho Solutions Ultos Plating System	OS421408-NS	FDA UDI	Class II	Active
OrthoSolutions 'System26' Bone Screws	OS920045-NS	FDA UDI	Class II	Active
Ortho Solutions Trauma Implants For Osteosynthesis	OS314100	FDA UDI	Class II	Active
Ortho Solutions Ultos Plating System	OS422518	FDA UDI	Class II	Active
Ortho Solutions Extremity Fixation Implants For Osteosysnthesis	OS327406	FDA UDI	Class II	Active
Ortho Solutions Trauma Plates For Osteosysnthesis	OS440026	FDA UDI	Class II	Active
Ortho Solutions Extremity Fixation Implants For Osteosysnthesis	OS312040	FDA UDI	Class II	Active
Volition™ Plating System	OS703542-NS	FDA UDI	Class II	Active
Volition™ Plating System	OS712726-NS	FDA UDI	Class II	Active
Oxford Ankle Fusion Nail(afn) System	OS333023	FDA UDI	Class II	Active
Ortho Solutions Trauma Plates For Osteosysnthesis	OS415018	FDA UDI	Class II	Active
OrthoSolutions 'System26' Bone Screws	OS905016-NS	FDA UDI	Class II	Active
Volition Plating System	OS733022L-NS	FDA UDI	Class I	Active
OrthoSolutions 'System26' Bone Screws	OS912070-NS	FDA UDI	Class II	Active
Ortho Solutions Ultos Plating System	OS421824-NS	FDA UDI	Class II	Active
Ortho Solutions Extremity Fixation Implants For Osteosysnthesis	OS327510	FDA UDI	Class II	Active
OrthoSolutions 'System26' Bone Screws	OS919040-NS	FDA UDI	Class II	Unknown
OrthoSolutions 'System26' Bone Screws	OS914120-NS	FDA UDI	Class II	Unknown
Oxford Ankle Fusion Nail(afn) System	OS333006	FDA UDI	Class II	Active
OrthoSolutions 'System26' Bone Screws	OS918050-NS	FDA UDI	Class II	Active
Ortho Solutions Trauma Plates For Osteosysnthesis	OS441022	FDA UDI	Class II	Active
Volition Plating System	OS732021L-NS	FDA UDI	Class II	Active
Ortho Solutions Extremity Fixation Implants For Osteosysnthesis	OS361279	FDA UDI	Class II	Active
Ortho Solutions Extremity Fixation Implants For Osteosysnthesis	OS310510	FDA UDI	Class II	Active
OrthoSolutions 'System26' Bone Screws	OS922090-NS	FDA UDI	Class II	Unknown
Ortho Solutions Extremity Fixation Implants for Osteosysnthesis	OS325001	FDA UDI	Class II	Active
OrthoSolutions 'System26' Bone Screws	OS920105-NS	FDA UDI	Class II	Active
OrthoSolutions 'System26' Bone Screws	OS904030-NS	FDA UDI	Class II	Active
Volition Plating System	OS740214-NS	FDA UDI	Class II	Active
OrthoSolutions 'System26' Bone Screws	OS911046-NS	FDA UDI	Class II	Active
Ortho Solutions Extremity Fixation Implants For Osteosysnthesis	OS320051	FDA UDI	Class I	Active
Volition Plating System	OS734023-NS	FDA UDI	Class I	Active
Ortho Solutions Trauma Implants For Osteosynthesis	OS315060	FDA UDI	Class II	Active
OrthoSolutions 'System26' Bone Screws	OS916105-NS	FDA UDI	Class II	Active
Ortho Solutions Trauma Plates For Osteosysnthesis	OS435512	FDA UDI	Class II	Active
OrthoSolutions 'System26' Bone Screws	OS909010-NS	FDA UDI	Class II	Active
Volition Plating System	OS740026-NS	FDA UDI	Class II	Active
Volition™ Plating System	OS713546-NS	FDA UDI	Class II	Active
Ortho Solutions Succession Afn System	OS355040-S	FDA UDI	Class II	Active
Ortho Solutions Succession Afn System	OS356100-S	FDA UDI	Class II	Active
OrthoSolutions 'System26' Bone Screws	OS909020-NS	FDA UDI	Class II	Active
OrthoSolutions 'System26' Bone Screws	OS913115-NS	FDA UDI	Class II	Unknown
Ortho Solutions Ultos Plating System	OS422516-NS	FDA UDI	Class II	Active
OrthoSolutions 'System26' Bone Screws	OS921105-NS	FDA UDI	Class II	Active
Ortho Solutions Trauma Implants For Osteosynthesis	OS323023	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.