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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 3 of 47

Device	Model / Reference	Registries	Class	Status
Oxford Ankle Fusion Nail(afn) System	OS330024	FDA UDI	Class II	Active
Ortho Solutions Extremity Fixation Implants For Osteosysnthesis	OS326850	FDA UDI	Class II	Active
OrthoSolutions 'System26' Bone Screws	OS901010-NS	FDA UDI	Class II	Active
Ortho Solutions Ultos/Volition Plating System	OS328001-NS	FDA UDI	Class I	Active
Ortho Solutions Extremity Fixation Implants For Osteosysnthesis	OS361602	FDA UDI	Class II	Active
Ortho Solutions Extremity Fixation Implants For Osteosysnthesis	OS326130	FDA UDI	Class II	Active
Ortho Solutions Trauma Plates For Osteosysnthesis	OS480003	FDA UDI	Class II	Active
Volition™ Plating System	OS703530-NS	FDA UDI	Class II	Active
Ortho Solutions Ultos Plating System	OS422528-NS	FDA UDI	Class II	Active
Ortho Solutions Sterile Drill Bits	OSS-818	FDA UDI	Class I	Active
OrthoSolutions 'System26' Bone Screws	OS913090-NS	FDA UDI	Class II	Unknown
OrthoSolutions 'System26' Bone Screws	OS924070-NS	FDA UDI	Class II	Active
Ortho Solutions Extremity Fixation Implants For Osteosysnthesis	OS327405	FDA UDI	Class II	Active
Ortho Solutions Trauma Plates For Osteosysnthesis	OS445058	FDA UDI	Class II	Active
Ortho Solutions Extremity Fixation Implants For Osteosysnthesis	OS310013	FDA UDI	Class II	Active
OrthoSolutions 'System26' Bone Screws	OS916110-NS	FDA UDI	Class II	Unknown
Volition™ Plating System	OS722027-NS	FDA UDI	Class I	Active
OrthoSolutions 'System26' Bone Screws	OS912032-NS	FDA UDI	Class II	Active
Ortho Solutions Trauma Implants For Osteosynthesis	OS316050	FDA UDI	Class II	Active
Ortho Solutions Trauma Implants For Osteosynthesis	OS292223	FDA UDI	Class II	Active
Ortho Solutions Trauma Plates For Osteosysnthesis	OS427030	FDA UDI	Class II	Active
Ortho Solutions Ultos Plating System	OS328001-NS	FDA UDI	Class II	Active
Ortho Solutions Extremity Fixation Implants For Osteosysnthesis	OS326512	FDA UDI	Class II	Active
Ortho Solutions Trauma Plates For Osteosysnthesis	OS471002	FDA UDI	Class II	Active
Volition™ Plating System	OS730008-NS	FDA UDI	Class II	Active
OrthoSolutions 'System26' Bone Screws	OS918075-NS	FDA UDI	Class II	Active
Oxford Ankle Fusion Nail(afn) System	OS330055	FDA UDI	Class II	Active
Ortho Solutions Ultos Plating System	OS326928	FDA UDI	Class II	Active
Ortho Solutions Trauma Plates For Osteosysnthesis	OS435536	FDA UDI	Class II	Active
Ortho Solutions Extremity Fixation Implants For Osteosysnthesis	OS327530	FDA UDI	Class II	Active
OrthoSolutions 'System26' Bone Screws	OS907038-NS	FDA UDI	Class II	Active
Oxford Ankle Fusion Nail(afn) System	OS333506	FDA UDI	Class II	Active
Ortho Solutions Succession Afn System	OS355030-S	FDA UDI	Class II	Active
Volition™ Plating System	OS712716-NS	FDA UDI	Class II	Active
Ortho Solutions Trauma Plates For Osteosysnthesis	OS445528	FDA UDI	Class II	Active
Ortho Solutions Trauma Plates For Osteosysnthesis	OS467020	FDA UDI	Class II	Active
OrthoSolutions 'System26' Bone Screws	OS911055-NS	FDA UDI	Class II	Active
Ortho Solutions Trauma Implants For Osteosynthesis	OS233025	FDA UDI	Class II	Active
OrthoSolutions 'System26' Bone Screws	OS914080-NS	FDA UDI	Class II	Unknown
Ortho Solutions Trauma Plates For Osteosysnthesis	OS435518	FDA UDI	Class II	Active
Ortho Solutions Extremity Fixation Implants For Osteosysnthesis	OS362083	FDA UDI	Class II	Active
Ortho Solutions Extremity Fixation Implants For Osteosysnthesis	OS327120	FDA UDI	Class II	Active
Ortho Solutions Extremity Fixation Implants For Osteosysnthesis	OS312060	FDA UDI	Class II	Active
Volition™ Plating System	OS714048-NS	FDA UDI	Class II	Active
OrthoSolutions 'System26' Bone Screws	OS908030-NS	FDA UDI	Class II	Active
OrthoSolutions 'System26' Bone Screws	OS922120-NS	FDA UDI	Class II	Active
Ortho Solutions Succession Afn System	OS355024-S	FDA UDI	Class II	Active
OrthoSolutions 'System26' Bone Screws	OS909032-NS	FDA UDI	Class II	Active
OrthoSolutions 'System26' Bone Screws	OS920075-NS	FDA UDI	Class II	Unknown
OrthoSolutions 'System26' Bone Screws	OS915050-NS	FDA UDI	Class II	Active

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