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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 4 of 47

Device	Model / Reference	Registries	Class	Status
Ortho Solutions Trauma Implants For Osteosynthesis	OS316115	FDA UDI	Class II	Active
OrthoSolutions 'System26' Bone Screws	OS920105-NS	FDA UDI	Class II	Unknown
Ortho Solutions Ultos Plating System	OS421814-NS	FDA UDI	Class II	Active
Ortho Solutions Sterile Drill Bits	OSS-3125	FDA UDI	Class I	Active
COGNiTiON™ Staple System	OS380021-NS	FDA UDI	Class I	Active
Ortho Solutions Trauma Plates For Osteosysnthesis	OS427036	FDA UDI	Class II	Active
Ortho Solutions Succession Afn System	OS351119-S	FDA UDI	Class II	Active
Volition™ Plating System	OS703560-NS	FDA UDI	Class II	Active
Ortho Solutions Ultos Plating System	OS422508	FDA UDI	Class II	Active
Oxford Ankle Fusion Nail(afn) System	OS331180N	FDA UDI	Class II	Active
Ortho Solutions Trauma Implants For Osteosynthesis	OS100005S	FDA UDI	Class II	Active
Ortho Solutions Trauma Implants For Osteosynthesis	OS315040	FDA UDI	Class II	Active
Ortho Solutions Trauma Implants For Osteosynthesis	OS221510	FDA UDI	Class II	Active
Ortho Solutions Extremity Fixation Implants For Osteosysnthesis	OS326712	FDA UDI	Class II	Active
OrthoSolutions 'System26' Bone Screws	OS919075-NS	FDA UDI	Class II	Unknown
Ortho Solutions Extremity Fixation Implants For Osteosysnthesis	OS328002	FDA UDI	Class II	Active
Ortho Solutions Extremity Fixation Implants For Osteosysnthesis	OS327404	FDA UDI	Class II	Active
Volition™ Plating System	OS731011L-NS	FDA UDI	Class II	Active
OrthoSolutions 'System26' Bone Screws	OS916090-NS	FDA UDI	Class II	Unknown
OrthoSolutions 'System26' Bone Screws	OS906012-NS	FDA UDI	Class II	Active
OrthoSolutions 'System26' Bone Screws	OS924090-NS	FDA UDI	Class II	Active
Ortho Solutions Sterile Drill Bits	OS310101S	FDA UDI	Class I	Active
Ortho Solutions Extremity Fixation Implants For Osteosysnthesis	OS327612	FDA UDI	Class II	Active
OrthoSolutions 'System26' Bone Screws	OS914050-NS	FDA UDI	Class II	Active
OrthoSolutions 'System26' Bone Screws	OS909065-NS	FDA UDI	Class II	Active
Volition Plating System	OS741028-NS	FDA UDI	Class II	Active
OrthoSolutions 'System26' Bone Screws	OS900092-NS	FDA UDI	Class I	Active
OrthoSolutions 'System26' Bone Screws	OS914095-NS	FDA UDI	Class II	Unknown
Ortho Solutions Trauma Plates For Osteosysnthesis	OS427008	FDA UDI	Class II	Active
OrthoSolutions 'System26' Bone Screws	OS917120-NS	FDA UDI	Class II	Active
OrthoSolutions 'System26' Bone Screws	OS922095-NS	FDA UDI	Class II	Active
Ortho Solutions Extremity Fixation Implants For Osteosysnthesis	OS326735	FDA UDI	Class II	Active
Ortho Solutions Trauma Plates For Osteosysnthesis	OS465035	FDA UDI	Class II	Active
Ortho Solutions Sterile Drill Bits	OSS-840	FDA UDI	Class I	Active
Ortho Solutions Trauma Plates For Osteosysnthesis	OS445544	FDA UDI	Class II	Active
OrthoSolutions 'System26' Bone Screws	OS913070-NS	FDA UDI	Class II	Unknown
Ortho Solutions Trauma Implants For Osteosynthesis	OS210100	EUDAMEDFDA UDI	Class II	Active
Ortho Solutions Extremity Fixation Implants For Osteosysnthesis	OS327204	FDA UDI	Class II	Active
Ortho Solutions Trauma Implants For Osteosynthesis	OS231240	FDA UDI	Class II	Active
Ortho Solutions Trauma Plates For Osteosysnthesis	OS481005	FDA UDI	Class II	Active
Ortho Solutions Trauma Implants For Osteosynthesis	OS321040	FDA UDI	Class II	Active
Ortho Solutions Extremity Fixation Implants For Osteosysnthesis	OS326304	FDA UDI	Class II	Active
Volition Plating System	OS741300-NS	FDA UDI	Class I	Active
OrthoSolutions 'System26' Bone Screws	OS917120-NS	FDA UDI	Class II	Unknown
Ortho Solutions Ultos Plating System	OS422616-NS	FDA UDI	Class II	Active
Volition Plating System	OS733300-NS	FDA UDI	Class II	Active
Volition Plating System	OS734011-NS	FDA UDI	Class I	Active
OrthoSolutions 'System26' Bone Screws	OS909040-NS	FDA UDI	Class II	Active
Ortho Solutions Ultos Plating System	OS421845	FDA UDI	Class II	Active
Volition™ Plating System	OS713530-NS	FDA UDI	Class II	Active

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