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510(k) Data Aggregation
K Number
K250622Device Name
Succession AFN System
Manufacturer
Date Cleared
2025-08-07
(160 days)
Product Code
Regulation Number
888.3020Why did this record match?
Applicant Name (Manufacturer) :
Ortho Solutions UK Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K240212Device Name
COGNiTiON Staple System
Manufacturer
Date Cleared
2024-02-23
(29 days)
Product Code
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
Ortho Solutions UK Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Ortho Solutions COGNITiON™ Staple System is indicated for hand and foot bone fragments, osteotomy, fixation and joint arthrodesis. The COGNiTiON™ Staple System is not intended for spinal use.
Device Description
The COGNITION Staple System is comprised of a set of implantable metallic (Superelastic NiTi Alloy per ASTM F2063) staples and accessory instrumentation. The system consists of a series of two and four-leg staples of various bridge and leg lengths. Each staple is provided to the user in a relaxed state with the staple legs in a converging position. During the staple insertion step, the provided staple driver is used to splay the staple legs, allowing for implantation across the fracture, fusion, or osteotomy site. The staple legs then have the inherent propensity to converge due to the superelastic nature of the NiTi material. This stability is intended to allow for bone healing to occur.
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K Number
K210658Device Name
Volition Plating System
Manufacturer
Date Cleared
2021-04-13
(40 days)
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
Ortho Solutions UK Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Volition Plating System is indication and fixation of fractures or osteotomies, revision procedures, joint fusion, and reconstruction of small bones of the feet and ankles, including the toes, talus, and calcaneus; the distal fibula and tibia; as well as the fingers, hands, and wrists.
In addition, the non-locking screws and washers are in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device.
Device Description
The Volition Plating System is a set of implantable metallic (Titanium Alloy) bone plates consisting of a series of tubular plates of varying lengths as well as anatomically contoured plates. The Volition Plating System plates are provided with locking and non-locking in Ø2.7mm, Ø3.5mm, & Ø4.0mm previously cleared under K202764. All implants are made from Titanium Alloy (Ti-6AL-4V ELI) per ASTM F136 and are provided non-sterile.
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K Number
K202764Device Name
Ortho Solutions Plating System
Manufacturer
Date Cleared
2020-11-20
(60 days)
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
Ortho Solutions UK Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Ortho Solutions Plating System is indicated for use in stabilization of fractures or osteotomies, revision procedures, joint fusion, and reconstruction of small bones of the feet and ankles, including the toes, talus, and calcaneus; the distal fibula and tibia; as well as the fingers, hands, and wrists.
In addition, the non-locking screws and washers are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device.
Device Description
The Ortho Solutions Plating System is a set of implantable metallic (Titanium Alloy) bone plates, locking and non-locking screws of various lengths. The system consists of a series of tubular plates of varying lengths as well as anatomically contoured plates. Locking and non-locking screws are provided in Ø2.7mm, Ø3.5mm, & Ø4.0mm in various lengths and are compatible with all plates. All implants are made from Titanium Alloy (Ti-6AL-4V ELI) per ASTM F136 and are provided non-sterile.
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