CoLink Plating System, Fracture and Correction System, CoLink Mini Plating Syst…
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K193543 FDA 510(k)
- FDA Product Code
- HRS FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3030 FDA 510(k)
- Regulation Number
- 888.3030 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The CoLink Plating Systems are orthopedic fixation devices classified as Plates, Orthopedic, Metallic (FDA Product Code: HRS). These systems include locking and non-locking plates designed for the stabilization and fixation of fractures, osteotomies, joint fusions, and reconstructions in the small bones of the hand, wrist, foot, and ankle. The CoLink Afx Plating System specifically targets traumatic fractures and osteotomies of the ankle, while the Mini and View variants are tailored for smaller bones and enhanced visualization during procedures.
These systems are supplied sterile and intended for single-use, though reusable components may exist per manufacturer specifications. The CoLink Afx Ankle Fracture Plating System comprises five plate families, each tailored to specific fracture patterns. The devices are regulated under FDA 510(k) clearance (K193543) and MDR, with the CoLink Mini and View systems falling under the same orthopedic advisory committee classification. Storage and handling follow standard sterile orthopedic implant protocols.
Frequently asked questions
What types of fractures or bone conditions is the CoLink Plating System specifically designed to address in the hand, wrist, foot, and ankle areas?
The CoLink Plating Systems are engineered for stabilizing fractures, osteotomies (surgical bone cuts), joint fusions, and reconstructions in small bones. The CoLink Afx Plating System is specialized for traumatic fractures and osteotomies of the ankle, while the Mini and View variants focus on smaller bones and offer improved visualization during procedures, making them ideal for delicate or complex cases.
Are the CoLink Plating Systems intended for single-use, or can components be reused after sterilization?
The CoLink Plating Systems are sterile upon supply and explicitly intended for single-use as per manufacturer guidelines. While some reusable components *may* exist (as noted in the description), the primary design and regulatory classification assume single-use for orthopedic fixation in clinical settings.
How do the CoLink Mini and View Plating Systems differ from the standard CoLink Plating System in terms of application?
The CoLink Mini Plating System is tailored for smaller bones, offering compact plate designs for precise fixation. The CoLink View Plating System enhances visualization during surgery, which is particularly useful for intricate procedures where clear sightlines are critical. Both variants retain the same core function—stabilizing fractures and osteotomies—but are optimized for specific anatomical or procedural needs.
What regulatory pathways have the CoLink Plating Systems undergone, and how does this affect their use in clinical settings?
The CoLink Plating Systems have received FDA 510(k) clearance (K193543) and comply with MDR (Medical Device Regulation) standards. This clearance confirms they are deemed substantially equivalent to legally marketed predecessors, ensuring they meet safety and effectiveness requirements for orthopedic fixation. Clinicians can rely on these pathways for evidence of regulatory scrutiny before use.
How should the CoLink Afx Ankle Fracture Plating System be stored, and what distinguishes its five plate families?
Storage follows standard sterile orthopedic implant protocols, as implied by the manufacturer’s specifications. The CoLink Afx Ankle Fracture Plating System includes five plate families, each designed to address specific ankle fracture patterns (e.g., lateral malleolus, medial malleolus, or pilon fractures). The modular design allows surgeons to select plates based on the anatomical complexity and stabilization needs of the injury.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: CoLink Plating Systems | CONMED, CoLink Afx Ankle Fracture Plating System | CONMED, CoLink Plating System, Fracture and Correction System, CoLink Mini ..., CoLink_Mini_ST_103019r - admin.conmed.com
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K193543 | Class II | Active |
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Manufacturer
- Manufacturer
- In2Bones USA, LLC
Sources (2)
- FDA 510(k) K193543 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026