TriMed Ankle Fixation System
FDA 510(k)Class II (US FDA 510(k))
by Trimed, INC.
Identifiers
- 510(k) Number
- K243999 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 TriMed Ankle Fixation System is an orthopedic device classified as a Fracture Fixation Device for Lower Extremity (per FDA nomenclature). It is designed to stabilize and support ankle fractures through internal fixation, utilizing components such as hooks, plates, sleds, and screws to restore anatomical alignment and promote proper healing in periarticular fractures of the ankle and foot.
This system is intended for surgical use in orthopedic settings and is supplied as a sterile, single-use device. It is approved under FDA 510K clearance (K243999) as substantially equivalent to predicate devices in orthopedic fracture fixation. Components are engineered for compatibility with standard orthopedic instrumentation and are regulated under the Orthopedic (OR) Advisory Committee classification. Storage and handling must adhere to sterile medical device protocols.
Frequently asked questions
What types of ankle fractures is the TriMed Ankle Fixation System specifically designed to treat?
The TriMed Ankle Fixation System is designed to stabilize and support periarticular fractures of the ankle and foot, helping restore anatomical alignment for proper healing. It uses components like hooks, plates, sleds, and screws to internally fix fractures, ensuring stability during the recovery process.
Is the TriMed Ankle Fixation System reusable, or is it intended for single-use only?
The TriMed Ankle Fixation System is explicitly supplied as a sterile, single-use device. This ensures patient safety and compliance with sterile medical device protocols, preventing cross-contamination between procedures.
How should the TriMed Ankle Fixation System be stored to maintain its sterility?
Since it is a sterile, single-use device, storage must follow strict sterile medical device protocols to preserve integrity. The packaging should remain unopened until immediate preoperative use, and it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures.
What makes the TriMed Ankle Fixation System compatible with standard orthopedic tools?
The system’s components are engineered for compatibility with standard orthopedic instrumentation, meaning it can be used with widely available surgical tools for ankle fixation. This ensures ease of integration into existing operating room workflows and reduces the need for specialized equipment.
How was the TriMed Ankle Fixation System approved by the FDA, and what does that mean for its use?
The device received FDA 510(k) clearance (K243999) under the Traditional review pathway, with a decision of Substantially Equivalent (SESE) to predicate fracture fixation devices. This means it meets FDA standards for safety and effectiveness as determined by the Orthopedic (OR) Advisory Committee, allowing its use in clinical settings for the intended orthopedic purpose.
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: Ankle Fixation Systems - Foot & Ankle Implants - TriMed Inc., Lower Extremity - Ankle & Foot Fracture Fixation - TriMed Inc., Ankle Fixation Systems - Foot & Ankle Implants - TriMed Inc., Ankle Fixation System - TriMed Inc., Ankle Fixation - Ortho Providers
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K243999 | Class II | Active |
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Manufacturer
- Manufacturer
- Trimed, INC.
Sources (1)
- FDA 510(k) K243999 24 fields · synced Sep 19, 2026