Syntec-Taichung Non-Sterile DHS/DCS Plate System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K983873 FDA 510(k)
- FDA Product Code
- KTT 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 Syntec-Taichung Non-Sterile DHS/DCS Plate System is a fixation device classified as a Nail/Blade/Plate Combination, Multiple Component (Product Code KTT). It is designed for internal fixation of proximal femur fractures, including femoral neck, trochanteric, pertrochanteric, and intertrochanteric zones, providing stable alignment and support during bone healing.
Supplied non-sterile, this system is intended for use in orthopedic surgical settings. It is regulated under FDA 510(k) clearance (K983873) and falls under Class II – Special Controls. The device is manufactured by Syntec Scientific Corp. and must be sterilized prior to use in clinical procedures. No additional regulatory approvals beyond the stated 510(k) clearance are referenced in the specifications.
Frequently asked questions
What types of proximal femur fractures is this plate system designed to address, and how does it support bone healing?
The Syntec-Taichung Non-Sterile DHS/DCS Plate System is specifically designed for internal fixation of fractures in the proximal femur, including the femoral neck, trochanteric, pertrochanteric, and intertrochanteric zones. It provides stable alignment and support to the bone fragments, ensuring proper positioning during the healing process to promote effective bone union.
Is this device supplied sterile, and what preparation is required before clinical use?
No, this device is supplied non-sterile and must be sterilized prior to use in surgical procedures. The manufacturer does not specify the sterilization method, so facilities should follow their standard protocols for sterilizing orthopedic fixation devices.
How is this device categorized under FDA regulations, and what does that mean for its use?
The Syntec-Taichung DHS/DCS Plate System is classified as a Class II – Special Controls device under the FDA’s Product Code KTT (Nail/Blade/Plate Combination, Multiple Component). It holds a 510(k) clearance (K983873) and is deemed substantially equivalent to a predicate device, meaning it meets FDA requirements for safety and effectiveness as determined through the traditional 510(k) review process.
What should clinicians consider when selecting sizes or models for this fixation system?
The specifications do not list explicit sizes or models, but as a DHS/DCS Plate System, it is designed to accommodate various proximal femur fracture patterns. Clinicians should refer to the manufacturer’s surgical technique guide (if available) or consult with orthopedic specialists to match the appropriate plate and screw configuration to the patient’s anatomy and fracture type for optimal fixation.
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: Syntec-taichung Non-sterile Dhs/Dcs Plate System, SYNTEC-TAICHUNG NON-STERILE DHS/DCS PLATE SYSTEM 510 (k) K983873 - FDA ..., K983873 - Syntec-taichung Non-sterile Dhs/Dcs Plate System, Syntec-taichung Non-sterile Dhs/Dcs Plate System - Beudamed
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K983873 | Class II | Active |
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Manufacturer
- Manufacturer
- Syntec Scientific Corp.
Sources (1)
- FDA 510(k) K983873 24 fields · synced Sep 20, 2026