Kangli Locking Plate System
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K133840 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 Kangli Locking Plate System is a locking plate device classified under orthopedic implants, designed for internal fixation of bone fractures. It features a modular construct with locking screws to stabilize long bone fractures, including those of the tibia, ensuring secure alignment and promoting proper healing through rigid fixation.
This system is supplied sterile and intended for single-use, adhering to FDA 510(k) clearance under Traditional review (K133840) and MDR compliance. It is intended for adult patients and must be used in sterile surgical settings by trained professionals. The system includes various plate sizes and screw configurations, with MRI safety considerations noted in the manufacturer’s specifications.
Frequently asked questions
What types of bone fractures is the Kangli Locking Plate System specifically designed to stabilize, and how does it achieve this?
The Kangli Locking Plate System is designed for internal fixation of long bone fractures, particularly those of the tibia. It achieves secure stabilization through a modular locking plate construct with locking screws, which provide rigid fixation to maintain proper alignment and promote proper healing. The locking mechanism ensures the plate remains securely attached to the bone, reducing the risk of displacement during recovery.
Is the Kangli Locking Plate System intended for reuse, or is it meant to be used only once per patient? Why does this matter?
The Kangli Locking Plate System is explicitly intended for single-use only, as stated in the manufacturer’s specifications. This matters because single-use devices minimize the risk of cross-contamination and infection in sterile surgical settings, ensuring patient safety and compliance with medical best practices. Reuse could compromise sterility and integrity, potentially leading to complications.
What plate sizes and screw configurations are available in the Kangli Locking Plate System, and how might this modularity benefit surgeons?
While the exact plate sizes and screw configurations aren’t detailed in the provided data, the system is described as modular, meaning it includes various plate sizes and screw configurations to accommodate different fracture patterns and anatomical needs. This modularity allows surgeons to customize the fixation setup for optimal stability, fit, and healing outcomes, improving adaptability across cases.
How should the Kangli Locking Plate System be stored, and what precautions should be taken given its sterile and single-use nature?
Since the system is supplied sterile and intended for single-use, it must be stored in its original, unopened packaging to preserve sterility. Storage should follow the manufacturer’s guidelines, typically in a clean, dry environment protected from extreme temperatures, moisture, and physical damage. Once opened, the components should only be used immediately in a sterile surgical field to prevent contamination.
Are there any special considerations for using the Kangli Locking Plate System in patients who may require MRI scans after surgery?
The manufacturer notes MRI safety considerations in the specifications for the Kangli Locking Plate System, though specific details (e.g., compatibility with certain MRI strengths or sequences) aren’t provided here. Clinicians should consult the device’s labeling or the manufacturer’s instructions for MRI safety information to ensure safe imaging post-surgery, as some orthopedic implants may pose risks in MRI environments.
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: Orthopaedic Implant Manufacturer | Kangli Orthopaedics, Suzhoushi Kangli Orthopaedics Ienstrument CO.Ltd, Suzhou Kangli Orthopaedics Instrument Co., Ltd., Kangli Locking Plate System by SUZHOU KANGLI ORTHOPAEDICS INSTRUMENT CO ..., Kangli Catalogue 2023 • Kangli Orthopaedics - kanglimed.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 | K133840 | Class II | Active |
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Manufacturer
- Manufacturer
- Suzhou Kangli Orthopaedics Instrument Co., Ltd.
Sources (2)
- FDA 510(k) K133840 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 28, 2026