Locking Plate System
by Beijing Keyi Medical Device Technology Co., Ltd.
510(k) K162380
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK162380 | Date2 May 2017 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- HRS
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3030
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Locking Plate System is an orthopedic fixation device classified under the nomenclature for bone plates with locking screws. It is designed to stabilize and support long bone fractures, including those of the femur, tibia, and other weight-bearing bones, by providing rigid internal fixation through a combination of fixed-angle locking screws and a contoured plate.
This system is supplied as a sterile, single-use orthopedic implant intended for surgical use in operating rooms. It is regulated under FDA 510(k) clearance (K162380) as substantially equivalent to predicate devices, falling under Class II orthopedic instrumentation. The system is not MRI-safe and must be handled with sterile technique; proper storage requires adherence to manufacturer guidelines for orthopedic implants.
Other devices from Beijing Keyi Medical Device Technology Co., Ltd.
Questions
AI-generated answers, 1 Oct 2026
What types of fractures is the Locking Plate System designed to stabilize?
The Locking Plate System is specifically engineered to stabilize and support long bone fractures, including those of the femur and tibia, as well as other weight-bearing bones. Its design combines a contoured plate with fixed-angle locking screws to provide rigid internal fixation, ensuring secure alignment during the healing process. This makes it particularly suited for complex fractures requiring stable fixation to prevent displacement or malunion.
Is the Locking Plate System intended for reuse or single-use?
The Locking Plate System is supplied as a sterile, single-use orthopedic implant. This classification ensures patient safety by preventing cross-contamination and maintaining sterility throughout its intended surgical use. Single-use devices are designed for one-time application in a sterile operating room environment, adhering to best practices for orthopedic implants.
How should the Locking Plate System be stored to maintain sterility?
The Locking Plate System must be stored according to the manufacturer’s guidelines for orthopedic implants to preserve sterility. Proper storage typically involves keeping the device in its original, unopened packaging in a clean, dry environment, away from direct sunlight or extreme temperatures. Adherence to these instructions is critical to prevent contamination and ensure the device remains suitable for surgical use.
Can the Locking Plate System be used in MRI procedures?
No, the Locking Plate System is not MRI-safe. This means it should not be used in patients who require MRI imaging during their recovery, as the magnetic fields generated by MRI machines can interact with metallic implants, potentially causing heating, displacement, or other complications. Clinicians should confirm MRI safety with the manufacturer before proceeding with imaging.
What regulatory pathway does the Locking Plate System follow?
The Locking Plate System has received FDA clearance under the 510(k) pathway, specifically clearance number K162380. This classification confirms that the device is substantially equivalent to a predicate device and falls under Class II orthopedic instrumentation regulations. The clearance ensures it meets U.S. safety and performance standards for orthopedic fixation devices.