Metallic Locking Compression Bone Plates and Screws System
by Tianjin Walkman Biomaterial Co., Ltd.
510(k) K131759
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK131759 | Date8 Aug 2013 | 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- Withdrawn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
This device is a metallic locking compression bone plate and screw system, classified under the nomenclature for Plate, Fixation, Bone. It combines locking screw technology with conventional plating techniques to provide stable internal fixation for bone fractures, ensuring secure alignment and compression during the healing process. The system is designed to maintain proper bone positioning while allowing for controlled stability, reducing the risk of displacement or loosening. Its modular components enable customisation to various fracture patterns and anatomical sites.
The system is supplied as a reusable orthopedic hardware assembly, intended for use in surgical settings by trained medical professionals. Components are typically sterilised via ethylene oxide or gamma irradiation before packaging. The device is MRI-unsafe due to its metallic construction, requiring careful handling in imaging environments. Sizes and configurations vary to accommodate different bone types and fracture locations, with detailed sizing guides provided in the manufacturer’s technical documentation. Authorised for use in the United States under FDA 510(k) clearance (K131759), it adheres to Class II special controls for bone fixation devices.
Other devices from Tianjin Walkman Biomaterial Co., Ltd.
Questions
AI-generated answers, 1 Oct 2026
What is the primary use of the metallic locking compression bone plates and screws system?
This system is designed for internal fixation of bone fractures, providing stable alignment and compression during the healing process. The modular components allow customisation to fit various fracture patterns and anatomical sites, ensuring secure positioning while allowing controlled stability to reduce displacement or loosening risks.
How is the metallic locking compression bone plates and screws system supplied and sterilised?
The system is supplied as a reusable orthopedic hardware assembly intended for surgical use by trained medical professionals. Components are sterilised via ethylene oxide or gamma irradiation before packaging to ensure safety and sterility.
Is this system single-use or reusable?
The metallic locking compression bone plates and screws system is designed for reuse. It is intended to be sterilised between uses in a clinical setting, adhering to standard orthopedic hardware reprocessing protocols.
What sizes and configurations are available for this system?
The system offers multiple sizes and configurations to accommodate different bone types and fracture locations. Detailed sizing guides are provided in the manufacturer’s technical documentation to assist clinicians in selecting the appropriate components for each case.
Can this system be used safely in MRI environments?
No, this system is MRI-unsafe due to its metallic construction. Careful handling is required in imaging environments to avoid interference with MRI scans, as the metal components may distort images or pose safety risks.