TDM Screw System
510(k) K231860
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK231860 | Date18 Jan 2024 | 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- Withdrawn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
- HWC
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3040
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The TDM Screw System is a metallic orthopedic fixation device classified under Smooth or Threaded Metallic Bone Screws (21 CFR 888.3040). It is designed for internal fixation of long bone fractures, fusions, osteotomies, non-unions, and malunions, providing stable alignment and mechanical support during bone healing. Constructed from metallic materials, these screws are engineered to secure bone fragments or implants in place, facilitating skeletal restoration and mobility recovery. The system is intended for use in orthopedic procedures where rigid fixation is required, ensuring proper alignment and load distribution across the fracture site.
The TDM Screw System is supplied as a sterile, single-use orthopedic implant intended for surgical application under aseptic conditions. It is regulated under FDA 510(k) clearance (K231860) as substantially equivalent to predicate devices, adhering to orthopedic fixation standards. Available in sizes and configurations appropriate for specific bone types and fracture patterns, the system requires surgical placement by trained professionals in controlled operating room environments. No MRI safety data is specified, and proper disposal or reprocessing (if reusable) must follow institutional protocols. Compliance with 21 CFR 888.3040 ensures adherence to manufacturing, labeling, and performance requirements for metallic bone screws.
Other devices from TDM Co., Ltd.
Questions
AI-generated answers, 1 Oct 2026
What is the TDM Screw System used for?
The TDM Screw System is designed for internal fixation of long bone fractures, fusions, osteotomies, non-unions, and malunions. It provides stable alignment and mechanical support to facilitate bone healing and skeletal restoration during orthopedic procedures requiring rigid fixation.
How is the TDM Screw System supplied and intended for use?
The system is supplied as a sterile, single-use orthopedic implant. It is intended exclusively for surgical application under aseptic conditions in controlled operating room environments by trained professionals. This ensures proper infection control and adherence to clinical best practices.
Are the TDM Screw System screws reusable or single-use?
The TDM Screw System is explicitly designed for single-use only. This design choice aligns with FDA 510(k) clearance requirements and clinical protocols to maintain sterility and patient safety during orthopedic procedures.
What sizes and configurations are available for the TDM Screw System?
The TDM Screw System is available in multiple sizes and configurations tailored to specific bone types and fracture patterns. Exact dimensions and options should be referenced in the manufacturer’s technical documentation or surgical guides, as they are optimized for precise fixation requirements.
What storage and handling precautions should be taken for the TDM Screw System?
The system must be stored in its original, unopened packaging to preserve sterility until immediate preoperative use. Handling should follow aseptic techniques to prevent contamination, and any unused portions must be discarded per institutional protocols to avoid compromise of sterile integrity.