Pins and Wires
510(k) K002125
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK002125 | Date11 Oct 2000 | 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- Withdrawn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
- HTY
- 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
This device consists of orthopedic pins and wires, classified under the FDA product code HTY. It is designed for internal fixation in orthopedic procedures, providing structural support to stabilize bone fragments or joints during the healing process. The pins and wires are intended for use in surgical applications where rigid fixation is required, such as fracture repair or joint reconstruction. Their design ensures secure attachment to bone, aiding in proper alignment and immobilization.
The pins and wires are supplied as reusable medical devices, as indicated by the FDA 510(k) clearance under K002125. They are manufactured from materials suitable for orthopedic applications and undergo rigorous quality control to ensure reliability. The device is regulated under the Orthopedic Advisory Committee (OR) and is intended for use in sterile surgical environments. No specific sterility or single-use designation is stated in the provided data, but compliance with FDA standards for orthopedic fixation devices applies.
Other devices from Implant Resource, Inc.
Questions
AI-generated answers, 1 Oct 2026
What are these pins and wires used for in orthopedic surgery?
These pins and wires are designed for internal fixation in orthopedic procedures, providing rigid structural support to stabilize bone fragments or joints during healing. They are specifically intended for surgical applications where precise alignment and immobilization are critical, such as fracture repair or joint reconstruction. Their secure attachment to bone ensures proper positioning while the healing process occurs.
Are these pins and wires single-use or reusable?
These pins and wires are classified as reusable medical devices, as confirmed by their FDA 510(k) clearance under K002125. Reusability is determined by the manufacturer’s design, manufacturing standards, and regulatory submission, ensuring they meet the necessary durability and safety criteria for repeated use in sterile surgical environments.
What materials are used in the construction of these pins and wires?
The pins and wires are manufactured from materials suitable for orthopedic applications, though the exact composition is not specified in the provided data. They undergo rigorous quality control to ensure reliability, compliance with FDA standards, and safe performance in surgical settings where bone stabilization is required.
How should these pins and wires be stored before use?
While specific storage instructions are not detailed in the provided data, reusable orthopedic fixation devices like these must be stored in a clean, dry environment to prevent contamination. They should be packaged or handled according to manufacturer guidelines to maintain sterility and integrity before surgical use, as they are intended for sterile environments.
What regulatory body oversees the approval of these pins and wires?
These pins and wires are regulated by the U.S. Food and Drug Administration (FDA) under the Orthopedic Advisory Committee (OR) and fall under product code HTY. Their clearance was granted through a traditional 510(k) review process, demonstrating substantial equivalence to a legally marketed predicate device, ensuring compliance with FDA standards for orthopedic fixation devices.