Apex Kirschner Wires and Steinmann Pins
by Apex Tools & Orthopedics Co. 2 variants
510(k) K121004
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK121004 | Date24 Apr 2012 | 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- Withdrawn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
The Apex Kirschner Wires and Steinmann Pins are metallic orthopedic fixation devices classified as orthopedic pins and wires. These devices are designed for bone fracture fixation, bone reconstruction, and as guide pins for implant insertion or traction applications through the skin.
Supplied in various diameters, lengths, and point geometries, these pins are available in both threaded and non-threaded designs. They are intended for single-use in sterile surgical settings and comply with FDA 510(k) clearance under product code HTY, with authorization for orthopedic use. Storage and handling must adhere to sterile medical device protocols.
Other devices from Apex Tools & Orthopedics Co.
Questions
AI-generated answers, 1 Oct 2026
What are Apex Kirschner Wires and Steinmann Pins used for?
These devices are designed for orthopedic applications, including bone fracture fixation, bone reconstruction, and as guide pins for implant insertion or traction. They are inserted through the skin to stabilize fractures or assist in surgical procedures where precise alignment is critical.
Are these pins single-use or reusable?
The Apex Kirschner Wires and Steinmann Pins are intended for single-use only in sterile surgical settings. Reuse is not recommended due to potential contamination risks and loss of sterility, which could compromise patient safety and device performance.
What sizes and designs are available for these pins?
These pins come in various diameters, lengths, and point geometries, including both threaded and non-threaded designs. The specific configurations are tailored to accommodate different surgical needs, such as fracture stabilization or implant guidance, ensuring versatility in orthopedic procedures.
How should these devices be stored to maintain sterility?
Storage and handling must follow sterile medical device protocols to preserve integrity. The packaging should remain unopened until use, and the devices should be stored in a clean, dry environment away from direct sunlight or extreme temperatures to prevent contamination or degradation.
Are these pins FDA-cleared, and what does that mean for their use?
Yes, these devices hold FDA 510(k) clearance under product code HTY, with a determination of substantial equivalence to predicate devices. This means they meet regulatory standards for safety and effectiveness as orthopedic pins and wires, allowing them to be legally marketed and used in the U.S. for their intended purposes.