Osteotrans-OT Screw
510(k) K073312
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK073312 | Date13 May 2008 | 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- Withdrawn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 Osteotrans-OT Screw is a smooth or threaded metallic bone screw (21 CFR 888.3040), designed for orthopedic fixation. It is intended for use in bone stabilization procedures, providing secure attachment within cortical or cancellous bone. The device falls under the orthopedic category and is classified as a washer, bolt, or nut (HTN) under regulatory definitions. Its threaded or smooth surface facilitates mechanical anchoring in skeletal applications.
This screw is supplied as a single-use, sterile device and is intended for surgical use in orthopedic settings. It is regulated under 21 CFR 888.3040 and holds an FDA 510(k) clearance (K073312) as substantially equivalent to predicate devices. No third-party review was involved in its clearance process. Storage and handling must comply with sterile surgical instrument protocols to ensure integrity prior to use.
Other devices from Takiron Co., Ltd.
Questions
AI-generated answers, 1 Oct 2026
What is the Osteotrans-OT Screw used for?
The Osteotrans-OT Screw is designed for orthopedic fixation, providing secure attachment within bone during stabilization procedures. Its threaded or smooth surface ensures mechanical anchoring in both cortical (dense outer bone) and cancellous (spongy inner bone) regions, making it suitable for skeletal applications requiring reliable fixation.
Is the Osteotrans-OT Screw sterile and single-use?
Yes, the Osteotrans-OT Screw is supplied as a sterile, single-use device. Sterility is critical for surgical applications, and its single-use nature ensures patient safety by preventing cross-contamination and maintaining device integrity for one surgical procedure only.
How should the Osteotrans-OT Screw be stored?
The screw must be stored and handled according to sterile surgical instrument protocols to preserve its integrity. This includes maintaining sealed packaging, avoiding contamination, and adhering to manufacturer guidelines for shelf life and environmental conditions to ensure readiness for surgical use.
What regulatory pathway does the Osteotrans-OT Screw follow?
The Osteotrans-OT Screw holds an FDA 510(k) clearance (K073312) under 21 CFR 888.3040, demonstrating substantial equivalence to predicate devices. The clearance was granted through a traditional review process without third-party involvement, confirming its compliance with regulatory standards for orthopedic fixation devices.
Are there different sizes or models of the Osteotrans-OT Screw?
The provided data does not specify distinct sizes or models beyond its classification as a metallic bone screw for orthopedic fixation. For exact dimensions or variations, refer to the manufacturer’s technical documentation or contact Takiron Co., Ltd. directly, as specifications may vary based on surgical requirements.