OS2-C Compression Staple
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by In2Bones SAS
Identifiers
- 510(k) Number
- K153395 FDA 510(k)
- FDA Product Code
- JDR FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3030 FDA 510(k)
- Regulation Number
- 888.3030 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The OS2-C Compression Staple is a surgical orthopedic device classified as a compression staple, designed to approximate and secure bone fragments during orthopedic procedures. It provides mechanical stability to promote proper healing of fractures or osteotomies, particularly in long bones or joint reconstructions.
This device is supplied sterile and intended for single-use. It is regulated under the FDA’s 510(k) pathway with a Traditional review, classified under product code JDR (Orthopedic Devices, Bone Staples). Compliance with the EU MDR is also noted, ensuring adherence to stringent safety and performance standards. The staple is available in a standardized size as specified in the submission.
Frequently asked questions
What types of orthopedic procedures is the OS2-C Compression Staple primarily used for, and how does it contribute to healing?
The OS2-C Compression Staple is designed to approximate and secure bone fragments during orthopedic procedures involving long bones or joint reconstructions, such as fractures or osteotomies. It provides mechanical stability to help maintain proper alignment, which promotes optimal healing by reducing micromotion at the fracture site.
Is the OS2-C Compression Staple intended for reuse, or is it meant to be used only once?
The OS2-C Compression Staple is explicitly intended for single-use only. This is a standard practice for surgical orthopedic devices to ensure sterility and patient safety, as reuse could compromise integrity and introduce infection risks.
How is the OS2-C Compression Staple supplied, and what does the sterile packaging ensure?
The OS2-C Compression Staple is supplied sterile in its packaging, which means it is pre-sterilized to meet surgical standards. This ensures the device is free from contaminants before use, reducing infection risks during orthopedic procedures.
What regulatory pathways does the OS2-C Compression Staple follow, and how does this affect its use?
The OS2-C Compression Staple is regulated under the FDA’s 510(k) pathway with a Traditional review (K153395) and complies with the EU MDR. These pathways ensure the device meets safety and performance standards before clinical use, providing confidence in its reliability for orthopedic applications.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K153395 | Class II | Active |
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Manufacturer
- Manufacturer
- In2Bones SAS
Sources (2)
- FDA 510(k) K153395 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026