Osteo-Site Bone Biopsy Needle, Osteo-Site Bone Biopsy Needle Set
510(k) K170008
Active
Valid until
Not listed
FDA recalls
None foundTrust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK170008 | Date28 Feb 2017 | StatusActive |
| European Union | CE/MDD EUDAMED | Number— | Date— | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA Product Code
- KNW
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.1075
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The Osteo-Site Bone Biopsy Needle and Needle Set are designed for percutaneous bone biopsy procedures. This device features a radiolucent handle and a sharpened cutting tip on the outer cannula, enabling precise needle placement and maintaining access for tissue sampling.
The set is intended for use in clinical settings such as interventional radiology or orthopedic surgery. Supplied sterile for single-use, the needle set includes a cannula marked with 1 cm increments to assist in depth measurement. Authorized under FDA 510K and MDD compliance, it adheres to regulatory standards for bone biopsy instruments.
Other devices from Cook Incorporated
Questions
AI-generated answers, 18 Sep 2026
What clinical specialties commonly use the Osteo-Site Bone Biopsy Needle Set, and why is it designed for those procedures?
The Osteo-Site Bone Biopsy Needle Set is primarily used in interventional radiology and orthopedic surgery settings. Its design—including a radiolucent handle for visibility under imaging and a sharpened cutting tip on the outer cannula—enables precise, percutaneous (through-the-skin) bone biopsy procedures. The 1 cm incremental markings on the cannula also assist clinicians in accurately measuring depth during sampling, which is critical for both diagnostic accuracy and patient safety in these specialties.
Is the Osteo-Site Bone Biopsy Needle Set reusable, or is it intended for single-use only? How does this affect its sterility?
The Osteo-Site Bone Biopsy Needle Set is sterile for single-use only, as explicitly stated in the manufacturer’s description. This design choice ensures patient safety by eliminating cross-contamination risks associated with reuse. Single-use also aligns with clinical best practices for invasive procedures like bone biopsies, where sterility is paramount to prevent infection.
What regulatory pathways does the Osteo-Site Bone Biopsy Needle Set follow, and what does this mean for its use in clinical practice?
The device is authorized under FDA 510K clearance (K170008) and MDD compliance, meaning it has undergone a premarket review to demonstrate substantial equivalence to a legally marketed predicate device. This regulatory route confirms the device meets U.S. and EU safety and performance standards for bone biopsy instruments, allowing clinicians to use it with confidence in procedures like diagnostic sampling or tumor evaluation.
How does the radiolucent handle feature of the Osteo-Site Bone Biopsy Needle Set benefit the procedure?
The radiolucent handle allows the needle to be clearly visualized under fluoroscopy or X-ray imaging during the biopsy procedure. This feature is essential for guiding the needle to the precise target site within the bone, ensuring accurate tissue sampling while minimizing risks like nerve or vessel damage. It’s particularly valuable in procedures where real-time imaging is critical, such as in interventional radiology.