Vertebroplastic Radiopaque Bone Cement Modification
by Depuy Spine, A Johnson & Johnson Company 510(k)
Active
510(k) K071927
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK071927 | Date21 Nov 2007 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- Full name
- Modification to Vertebroplastic Radiopaque Bone Cement
- 510(k) Number
- FDA Product Code
- NDN
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3027
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
This device is a Cement, Bone, Vertebroplasty, classified as a Class II medical device under FDA regulation 888.3027. It is designed as a modification to existing radiopaque bone cement used in vertebroplasty procedures, where it is injected into fractured or compromised vertebral bodies to stabilise and reinforce the bone structure. The formulation includes radiopaque properties to enhance visibility under fluoroscopy or X-ray imaging during surgical placement.
The cement is supplied as a sterile, single-use material intended for orthopedic use in clinical settings. It is intended for use by trained surgeons in procedures such as vertebroplasty or kyphoplasty, where precise placement within the vertebral body is critical. The modification retains the original device’s regulatory clearance under an FDA 510(k) submission (K071927), classified as substantially equivalent to predicate devices. No additional sterility or MRI safety classifications are specified in the data.
Other devices from Depuy Spine, A Johnson & Johnson Company
Questions
AI-generated answers, 19 Sep 2026
What types of procedures is this radiopaque bone cement modification intended for, and why is the radiopacity important?
This modification to vertebroplastic radiopaque bone cement is specifically designed for procedures like vertebroplasty or kyphoplasty, where it is injected into fractured or compromised vertebral bodies to stabilize and reinforce the bone structure. The radiopacity is crucial because it enhances visibility under fluoroscopy or X-ray imaging, allowing surgeons to precisely monitor the placement of the cement within the vertebral body during the procedure.
Is this bone cement single-use or reusable, and how is it supplied?
The bone cement is supplied as a sterile, single-use material, meaning each package is intended for one surgical procedure only. This ensures patient safety and maintains sterility, which is critical in orthopedic interventions like vertebroplasty.
What regulatory pathway was followed for this modification, and how does it relate to the original device?
This modification was cleared through an FDA 510(k) submission (K071927) under the Special clearance type, classified as substantially equivalent to the predicate device. This means the FDA determined that the modification maintains the same intended use and technological characteristics as the original device, ensuring it meets regulatory standards for safety and effectiveness.
Are there any specific storage requirements mentioned for this bone cement?
The provided data does not explicitly detail storage requirements, but since it is a sterile, single-use medical device, it should be stored according to standard orthopedic device protocols—typically in a clean, dry environment, protected from contamination, and within the manufacturer’s recommended temperature and humidity ranges to preserve sterility and integrity.