Stryker Injectable Cement
510(k) K060061
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK060061 | Date1 Mar 2006 | 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- Withdrawn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
- MQV
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3045
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Stryker Injectable Cement is a calcium phosphate bone void filler (Product Code: MQV), classified under orthopedic devices. It is a self-setting, injectable material designed to fill cranial defects, including neurosurgical burr holes, contiguous craniotomy cuts, and other non-load-bearing bony defects. Its composition enables in situ hardening, providing structural support and contour restoration for craniofacial applications.
This device is supplied as a sterile, single-use material and is intended for use in neurosurgical and craniofacial procedures. It requires no additional mixing or curing beyond application, offering convenience in on-demand use. The product is regulated under FDA 510(k) clearance (K060061) and is manufactured by Stryker Corp., Kalamazoo, MI. Storage and handling must comply with sterile medical device protocols to ensure integrity prior to use.
Other devices from Stryker Corp.
Questions
AI-generated answers, 1 Oct 2026
What is the Stryker Injectable Cement used for?
The Stryker Injectable Cement is designed to fill non-load-bearing bony defects in craniofacial applications, such as cranial defects from neurosurgical burr holes, contiguous craniotomy cuts, or other similar voids. Its self-setting, injectable composition allows it to harden in situ, providing structural support and restoring contour without requiring additional mixing or curing steps.
How is the Stryker Injectable Cement supplied and prepared for use?
The Stryker Injectable Cement is supplied as a sterile, single-use material, ready for immediate application in neurosurgical or craniofacial procedures. No additional mixing or curing is required—it hardens upon application, offering convenience for on-demand use.
Is the Stryker Injectable Cement reusable or intended for single-use?
The Stryker Injectable Cement is explicitly intended for single-use only. This ensures sterility and safety for each procedure, as reuse could compromise the material’s integrity and risk contamination.
What storage and handling requirements apply to the Stryker Injectable Cement?
The Stryker Injectable Cement must be stored and handled according to sterile medical device protocols to maintain its integrity before use. This includes proper packaging, temperature control, and protection from contamination to ensure the material remains sterile and effective for its intended application.
What regulatory clearance does the Stryker Injectable Cement hold?
The Stryker Injectable Cement holds FDA 510(k) clearance under the product code MQV (K060061), classified as substantially equivalent to a predicate device. This clearance is specific to its use as a bone void filler in orthopedic applications, particularly for cranial defects.