Bone Cement
by Zimmer, Inc.
PMA N17755
Active
Valid until
No expiry
FDA recalls
None foundDocuments
PMA N17755
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberN17755 | Date29 Sep 1982 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Full name
- Bonecement
- Generic name
- BONE CEMENT
- PMA number
- FDA product code
- LOD
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3027
- Advisory committee
- Orthopedic
- FDA decision
- APPR Approved
- PMA supplement
- S026
Overview
AI-generated summary, 18 Sep 2026
Bone Cement is a surgical adhesive used in orthopedic procedures to fixate prosthetic components, such as joint replacements, to bone. It is a polymethyl methacrylate (PMMA)-based material that hardens in situ to create a rigid bond, ensuring stability during bone healing and implant integration.
This device is supplied as a two-part system requiring mixing immediately before use and is intended for single-use only. It is classified as a Class II medical device under FDA regulations and has received Premarket Approval (PMA). Sterility is maintained through terminal sterilization, and compatibility with MRI environments is confirmed per manufacturer specifications. Various sizes and formulations are available to accommodate different clinical applications.
Other devices from Zimmer, Inc.
Questions
AI-generated answers, 18 Sep 2026
What types of orthopedic procedures is this bone cement designed to support, and how does it function during those procedures?
This bone cement is specifically designed to fixate prosthetic components, such as joint replacements, to bone during orthopedic procedures. It is a polymethyl methacrylate (PMMA)-based material that hardens in situ, creating a rigid bond between the implant and bone. This ensures stability during the critical healing period, facilitating proper implant integration and bone regeneration.
How is this bone cement supplied, and what preparation is required before use?
The bone cement is supplied as a two-part system, meaning it consists of separate components that must be mixed immediately before use. This ensures optimal performance and sterility, as it prevents premature hardening. The mixing process activates the polymerization, allowing the cement to harden in situ during the procedure.
Is this bone cement intended for single-use only, and if so, why?
Yes, this bone cement is intended for single-use only. The manufacturer specifies this to maintain sterility and ensure consistent performance, as reusing the cement could compromise its integrity, introduce contamination, or alter its chemical properties, potentially compromising patient safety and clinical outcomes.
What does the sterility assurance process involve for this bone cement, and how is it maintained?
The sterility of this bone cement is maintained through terminal sterilization, a process where the final product is exposed to a sterilizing agent or method (such as gamma irradiation or ethylene oxide) to eliminate all viable microorganisms. This ensures that each unit is sterile upon packaging and remains so until use, provided proper storage guidelines are followed.
Are there multiple sizes or formulations available for this bone cement, and how might a clinician determine the appropriate choice for a procedure?
Yes, multiple sizes and formulations of this bone cement are available to accommodate different clinical applications. The selection depends on factors such as the size and type of prosthetic component being implanted, the anatomical site, and the specific requirements of the procedure. Clinicians should refer to the manufacturer’s guidelines or product documentation to match the appropriate size or formulation to the patient’s needs and the surgical plan.