Porous Titanium Acetabular Augments
510(k) K052888
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK052888 | Date6 Dec 2005 | 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- Withdrawn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
- KWA
- Device Class
- Class III
- Regulation
- 21 CFR Part 888.3330
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The Porous Titanium Acetabular Augments are semi-constrained, uncemented acetabular components designed for hip replacement surgery. These devices are constructed from porous titanium and are intended to provide structural support and stability to the acetabulum, facilitating proper hip joint function.
These augments are supplied as reusable medical devices and are regulated under FDA 510(k) clearance (K052888) as Class III orthopedic implants. They are used in orthopedic settings, typically during total hip arthroplasty procedures, and are available in multiple sizes as indicated by the associated FEI numbers. Sterility and MRI safety are not specified in the provided data.
Other devices from Biomet Manufacturing Corp
Questions
AI-generated answers, 18 Sep 2026
Are these acetabular augments designed for cemented or uncemented hip replacement procedures, and why does that matter?
The Porous Titanium Acetabular Augments are explicitly designed as uncemented components for hip replacement surgery. This distinction matters because uncemented implants rely on biological fixation—where the device integrates with the patient’s bone over time—rather than adhesive bonding with bone cement. The porous titanium structure promotes osseointegration, which is critical for long-term stability in uncemented applications.
How do I determine the correct size for a patient when selecting from the available FEI numbers?
The correct size is determined by preoperative planning and imaging, as the augments are supplied in multiple sizes indicated by their FEI numbers (e.g., 3002807113, 1047843). These numbers correspond to specific dimensions tailored to anatomical variations in acetabular morphology. Consulting the manufacturer’s sizing guides or working with an orthopedic surgeon ensures proper fit, as the augments are semi-constrained and must align with the patient’s pelvic anatomy for optimal function.
Are these augments intended for single-use or can they be reused in multiple procedures, and what does that imply for reprocessing?
The Porous Titanium Acetabular Augments are reusable medical devices, as explicitly stated in the data. This implies they must undergo strict reprocessing (cleaning, sterilization, and inspection) between uses to maintain safety and performance. Reusability is common for orthopedic implants in controlled environments like operating rooms, but it requires adherence to validated reprocessing protocols to prevent contamination or degradation of the porous titanium surface.
What should I consider when storing these augments to ensure they remain functional and safe for use?
While the data does not specify storage conditions, reusable orthopedic implants like these typically require dry, clean storage in a controlled environment to prevent corrosion, contamination, or damage. Porous titanium surfaces may be sensitive to moisture or chemical exposure, so storage should follow the manufacturer’s guidelines (if available) or industry standards for reusable metal implants. Avoid exposure to extreme temperatures or direct sunlight.