Dynasty Biofoam Shell
by Wrightmedicaltechnologyinc 510(k)
Active
510(k) K121544
Overview
The Dynasty Biofoam Shell is a semi-constrained, uncemented acetabular component for total hip arthroplasty. It features a titanium alloy substrate with a commercially pure titanium BIOFOAM® coating, designed to integrate with bone and support hip joint function.
This device is intended for use in orthopedic surgery settings and is supplied as a reusable surgical implant. It is classified under product code KWA and has received FDA 510(k) clearance for substantial equivalence. The component is not described as sterile or single-use in the provided data, and no MRI safety information is specified.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK121544 | Date30 Jul 2012 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
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
Other devices from Wrightmedicaltechnologyinc
Questions
What types of patients is the Dynasty Biofoam Shell designed for in total hip arthroplasty procedures?
The Dynasty Biofoam Shell is designed for use in total hip arthroplasty procedures as a semi-constrained, uncemented acetabular component. It is intended for patients requiring hip joint replacement, particularly those who may benefit from a titanium alloy substrate with a BIOFOAM® coating to promote bone integration and support joint function. The device is not specified for any particular patient subgroup beyond standard orthopedic hip replacement indications.
Is the Dynasty Biofoam Shell reusable or single-use, and how should it be handled during surgery?
The Dynasty Biofoam Shell is explicitly described as a reusable surgical implant. Since it is not labeled as sterile or single-use, it must be sterilized and processed according to established medical device reprocessing protocols before reuse. Proper cleaning, inspection, and sterilization are critical to ensure safety and functionality for subsequent procedures.
What materials is the Dynasty Biofoam Shell made of, and how does the coating contribute to its function?
The Dynasty Biofoam Shell features a titanium alloy substrate with a commercially pure titanium BIOFOAM® coating. The BIOFOAM® coating is designed to enhance osseointegration—meaning it promotes direct bonding between the implant and surrounding bone—while the titanium alloy provides structural integrity and durability for long-term hip joint function.
How do I determine if a specific size or model of the Dynasty Biofoam Shell is compatible with my patient’s anatomy?
The Dynasty Biofoam Shell comes in multiple sizes and models, as indicated by the extensive list of FEI numbers (e.g., 3020282716, 3007923096) and registration numbers in the data. These identifiers correspond to different acetabular component dimensions. Consult the manufacturer’s sizing guides or your orthopedic surgeon’s preferred implant selection tools to match the correct size to your patient’s acetabular anatomy and surgical needs.
What regulatory pathway was followed for FDA clearance of the Dynasty Biofoam Shell, and how does this affect its use?
The Dynasty Biofoam Shell received FDA 510(k) clearance under the Traditional Review pathway, with a decision of Substantially Equivalent (SESE) to a predicate device. This means it was determined to have the same intended use and technological characteristics as a previously cleared device, ensuring compliance with FDA requirements for safety and effectiveness. Clinicians and buyers can rely on this clearance as evidence of regulatory review, though they should always follow institutional protocols and manufacturer instructions for proper use.