Dynasty Acetabular Shell and COCR Acetabular Liner
by Wrightmedicaltechnologyinc 510(k)
Active
510(k) K061844
Overview
This device is a Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component), classified under product code JDL. It consists of a metal acetabular shell and a cobalt-chromium (COCR) acetabular liner, designed to be cemented into the pelvis during total hip arthroplasty to restore joint function and mobility in patients with degenerative or traumatic hip joint damage.
The Dynasty Acetabular Shell and COCR Acetabular Liner is implanted in an orthopedic surgical setting using bone cement for fixation. It is intended for single-use and requires sterile handling. The device is regulated under FDA 510(k) clearance (K061844) and falls under Class III regulatory classification. Multiple sizes and variants are available, as indicated by the associated FEI numbers, and are supplied as a sterile, pre-packaged orthopedic implant system.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK061844 | Date6 Dec 2006 | 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- Withdrawn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
- JDL
- Device Class
- Class III
- Regulation
- 21 CFR Part 888.3320
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Other devices from Wrightmedicaltechnologyinc
Questions
What types of hip joint issues is this device designed to address in patients?
The Dynasty Acetabular Shell and COCR Acetabular Liner is specifically designed for use during total hip arthroplasty to restore joint function and mobility in patients suffering from degenerative or traumatic damage to the hip joint. It is intended for cemented fixation in the pelvis, providing a stable foundation for the hip replacement.
How is the device supplied, and what precautions should be taken during handling?
The device is supplied as a sterile, pre-packaged orthopedic implant system. Since it is intended for single-use only, sterile handling is critical to prevent contamination. The packaging ensures sterility, but it must remain unopened until immediately before use in the surgical setting.
Are there multiple sizes or variants available for this acetabular shell and liner, and how are they identified?
Yes, multiple sizes and variants of the Dynasty Acetabular Shell and COCR Acetabular Liner are available, each identified by unique FEI numbers. These numbers help clinicians select the appropriate size and variant for the patient’s anatomy and surgical requirements.
What regulatory pathway does this device follow, and what does that mean for its use?
This device follows the FDA 510(k) clearance pathway, specifically classified under product code JDL as a Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component). It is designated as substantially equivalent and falls under Class III regulatory classification, meaning it has undergone rigorous review to ensure safety and effectiveness for its intended use in orthopedic surgery.
How is the device fixed in place during surgery, and what materials are used?
The Dynasty Acetabular Shell and COCR Acetabular Liner is cemented into the pelvis using bone cement during total hip arthroplasty. The shell itself is made of metal, while the liner is composed of cobalt-chromium (COCR), providing durability and stability for the hip joint replacement.