Stability Hip Femoral Component
by Depuy, Inc. 510(k)
Active
510(k) K915594
Overview
The Stability Hip Femoral Component is a cementless hip stem designed for total hip arthroplasty, intended to provide primary stability within the femoral canal. Classified under orthopedic device nomenclature, it is engineered to offer structural support and alignment for hip joint replacement procedures, ensuring long-term implant fixation without the use of bone cement.
This device is supplied as a reusable surgical implant, intended for use in orthopedic settings by trained surgeons. It is not sterile at the time of supply but is intended to be sterilized prior to use, adhering to standard medical device sterilization protocols. The product is regulated under the FDA’s 510(k) clearance process, with a traditional review pathway, and is categorized under product code JDI for femoral components. No additional regulatory status beyond the stated FDA_510K clearance is implied.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK915594 | Date14 Apr 1993 | 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- Withdrawn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
- JDI
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3350
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Other devices from Depuy, Inc.
Questions
What types of hip replacement surgeries is the Stability Hip Femoral Component intended for, and how does it achieve stability without cement?
The Stability Hip Femoral Component is designed specifically for total hip arthroplasty procedures, where it serves as a cementless femoral stem. Its primary function is to provide primary stability within the femoral canal by relying on a press-fit design that engages the bone’s natural geometry, eliminating the need for bone cement. This approach aims to ensure long-term implant fixation through osseointegration—where the bone grows into and around the implant—rather than relying on adhesive fixation.
Is the Stability Hip Femoral Component sterile when received, and what sterilization methods are recommended before use?
No, the Stability Hip Femoral Component is not sterile at the time of supply. It is intended to be sterilized prior to use following standard medical device sterilization protocols, such as ethylene oxide (EtO) or gamma irradiation, which are commonly used for metallic orthopedic implants. Sterilization ensures safety for surgical use in orthopedic settings.
How is the Stability Hip Femoral Component categorized under regulatory classifications, and what does this mean for its use?
The Stability Hip Femoral Component is classified under FDA product code JDI, which corresponds to femoral components for hip joint replacement. It was cleared via the FDA’s 510(k) process with a traditional review pathway, meaning its safety and effectiveness were compared to a legally marketed predicate device (determined as substantially equivalent). This classification and clearance route apply to its use as a reusable surgical implant in orthopedic procedures by trained surgeons.
What distinguishes the Stability Hip Femoral Component from other femoral stems, particularly in terms of its design philosophy?
The defining feature of the Stability Hip Femoral Component is its cementless design, which prioritizes primary stability through mechanical interlock and osseointegration rather than adhesive fixation. Unlike cemented stems, it relies on the femoral canal’s anatomy to achieve fixation, reducing reliance on additional materials like bone cement while aiming to enhance long-term durability and integration with the host bone.