Preserve Hip Stem
by Wrightmedicaltechnologyinc 510(k)
Active
510(k) K112080
Overview
The Preserve Hip Stem is a Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) designed for orthopedic use. This device is intended for use in total hip arthroplasty, providing a metal-based, uncemented acetabular component to restore hip function and stability in patients with degenerative joint disease or trauma.
The Preserve Hip Stem is supplied as a reusable surgical implant and is intended for use in controlled clinical settings such as orthopedic operating rooms. It is regulated under FDA 510(k) clearance (K112080) and falls under Class III medical device classification (regulation number 888.3330). Multiple FEI numbers (e.g., 3020282716, 3007923096) correspond to its various configurations, ensuring traceability and compliance with regulatory requirements.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK112080 | Date28 Dec 2011 | 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- Withdrawn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 Preserve Hip Stem designed to help, and how does it differ from cemented acetabular components?
The Preserve Hip Stem is specifically designed for patients undergoing total hip arthroplasty due to degenerative joint disease or trauma. Unlike cemented acetabular components, this device is uncemented and metal-based, meaning it is intended to integrate directly with the patient’s bone over time without the use of bone cement. This design is often preferred for patients with sufficient bone quality to support an uncemented implant, as it may reduce risks associated with cement, such as loosening or bone cement-related complications.
Is the Preserve Hip Stem reusable, and if so, what considerations should be taken during surgical procedures?
Yes, the Preserve Hip Stem is supplied as a reusable surgical implant, meaning it is intended for use in controlled clinical settings like orthopedic operating rooms. Reusability requires strict adherence to sterilization protocols and traceability measures (e.g., the listed FEI numbers) to ensure compliance with regulatory standards. Hospitals must follow manufacturer guidelines for cleaning, sterilization, and inventory tracking to maintain safety and efficacy between uses.
How do I determine the correct size or model of Preserve Hip Stem for a patient, and are there multiple configurations available?
The Preserve Hip Stem comes in multiple configurations, as indicated by the diverse FEI numbers (e.g., 3020282716, 3007923096) listed for regulatory traceability. These configurations likely correspond to different sizes, diameters, or anatomical adaptations to accommodate varying patient anatomies. Selection should be based on preoperative planning, including imaging and measurements, in consultation with the manufacturer’s sizing guides or surgical planning tools to ensure proper fit and function.
What regulatory pathway was followed for the FDA clearance of the Preserve Hip Stem, and how does this affect its use in clinical practice?
The Preserve Hip Stem received FDA 510(k) clearance (K112080) under a Special 510(k) pathway, with a determination of Substantially Equivalent (SESE) to a predicate device. This classification places it in Class III, indicating it is a higher-risk device requiring stringent regulatory oversight. Clinically, this means the device has undergone rigorous review for safety and effectiveness, and its use must comply with FDA-mandated labeling, training, and post-market surveillance requirements to ensure continued performance and patient safety.