Gladiator Hip Stem
by Wrightmedicaltechnologyinc 510(k)
Active
510(k) K111910
Overview
The Gladiator Hip Stem is a Prosthesis, Hip, Semi-Constrained (Metal Uncemented) device, designed for total hip arthroplasty. It features a monolithic, straight titanium alloy (Ti6Al4V) construction with a rectangular cross-section, including a proximal trapezoidal section and a vertically tapered profile to enhance fixation stability in multiple planes.
This device is supplied sterile and intended for single-use in orthopedic surgical settings. It is classified as Class III under FDA regulations (510(k) clearance K111910) and adheres to regulatory requirements for uncemented hip prostheses. Multiple reference codes (e.g., 3002807113, 1047843) correspond to its various configurations, all manufactured to meet FDA standards for hip arthroplasty implants.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK111910 | Date14 Oct 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- Withdrawn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 surgical procedures is the Gladiator Hip Stem designed for, and why is this specific design chosen?
The Gladiator Hip Stem is designed specifically for total hip arthroplasty (replacement surgery) where an uncemented, semi-constrained metal prosthesis is required. Its monolithic titanium alloy (Ti6Al4V) construction with a rectangular cross-section, trapezoidal proximal section, and vertically tapered profile enhances stability in multiple planes, reducing the risk of loosening or rotation post-implantation. This design is ideal for patients needing durable, long-term fixation without bone cement.
Is the Gladiator Hip Stem reusable in the operating room, or is it intended for single-use only?
The Gladiator Hip Stem is sterile and intended for single-use only, as explicitly stated in the device description. This ensures patient safety by preventing cross-contamination and maintaining sterility standards for orthopedic implants. Reuse is not recommended or supported by the manufacturer.
What materials is the Gladiator Hip Stem made from, and how does this affect its performance?
The stem is constructed from titanium alloy (Ti6Al4V), a biocompatible material known for its strength, corrosion resistance, and compatibility with bone tissue. This alloy provides durability while minimizing the risk of adverse reactions, making it suitable for uncemented fixation where osseointegration (direct bone-to-implant bonding) is critical for long-term stability.
How should the Gladiator Hip Stem be stored before use, and what precautions should be taken?
Since the device is sterile and single-use, it should be stored in its original, sealed packaging in a clean, dry environment away from direct sunlight or extreme temperatures. The packaging must remain intact until immediately before use to preserve sterility. Avoid exposure to moisture, chemicals, or physical damage that could compromise its integrity.
What regulatory pathway was followed for FDA clearance of the Gladiator Hip Stem, and what does this mean for clinicians?
The Gladiator Hip Stem received FDA 510(k) clearance (K111910) under the Traditional 510(k) Review pathway, with a decision of Substantially Equivalent (SESE) to a predicate device. This means the FDA determined it has the same intended use and technological characteristics as a previously cleared hip prosthesis, ensuring it meets safety and effectiveness standards for uncemented, semi-constrained metal hip stems in total hip arthroplasty.