Metal Transcend Articulation System (Larger Sizes)

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K021349 ↗

FDA Product Code

KWA

Device Class

Class III

Regulation

21 CFR Part 888.3330

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Profemur Z Classic Stems

  Class II

  FDA 510(k) K123434 Active Cleared 5 Feb 2013

• Cannulated Screw System

  Class II

  FDA 510(k) K143460 Active Cleared 23 Jan 2015

• Small Bone Wedge

  Class II

  FDA 510(k) K070592 Active Cleared 5 Oct 2007

• BIOFOAM Bone Wedge

  Class II

  FDA 510(k) K142724 Active Cleared 20 May 2015

• PROPHECY INVISION Preoperative Navigation Alignment System

  Class II

  FDA 510(k) K162795 Active Cleared 22 Feb 2017

• Salvation Beams and Bolts System

  Class II

  FDA 510(k) K140741 Active Cleared 15 May 2014

See all devices from Wrightmedicaltechnologyinc →

• What types of hip joint issues is the Metal Transcend Articulation System designed to address, and how does it differ from other acetabular components?

  The Metal Transcend Articulation System (Larger Sizes) is specifically designed to replace damaged or diseased hip joints by providing a semi-constrained, uncemented acetabular component. Unlike cemented alternatives, this system is intended for use without bone cement, which may be beneficial for patients with bone quality concerns. Its metal-on-metal articulation is engineered to enhance stability and mobility, making it suitable for complex cases where traditional components may not offer sufficient support.

• Is this device reusable, and if so, what considerations should be taken into account during surgical procedures?

  Yes, the Metal Transcend Articulation System is supplied as a reusable medical device. Since it is reusable, strict adherence to manufacturer guidelines for cleaning, sterilization, and maintenance is critical to ensure patient safety and device integrity. Proper sterilization protocols must be followed to prevent contamination between uses, and components should be inspected for wear or damage before reuse to maintain performance and reduce risks during surgery.

• What sizes and models are available for the Metal Transcend Articulation System, and how can I determine compatibility with my patient’s anatomy?

  The system is available in multiple sizes and reference codes, as listed in the regulatory records (e.g., FEI numbers like 3020282716, 3007923096, etc.). These variations ensure compatibility with different patient anatomies and surgical planning needs. To determine the appropriate size, consult preoperative imaging and measurements, or refer to the manufacturer’s sizing guides and surgical planning tools to select the correct component for optimal fit and function.

• How is the regulatory status of this device determined, and what does the FDA 510(k) clearance mean for its use in clinical practice?

  The Metal Transcend Articulation System has received FDA 510(k) clearance, which means it has been determined to be substantially equivalent to a legally marketed device already on the market. This clearance indicates that the device meets FDA standards for safety and effectiveness as outlined in the 510(k) submission process. Clinically, this allows surgeons to use it with confidence, knowing it has undergone rigorous review for performance and compliance with regulatory requirements.

• Are there any specific storage requirements for the Metal Transcend Articulation System to maintain its integrity before use?

  While the provided data does not explicitly detail storage conditions, reusable medical devices like this system generally require protection from moisture, dust, and physical damage. Storage should follow the manufacturer’s instructions to preserve sterility and functionality. If sterilization is required between uses, ensure the device is stored in a clean, dry environment and protected from contamination until the next surgical procedure.