Ray Tfc Device/Ray Tfc Unite Device

• • Terminated Z-0151-2009 FDA Unclassified (pre-2012) ·initiated 18 Aug 2008

  The label on one side on the Ray TFC Device (Ray Cage) is incorrect. It reads 20 mm x 26 mm instead of 20 mm x 21 mm.

Trade Name

Ray Threaded Fusion Cage (Tfc)(Tm) with Instrumentation

Generic Name

Intervertebral fusion device with bone graft, lumbar

PMA Number

P950019 ↗

FDA Product Code

MAX

Device Class

Class II

Regulation

21 CFR Part 888.3080

Advisory Committee

Orthopedic

FDA Decision

APRL

• Tritanium® C Anterior Cervical Cage

  Class II

  FDA 510(k) K262061 Active Cleared 17 Jul 2026

• Modification to Xia 4.5 Spinal System

  Class II

  FDA 510(k) K060748 Active Cleared 13 Apr 2006

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  Class II

  FDA 510(k) K222684 Active Cleared 8 Jun 2023

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  Class II

  FDA 510(k) K133188 Active Cleared 17 Dec 2013

• Stryker Spine Vlift Vertebral Body Replacement System

  Class II

  FDA 510(k) K060506 Active Cleared 25 May 2006

• Xia 3 Spinal System

  Class II

  FDA 510(k) K113666 Active Cleared 28 Aug 2012

See all devices from Stryker Spine →

• What types of spinal procedures is the Ray TFC Device designed to assist with, and how does it work?

  The Ray Threaded Fusion Cage (TFC) with Instrumentation is specifically designed for lumbar spinal applications to facilitate intervertebral fusion. It provides structural support between vertebrae while promoting bone growth, helping to stabilize the spine and encourage proper healing. The threaded design allows for secure placement and fixation, ensuring long-term stability during the fusion process.

• Is the Ray TFC Device intended for repeated use, or is it meant to be used once and then discarded?

  The Ray TFC Device is explicitly labeled for single-use only. After implantation, it is not designed or intended to be removed or reused, as this could compromise patient safety and device integrity. Always follow manufacturer guidelines for proper disposal after a single surgical procedure.

• What sizes are available for the Ray TFC Device, and how do I determine the correct size for a patient?

  The Ray TFC Device comes in multiple sizes as specified by Stryker Spine, tailored to accommodate different lumbar spinal anatomies. The correct size is determined by preoperative imaging (e.g., CT or MRI) and surgical planning, ensuring proper fit and alignment. Consult the manufacturer’s sizing charts or surgical guidelines for precise selection based on vertebral dimensions.

• Does the Ray TFC Device come with any tools or accessories, and if so, what are they included?

  Yes, the Ray TFC Device is supplied with instrumentation, meaning it includes the necessary surgical tools required for proper implantation. These tools are designed to assist in precise placement and fixation of the threaded fusion cage during lumbar spinal procedures. The full set should be available in the manufacturer’s surgical kit.

• How should the Ray TFC Device be stored to maintain its sterility and functionality before use?

  The Ray TFC Device must be stored in its original, unopened packaging in a clean, dry environment protected from moisture, extreme temperatures, and direct sunlight. Follow Stryker Spine’s storage instructions to preserve sterility and structural integrity until immediate preoperative use. Never reuse or restock sterile components.