PEEK Tetris Spinal Implant

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K031757 ↗

FDA Product Code

MQP

Device Class

Class II

Regulation

21 CFR Part 888.3060

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Monopoly Pedicle Screw System

  Class II

  FDA 510(k) K081108 Active Cleared 14 Jul 2008

• Tetris Spinal Implant

  Class II

  FDA 510(k) K022793 Active Cleared 8 Apr 2003

• Rabea Cement Restrictor

  Class II

  FDA 510(k) K020836 Active Cleared 11 Jun 2002

• Nubic Spinal Implant

  Class II

  FDA 510(k) K052096 Active Cleared 16 Aug 2005

• Conklusion Pedicle Screw System

  Class II

  FDA 510(k) K031455 Active Cleared 22 Oct 2003

• Diana Fusion Cage

  Class II

  FDA 510(k) K091122 Active Cleared 18 Sep 2009

See all devices from Signus Medical →

• What types of spinal procedures is the PEEK Tetris Spinal Implant specifically designed for, and why is this important for clinicians?

  The PEEK Tetris Spinal Implant is designed specifically for posterior lumbar interbody fusion (PLIF) procedures between vertebral levels L1 and S1. This is important for clinicians because PLIF is a common surgical approach for addressing lumbar spine instability, degenerative disc disease, or spinal deformities, and the implant’s modular design allows for precise anatomical adaptation to stabilize the lumbar region effectively during these procedures.

• Is the PEEK Tetris Spinal Implant reusable, or is it intended for single-use only? How does this affect its sterility and handling?

  The PEEK Tetris Spinal Implant is sterile and intended for single-use only. This design choice ensures patient safety by eliminating the risk of cross-contamination or degradation from repeated sterilization processes. As a result, strict sterile medical device protocols must be followed during storage and handling to maintain its integrity before use.

• What materials is the PEEK Tetris Spinal Implant made from, and how do these materials contribute to its performance in spinal fusion?

  The implant is constructed from polyetheretherketone (PEEK), a radiolucent material that allows for clear radiographic visualization during and after surgery. It also includes titanium alloy marker pins, which enhance imaging accuracy. PEEK’s biomechanical properties provide long-term stability, while its modular design with lateral fenestrations and wall spikes ensures secure vertebral anchorage, making it ideal for spinal fusion procedures.

• What size variations or configurations are available for the PEEK Tetris Spinal Implant, and why does this modularity matter for surgeons?

  The PEEK Tetris Spinal Implant features a modular design with various sizes and wedge configurations to accommodate different patient anatomies and pathologies. This modularity is critical for surgeons because it allows for customized placement between vertebral levels L1 and S1, improving fit, stability, and fusion outcomes tailored to individual patient needs.

• How should the PEEK Tetris Spinal Implant be stored, and what precautions should be taken to ensure its sterility and usability?

  The implant must be stored and handled according to sterile medical device protocols to preserve its integrity. Since it is single-use and sterile, it should remain in its original packaging until immediately before use, protected from contamination, moisture, or physical damage. Proper storage ensures it remains ready for surgical application without compromising its performance or safety.