Mecta-C with Titanium Markers and Mecta-C TiPEEK with Titanium Markers

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

510(k) Number

K172587 ↗

FDA Product Code

ODP

Device Class

Class II

Regulation

21 CFR Part 888.3080

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• M-Vizion Femoral Revision System Extension

  Class II

  FDA 510(k) K260173 Active Cleared 17 Sep 2026

• Mpact 3D Metal Foam

  Class II

  FDA 510(k) K253630 Active Cleared 28 Aug 2026

• MectaLIF 3D Metal Anterior

  Class II

  FDA 510(k) K254202 Active Cleared 5 May 2026

• MyPAO SA guides

  Class II

  FDA 510(k) K242603 Active Cleared 19 Nov 2025

• M.U.S.T. MINI Posterior Cervical Screws System Extension

  Class II

  FDA 510(k) K220570 Active Cleared 26 Apr 2022

• MectaLIF Anterior Lag Extension

  Class II

  FDA 510(k) K232123 Active Cleared 18 Oct 2023

See all devices from Medacta International S.A. →

• What types of materials are used in the Mecta-C and Mecta-C TiPEEK devices, and how does this affect their use in spinal procedures?

  The Mecta-C device features a titanium-coated material, while the Mecta-C TiPEEK variant incorporates PEEK (polyether ether ketone) with integrated titanium markers. Both are designed for cervical spine fusion procedures from C2 to T1. The titanium markers in both devices enhance radiographic visibility, which is critical for accurate intraoperative and postoperative assessment, ensuring proper alignment and stabilization during spinal fusion.

• Are these devices intended for reuse, or are they meant to be used only once? How should they be handled to maintain sterility?

  The Mecta-C and Mecta-C TiPEEK devices are explicitly designed for single-use only. They are supplied sterile, so they should remain in their original packaging until immediately before use. Once opened or used, they must be discarded to prevent contamination and ensure patient safety. Proper sterile handling is essential to avoid compromising the device’s integrity or introducing infection risks.

• What cervical spine levels can these devices be used for, and why is supplemental spinal fixation required?

  These devices are approved for cervical spine fusion procedures from C2 to T1. Supplemental spinal fixation (e.g., screws, rods, or plates) is required because the Mecta-C and Mecta-C TiPEEK devices are intervertebral fusion cages—they provide structural support and bone-graft containment but rely on additional fixation to ensure proper stabilization and alignment of the spine during the fusion process.

• How do the titanium markers in these devices benefit clinicians during surgery?

  The integrated titanium markers in both the Mecta-C and Mecta-C TiPEEK devices improve radiographic visibility under X-ray or fluoroscopy. This helps clinicians visualize the device’s position intraoperatively and postoperatively, ensuring accurate placement, alignment, and monitoring of spinal fusion progress. Clear imaging is particularly important in cervical spine procedures where precision is critical.

• What regulatory pathway was followed for FDA clearance of these devices, and what does ‘substantially equivalent’ mean in this context?

  The Mecta-C and Mecta-C TiPEEK devices received FDA 510(k) clearance under the Orthopedic (OR) advisory committee, with a decision code of SESE (Substantially Equivalent, Special). This means the FDA determined they are substantially equivalent to a legally marketed predicate device in terms of technology, performance, and intended use. The ‘special’ classification indicates a more detailed review was conducted, ensuring safety and effectiveness comparable to existing spinal fusion devices.