UniVise Spinous Process Fixation Plate (35MM, 40MM)

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

510(k) Number

K132968 ↗

FDA Product Code

PEK

Device Class

Class II

Regulation

21 CFR Part 888.3050

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• 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

• XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato® Spinal System, XIA® Growth Rod Conversion Set, XIA® II Spinal System, XIA® Precision System, XIA® Anterior, Diapason® Spinal System, Opus™ Spinal System, Radius® Spinal System, Mantis® Spinal System, Mantis® Redux, Trio® & Trio+ Spinal Fixation System, ES2™ Spinal System, ES2™ Augmentable Spinal System, Oasys® Occipito-Cervico-Thoracic System, Nile® Proximal Fixation Spinal System, Nile® Alternative Fi

  Class II

  FDA 510(k) K222684 Active Cleared 8 Jun 2023

• Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal Fixation Systems, and Trio Trauma Spinal

  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 is the primary purpose of the UniVise Spinous Process Fixation Plate, and where is it used in the body?

  The UniVise Spinous Process Fixation Plate is designed for posterior non-cervical spine fixation, specifically to provide supplemental stabilization at a single level from the first thoracic vertebra (T1) down to the sacrum (S1). It attaches to adjacent spinous processes—bony projections at the back of the vertebrae—without requiring engagement with the pedicles, making it suitable for procedures where pedicle screws may not be ideal.

• How is the UniVise Spinous Process Fixation Plate supplied, and is it reusable?

  The UniVise Spinous Process Fixation Plate is supplied as a sterile, single-use implant, meaning it is intended for one-time surgical use only. Reuse is not recommended or supported by the manufacturer, as sterility and performance may be compromised after a single application.

• What are the available sizes for the UniVise Spinous Process Fixation Plate, and how does this affect its application?

  The UniVise Spinous Process Fixation Plate is available in two widths: 35mm and 40mm. The width determines the spacing between the spinous processes it can secure, allowing surgeons to select the appropriate size based on the patient’s anatomy and the specific surgical requirements for stabilization.

• How should the UniVise Spinous Process Fixation Plate be stored, and what precautions should be taken?

  The plate must be stored and handled according to sterile surgical instrument protocols to maintain its sterility. Since it is intended for single-use in the operating room, it should be kept in its original packaging until immediately before use, protected from contamination, moisture, and physical damage.

• What regulatory pathway was followed for FDA clearance of the UniVise Spinous Process Fixation Plate?

  The UniVise Spinous Process Fixation Plate received FDA 510(k) clearance through a traditional review process, determined to be *substantially equivalent* to a legally marketed predicate device. The clearance was granted under the Orthopedic (OR) Advisory Committee and classified as a Class II medical device, reflecting its moderate risk level.