USS VAS

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K002517 ↗

FDA Product Code

KWP

Device Class

Class II

Regulation

21 CFR Part 888.3050

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Synthes Light Guide

  Class II

  FDA 510(k) K993314 Active Cleared 6 Dec 1999

• Synthes Locking Hand Plates

  Class II

  FDA 510(k) K092247 Active Cleared 25 Sep 2009

• Synthes Matrix Mis Rods

  Class II

  FDA 510(k) K093668 Active Cleared 9 Mar 2010

• Synthes Lcp Proximal Tibia Plate

  Class II

  FDA 510(k) K011978 Active Cleared 9 Aug 2001

• Synthes Locking Calcaneal Plates

  Class II

  FDA 510(k) K991407 Active Cleared 11 Jun 1999

• Volar Distal Radius Plate

  Class II

  FDA 510(k) K953644 Active Cleared 8 Mar 1996

See all devices from Synthes (Usa) →

• What specific spinal condition is the USS VAS designed to address, and how does it achieve stabilization?

  The USS VAS is specifically designed to stabilize the spine in skeletally mature patients with severe spondylolisthesis at the L5-S1 vertebra. It achieves stabilization through surgical fixation, providing structural support to prevent slippage and promote proper alignment during the healing process.

• Is the USS VAS intended for single-use or reusable applications in the operating room?

  The USS VAS is supplied as a reusable medical instrument, meaning it is intended for repeated use in surgical settings after proper cleaning, sterilization, and maintenance. This design aligns with its classification as an orthopedic appliance for spinal procedures.

• How is the USS VAS regulated by the FDA, and what does the 'Substantially Equivalent' determination mean in this context?

  The USS VAS is regulated under the FDA’s 510(k) clearance process (K002517) and received a Substantially Equivalent (SESE) determination through the Traditional review pathway. This means the FDA concluded that the device is at least as safe and effective as a legally marketed predicate device (a previously cleared spinal fixation appliance) and meets Class II – Special Controls standards for orthopedic devices.

• What type of surgical setting or specialty is the USS VAS intended for, and why?

  The USS VAS is intended for use in orthopedic surgical settings, specifically for procedures addressing severe spondylolisthesis at L5-S1. Its classification as an Appliance, Fixation, Spinal Interlaminal (product code KWP) and its design for spinal stabilization align it with orthopedic spine surgery applications.