Synthes Spine Small Stature Anterior Cervical Vertebrae Plate System

• • Terminated Z-1524-2016 FDA Class II ·initiated 6 Jan 2016

  DePuy Synthes is initiating a Voluntary Medical Device Recall of lot # 9666776 and 9671879 of Cancellous and Cortex 4.0 mm Screws, which are a part of the Cervical Spine Locking Plate (CSLP) System due to discovery of a single lot of 450.136 screws (4mm Cancellous Self Tapping Screw, Length 16mm, lot 9666776) being swapped with a single lot of 450.016 (4mm Cortex Standard Screw, length 16 mm, lot 9671879).

510(k) Number

K971883 ↗

FDA Product Code

KWQ

Device Class

Class II

Regulation

21 CFR Part 888.3060

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 types of screws are included in the Synthes Spine Small Stature Anterior Cervical Vertebrae Plate System, and how do they differ in function?

  The system includes three types of screws: cancellous screws, designed for use in spongy bone; cortical screws, intended for denser bone; and expansion-type screws with locking mechanisms, which provide additional stability by expanding within the bone. These variations allow surgeons to select the appropriate screw type based on the patient’s bone density and fixation requirements.

• Is this device compatible with MRI imaging, and why is that important for patients?

  Yes, the Synthes Spine Small Stature Anterior Cervical Vertebrae Plate System is designed with components compatible with MRI safety standards. This is important because it allows patients to undergo MRI scans post-surgery without the risk of imaging artifacts or complications, ensuring long-term monitoring and follow-up flexibility.

• How is the device supplied, and what preparation is required before use in the operating room?

  The system is supplied as a reusable device and is not sterile at the time of shipment. It must be sterilized prior to use, following standard medical device sterilization protocols (e.g., autoclave or ethylene oxide). Clinicians should confirm compatibility with their facility’s sterilization methods before use.

• What makes this system specifically tailored for patients with smaller statures?

  The plates and screws in this system are designed with sizes tailored for small stature patients, ensuring proper alignment and fixation in cervical vertebrae of shorter individuals. This distinction helps prevent over-sizing issues that could compromise stability or lead to discomfort.

• How was the FDA clearance for this device determined, and what does ‘Substantially Equivalent’ mean in this context?

  The device received FDA clearance under the 510(k) Traditional Review pathway, classified as *Substantially Equivalent (SESE)* to a predicate device. This means the FDA determined that the Synthes Spine Small Stature system has the same intended use and technological characteristics as a previously cleared orthopedic cervical fixation device, meeting safety and effectiveness standards without requiring a full PMA approval.