SDB Cerclage System

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

510(k) Number

K992616 ↗

FDA product code

JDQ

Device class

Class II

Regulation

21 CFR Part 888.3010

Advisory committee

Orthopedic

FDA decision

SESE Substantially Equivalent

• Pacp

  Class II

  FDA 510(k) K083663 Active Cleared 25 Feb 2009

• Modification to: Pioneer Surgical Technology Quantum Spinal System

  Class II

  FDA 510(k) K070551 Active Cleared 29 Mar 2007

• Tritium Sternal Cable Plate System

  Class II

  FDA 510(k) K193468 Active Cleared 12 Mar 2020

• Pioneer Vertebral Spacer (Vertebral Spacer)

  Class II

  FDA 510(k) K061151 Active Cleared 24 Jul 2006

• Quantum/ Streamline Spinal System Model 02-Series and 10-Series

  Class II

  FDA 510(k) K093692 Active Cleared 11 Aug 2010

• Quantum/Streamline Tl Mis Spinal System

  Class II

  FDA 510(k) K093771 Active Cleared 10 Aug 2010

See all devices from Pioneer Surgical Technology, Inc. →

• What types of orthopedic procedures is the SDB Cerclage System intended for, and how does it work?

  The SDB Cerclage System is designed for internal fixation in orthopedic procedures where bone fragments or joints need stabilization. It works by encircling and securing the surgical site with tensioned cable constructs, effectively holding bone fragments together to promote proper healing. This is particularly useful in fracture fixation or joint stabilization scenarios.

• What cable sizes are available in the SDB Cerclage System, and how does this affect its use?

  The SDB Cerclage System is supplied in two distinct cable sizes, which allows for flexibility in addressing different clinical scenarios. The specific sizes are not detailed in the data, but the availability of multiple sizes suggests it can accommodate varying bone diameters or fracture patterns, ensuring a secure and tailored fit for the surgical site.

• Is the SDB Cerclage System intended for single-use or can it be reused after sterilization?

  The provided data does not explicitly state whether the SDB Cerclage System is single-use or reusable. Without clear sterility specifications or reuse instructions, clinicians should follow established hospital protocols for device reprocessing if reuse is considered. It is critical to ensure proper sterilization and maintenance to prevent contamination or compromise of device integrity.

• How was the FDA clearance for the SDB Cerclage System determined, and what does this mean for its regulatory status?

  The SDB Cerclage System received a traditional 510(k) clearance (K992616) in 1999, with the FDA determining it to be *substantially equivalent* to a legally marketed device in the orthopedic category. This means the FDA reviewed it against a predicate device and found it to have the same intended use, technological characteristics, and performance as that predicate. The clearance does not imply ongoing approval but confirms compliance with FDA requirements at the time of submission.