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Sterispine PS

FDA 510(k)

Class II (US FDA 510(k))

510(k) K201648

by Safe Orthopaedics

Identifiers

510(k) Number
K201648 FDA 510(k)
FDA Product Code
NKB FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3070 FDA 510(k)
Regulation Number
888.3070 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Sterispine PS is a pedicle screw system designed for spinal fixation, classified under the orthopedic device nomenclature for spinal instrumentation. It features cannulated, fenestrated screws and pre-assembled instrumentation, enabling versatile surgical approaches including open, minimally invasive (MIS), and percutaneous techniques. The system is engineered to facilitate screw augmentation with bone cement when required, enhancing fixation stability in spinal pathologies. Its modular design supports adaptability to varying clinical scenarios while maintaining surgical precision.

The Sterispine PS is supplied as a single-use, sterile system, including ready-to-use instruments, ensuring full traceability and reducing contamination risks. It is intended for use in orthopedic settings with MRI-unspecified components, adhering to standard surgical sterility protocols. The system is available in configurations compatible with cannulated screw techniques, though specific sizes or variants are not detailed in the regulatory data. Authorized under FDA 510K clearance (K201648) as substantially equivalent to prior-generation devices, it complies with orthopedic submission standards without additional regulatory markings in the provided context.

Frequently asked questions

What types of surgical approaches can the Sterispine PS system support, and why is this important for clinicians?

The Sterispine PS is designed to support open, minimally invasive (MIS), and percutaneous surgical approaches, offering flexibility depending on the clinical scenario. This versatility is important because it allows surgeons to choose the least invasive technique that best suits the patient’s anatomy and pathology, potentially reducing recovery time and complications while maintaining precise fixation.

Is the Sterispine PS system intended for reuse, or is it meant to be used only once per patient? How does this affect infection control?

The Sterispine PS is explicitly supplied as a single-use, sterile system, which eliminates the need for reprocessing and significantly reduces the risk of surgical site infections. This aligns with modern infection control protocols, ensuring traceability and minimizing contamination risks associated with reusable devices.

Does the Sterispine PS system include any special features to improve fixation stability in challenging spinal cases?

Yes, the Sterispine PS system is engineered with cannulated and fenestrated screws, allowing for augmentation with bone cement when needed. This feature enhances fixation stability in cases involving poor bone quality or high-risk scenarios, such as revision surgeries or osteoporotic patients.

What storage requirements should be followed for the Sterispine PS system to maintain sterility?

Since the Sterispine PS is a sterile, single-use system, it should be stored in its original packaging until ready for use, following standard surgical sterility protocols. The packaging is designed to protect against contamination, so it must remain unopened and undamaged until the procedure begins.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: safe-orthopaedics, Safe Orthopaedics: Efficacy of the Next-generation SteriSpine PS ..., SteriSpine PS - SPINEMarketGroup

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Safe Orthopaedics

Sources (1)

  • FDA 510(k) K201648 24 fields · synced Sep 20, 2026