Identifiers
- 510(k) Number
- K140802 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 Pedicle Screw System is a fenestrated pedicle screw designed for posterior spinal fixation. It features a cortical-trajectory thread profile intended for cement augmentation, enabling secure fixation in spinal procedures. This device is classified under product code NKB and is intended for use in orthopedic spinal applications. The system is engineered to support open, minimally invasive surgery (MIS), or percutaneous techniques, providing versatility in surgical approaches.
The SteriSpine PS is supplied as a single-use, sterile device with ready-to-use instruments, ensuring traceability and reducing cross-contamination risks. It is regulated under FDA 510(k) clearance (K140802) with a Special review classification, determined by the Orthopaedic Devices Advisory Committee. The device is intended for use in spinal fixation procedures and is not MRI-safe. Storage and handling must comply with sterile medical device protocols to maintain integrity.
Frequently asked questions
What is the SteriSpine PS Pedicle Screw System designed for?
The SteriSpine PS Pedicle Screw System is specifically designed for posterior spinal fixation in orthopedic procedures. Its fenestrated design and cortical-trajectory thread profile are optimized for cement augmentation, providing enhanced fixation stability during surgery. This versatility allows it to be used in open, minimally invasive surgery (MIS), or percutaneous techniques, making it adaptable to various surgical approaches.
Is the SteriSpine PS Pedicle Screw System single-use or reusable?
The SteriSpine PS Pedicle Screw System is supplied as a single-use device. This design choice ensures traceability and minimizes the risk of cross-contamination, which is critical in sterile surgical environments. Single-use also simplifies inventory management and reduces the need for reprocessing.
How should the SteriSpine PS Pedicle Screw System be stored?
The SteriSpine PS Pedicle Screw System must be stored and handled according to sterile medical device protocols to maintain its integrity. Proper storage conditions are essential to preserve sterility and functionality, as the device is supplied in a sterile package ready for immediate use. Always follow manufacturer guidelines for unpacking and preparation to ensure optimal performance.
What surgical approaches can the SteriSpine PS Pedicle Screw System be used with?
The SteriSpine PS Pedicle Screw System is engineered to support three primary surgical approaches: open surgery, minimally invasive surgery (MIS), and percutaneous techniques. Its design accommodates the varying requirements of these approaches, providing flexibility for surgeons to choose the method that best suits the clinical case while maintaining secure fixation.
Is the SteriSpine PS Pedicle Screw System MRI-safe?
No, the SteriSpine PS Pedicle Screw System is not MRI-safe. This limitation is important for clinicians to consider when planning postoperative imaging or follow-up care, as MRI scans could potentially affect the device or produce inaccurate results. Always verify compatibility with imaging modalities before scheduling scans.
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, SteriSpine PS - SPINEMarketGroup, Safe Orthopaedics: Efficacy of the Next-generation SteriSpine PS ..., Safe Orthopaedics - SPINEMarketGroup
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K140802 | Class II | Active |
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Manufacturer
- Manufacturer
- Safe Orthopaedics
Sources (1)
- FDA 510(k) K140802 24 fields · synced Oct 1, 2026