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SteriSpine PS

FDA 510(k)FDA UDI

Class II (US FDA 510(k))

510(k) K151921

by Safe Orthopaedics

Identity

Trade Name
STERISPINE PS FDA UDI
Generic Name
Spinal bone screw, non-bioabsorbable FDA UDI
Model / Reference
KITACL725 FDA UDI

Identifiers

Primary DI / UDI-DI
03760219919551 FDA UDI
510(k) Number
K151921 FDA 510(k)FDA UDI
FDA Product Code
NKB FDA 510(k)FDA UDI
GMDN Term
Spinal bone screw, non-bioabsorbable FDA UDI

Classification

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

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

The SteriSpine PS is a single-use pedicle screw system designed for spinal fixation. It is classified under the nomenclature category NKB (Orthopedic Device: Spinal Fixation Device) and is intended for use in open, minimally invasive surgery (MIS), or percutaneous procedures to stabilize vertebrae.

This system is supplied sterile and includes ready-to-use, single-use instruments. It is regulated under FDA 510K clearance (K151921) and is intended for use in orthopedic spinal surgery applications. The SteriSpine PS was developed to enhance surgical flexibility and traceability, ensuring compatibility with various surgical approaches and augmentations.

Frequently asked questions

What types of surgical procedures is the SteriSpine PS system designed for, and how does it differ from traditional pedicle screw systems in terms of approach?

The SteriSpine PS is specifically designed for spinal fixation in open, minimally invasive surgery (MIS), or percutaneous procedures, offering flexibility across different surgical approaches. Unlike traditional systems, it is engineered to enhance adaptability for these varied techniques while maintaining compatibility with augmentations. This versatility makes it suitable for surgeons who need a single-use solution that can be applied in both open and minimally invasive contexts without compromising stability or precision.

Is the SteriSpine PS system single-use, and if so, what does this mean for surgical workflow and cost efficiency?

Yes, the SteriSpine PS is a single-use system, meaning each component—including screws and instruments—is intended for one surgical procedure only. This design eliminates the need for sterilization between cases, reducing surgical workflow interruptions and potential contamination risks. While it may require purchasing multiple kits for repeated procedures, the sterile, ready-to-use nature simplifies inventory management and ensures consistent performance without reprocessing steps.

How is the SteriSpine PS system supplied, and what should clinicians expect in terms of sterility and packaging?

The SteriSpine PS is supplied sterile, meaning it is pre-sterilized and packaged to maintain sterility until use. The system includes ready-to-use, single-use instruments alongside the screws, ensuring no additional sterilization is required in the operating room. Clinicians can expect a sealed, sterile package designed for immediate surgical use, reducing preparation time and ensuring compliance with infection control protocols.

What regulatory pathway was followed for FDA clearance of the SteriSpine PS, and what does this mean for clinicians using the device?

The SteriSpine PS received FDA 510K clearance (K151921) under the Traditional 510(k) pathway, with a decision classification of Substantially Equivalent (SESE) to a predicate device. This means the FDA determined it has the same intended use and technological characteristics as a previously cleared device, ensuring it meets regulatory standards for safety and effectiveness. Clinicians can rely on this clearance as evidence of the device’s compliance with FDA requirements for spinal fixation systems.

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 (2)

  • FDA 510(k) K151921 24 fields · synced Sep 19, 2026
  • FDA UDI c506569f-41c4-41f0-a0e7-fe467c8a1780 33 fields · synced May 27, 2026