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SteriSpinePS Pedicle Screw

FDA 510(k)

Class II (US FDA 510(k))

510(k) K112453

by Safe Orthopaedics

Identifiers

510(k) Number
K112453 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 SteriSpinePS Pedicle Screw is a single-use orthopedic fixation device designed for spinal stabilization. Classified as a pedicle screw under the NKB product code, it is intended for securing spinal rods in spinal fusion procedures, providing secure anchorage within the vertebral pedicles.

Supplied sterile and pre-calibrated, this device is intended for one-time use to minimize contamination risks. Authorized under FDA 510(k) clearance (K112453) as substantially equivalent to existing orthopedic pedicle screws, it is regulated as a Class II medical device. Storage and handling must adhere to sterile surgical protocols to ensure integrity before use.

Frequently asked questions

What types of spinal procedures is the SteriSpinePS Pedicle Screw intended for use in?

The SteriSpinePS Pedicle Screw is specifically designed for spinal fusion procedures where secure spinal stabilization is required. It is intended to anchor spinal rods within the vertebral pedicles, ensuring stable fixation during reconstructive or corrective surgeries of the spine.

Is the SteriSpinePS Pedicle Screw meant for single-use or can it be reused?

The SteriSpinePS Pedicle Screw is explicitly designed for single-use only to minimize contamination risks. It is supplied sterile and pre-calibrated, adhering to surgical best practices for sterile instruments.

How should the SteriSpinePS Pedicle Screw be stored before use?

Since it is a sterile device, the SteriSpinePS Pedicle Screw must be stored and handled according to sterile surgical protocols to maintain its integrity. This includes keeping it in its original packaging until immediately before use, following standard operating room procedures.

What regulatory pathway was followed for FDA clearance of this device?

The SteriSpinePS Pedicle Screw received FDA clearance through an Abbreviated 510(k) pathway (K112453), demonstrating substantial equivalence to existing orthopedic pedicle screws. The review was conducted by the Orthopedic (OR) Advisory Committee, confirming compliance with Class II medical device regulations.

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, SteriSpine PS - SPINEMarketGroup, PDF SteriSpine PS Pedcli e Screw System TM mSi ply Smart

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Safe Orthopaedics

Sources (1)

  • FDA 510(k) K112453 24 fields · synced Sep 19, 2026