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Vector Pedicle Screw System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K241276

by Innovasis, Inc.

Identifiers

510(k) Number
K241276 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 Vector Pedicle Screw System is a spinal fixation device classified as a Pedicle Screw System (Product Code NKB) under FDA nomenclature. It is designed for posterior spinal stabilization, providing immobilization of spinal segments via pedicle or non-pedicle screw fixation in skeletally mature patients as an adjunct to spinal fusion procedures.

This system is intended for use in the thoracic, lumbar, and sacral spine to address acute and chronic instabilities or deformities, including degenerative disc disease. Supplied as a reusable surgical instrument set, it requires sterile handling and is regulated under FDA 510(k) clearance (K241276) with a decision of Substantially Equivalent (SESE). No specific MRI safety classification or single-use designation is noted in the available data.

Frequently asked questions

What types of spinal conditions is the Vector Pedicle Screw System intended to address, and where along the spine can it be used?

The Vector Pedicle Screw System is designed for posterior spinal stabilization to address acute or chronic instabilities and deformities in skeletally mature patients. It is specifically intended for use in the thoracic, lumbar, and sacral regions of the spine, often as an adjunct to spinal fusion procedures. This includes conditions like degenerative disc disease, but it is not meant for pediatric or non-skeletally mature patients.

Is the Vector Pedicle Screw System reusable or single-use, and how should it be handled during surgery?

The Vector Pedicle Screw System is supplied as a reusable surgical instrument set, meaning it is intended for multiple uses in different procedures. Since it is reusable, strict sterile handling protocols must be followed to ensure patient safety, including proper cleaning, sterilization, and storage between uses.

What regulatory pathway was followed for FDA clearance of the Vector Pedicle Screw System, and what does this mean for its use?

The Vector Pedicle Screw System received FDA clearance through a Traditional 510(k) pathway, specifically under the Orthopedic Advisory Committee (OR). The decision was marked as Substantially Equivalent (SESE), meaning the device was determined to be as safe and effective as a legally marketed predicate device. This clearance allows for its use in the specified indications under the conditions outlined in the FDA submission.

Are there any specific storage requirements for the Vector Pedicle Screw System, and does it have any special considerations for MRI safety?

The available data does not specify any unique storage requirements beyond standard surgical instrument care for a reusable system. Additionally, there is no mention of an MRI safety classification for the Vector Pedicle Screw System, so its compatibility with MRI should be verified on a case-by-case basis or per manufacturer guidelines, as metallic implants can pose risks in MRI environments.

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: Vector™ Pedicle Screw System (K241276) — FDA 510(k) | Innolitics, Class 2 Device Recall Vector Pedicle Screw System, Innovasis, Inc — Z-2859-2026 · DeviceClearance, Vector? Pedicle Screw System 510 (k) K241276 - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Innovasis, Inc.

Sources (1)

  • FDA 510(k) K241276 24 fields · synced Sep 19, 2026