VertiForm Posterior Fixation System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K161499 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 VertiForm Posterior Fixation System is a spinal fixation device classified as a pedicle screw fixation system (product code NKB). It provides posterior, non-cervical stabilization of the spine in skeletally mature patients by securing pedicle screws, rods, and variable cross connectors to address degenerative, traumatic, or structural spinal pathologies.
This system is intended for surgical use in clinical settings and consists of polyaxial, fixed, or uniplanar pedicle screws, set screws, rods, and cross connectors. The components are designed for single-use and are regulated under an FDA 510(k) clearance (K161499) as substantially equivalent to a predicate device. Sterility and packaging details are not specified in the available data.
Frequently asked questions
What types of spinal conditions is the VertiForm Posterior Fixation System designed to address in skeletally mature patients?
The VertiForm Posterior Fixation System is intended for posterior, non-cervical stabilization of the spine in skeletally mature patients. It is designed to address degenerative, traumatic, or structural spinal pathologies by securing pedicle screws, rods, and variable cross connectors to provide stability.
Is the VertiForm Posterior Fixation System reusable or intended for single-use?
The VertiForm Posterior Fixation System is explicitly designed for single-use, as stated in the device description. This aligns with common practices in spinal fixation to ensure sterility and reduce infection risks.
How is the VertiForm Posterior Fixation System regulated in the U.S.?
The VertiForm Posterior Fixation System holds an FDA 510(k) clearance (K161499) and is classified under product code NKB as a pedicle screw fixation system. It was determined to be substantially equivalent to a predicate device through a special review process by the Orthopedic (OR) Advisory Committee.
What components does the VertiForm Posterior Fixation System include?
The system includes polyaxial, fixed, or uniplanar pedicle screws, set screws, rods, and variable cross connectors. These components work together to provide adjustable and secure posterior spinal stabilization.
What kind of spinal regions does the VertiForm Posterior Fixation System target?
The VertiForm Posterior Fixation System is specifically designed for non-cervical regions of the spine, meaning it is not intended for use in the cervical (neck) area but rather for thoracic, lumbar, or sacral stabilization.
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: VertiForm Posterior Fixation System by NEXT ORTHOSURGICAL | FDA 510 (k ..., VertiForm Posterior Fixation System (K161499) — FDA 510 (k) | Innolitics, VERTIFORM POSTERIOR FIXATION SYSTEM 510(k) K141291 - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K161499 | Class II | Active |
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Manufacturer
- Manufacturer
- Next Orthosurgical
Sources (1)
- FDA 510(k) K161499 24 fields · synced Sep 19, 2026