Cleared Traditional

Vital™ Spinal Fixation System (K230116) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K230116 · Zimvie Spine (Zimmer Biomet Spine, Inc.) · Orthopedic device
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Oct 2023
Decision
267d
Days
Class 2
Risk

K230116 is an FDA 510(k) clearance for the Vital™ Spinal Fixation System. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Zimvie Spine (Zimmer Biomet Spine, Inc.) (Westminister, US). The FDA issued a Cleared decision on October 11, 2023 after a review of 267 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Zimvie Spine (Zimmer Biomet Spine, Inc.) devices

Submission Details

510(k) Number K230116 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 2023
Decision Date October 11, 2023
Days to Decision 267 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
145d slower than avg
Panel avg: 122d · This submission: 267d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NKB Thoracolumbosacral Pedicle Screw System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
Definition Intended To Provide Immobilization And Stabilization Of Spinal Segments In Thoracic, Lumbar, And Sacral Spine As An Adjunct To Fusion.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - NKB Thoracolumbosacral Pedicle Screw System

All 447
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K230116.
Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal System
K232586 · K&J Consulting Corp. · Oct 2023
Ripley Spinal Screw System by SAGICO
K232561 · Sagico VA USA, LLC · Oct 2023
VyLink™ Spinal Screw System
K231744 · Vy Spine, LLC · Oct 2023
Zeus Spinal System
K230961 · Shanghai Sanyou Medical Co, Ltd. · Oct 2023
VEOS Spinal Fixation System
K231658 · Spineway · Oct 2023
CarboClear® Pedicle Screw System
K232341 · CarboFix Orthopedics , Ltd. · Oct 2023