Cleared Traditional

Vitality® Spinal Fixation System (K203507) - FDA 510(k) Clearance

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

K203507 · Zimmer Biomet Spine, Inc. · Orthopedic device
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Jan 2021
Decision
59d
Days
Class 2
Risk

K203507 is an FDA 510(k) clearance for the Vitality® 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 Zimmer Biomet Spine, Inc. (Westminister, US). The FDA issued a Cleared decision on January 28, 2021 after a review of 59 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Zimmer Biomet Spine, Inc. devices

Submission Details

510(k) Number K203507 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 2020
Decision Date January 28, 2021
Days to Decision 59 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 122d · This submission: 59d
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 K203507.
Polaris Spinal System
K210275 · Zimmer Biomet Spine, Inc. · Apr 2021
Republic Spine Dark Star Spinal System
K201420 · Republic Spine, LLC · Mar 2021
4CIS SARA Spine System, 4CIS VERTU Spine System
K202498 · Solco Biomedical Company India Private Limited · Feb 2021
Altus Spine HA Pedicle Screw System
K200922 · Altus Partners, LLC · Jan 2021
M.U.S.T. Pedicle Screw Extension and Long Tab Implants
K203482 · Medacta International S.A. · Jan 2021
CREO Stabilization System, Navigation Instruments, ExcelsiusGPS
K203153 · Globus Medical, Inc. · Jan 2021