Cleared Traditional

4CIS SARA Spine System, 4CIS VERTU Spine System (K202498) - FDA 510(k) Clearance

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

K202498 · Solco Biomedical Company India Private Limited · Orthopedic device
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Feb 2021
Decision
171d
Days
Class 2
Risk

K202498 is an FDA 510(k) clearance for the 4CIS SARA Spine System, 4CIS VERTU Spine System. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Solco Biomedical Company India Private Limited (Village-Rajpur, IN). The FDA issued a Cleared decision on February 18, 2021 after a review of 171 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 Solco Biomedical Company India Private Limited devices

Submission Details

510(k) Number K202498 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 2020
Decision Date February 18, 2021
Days to Decision 171 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
49d slower than avg
Panel avg: 122d · This submission: 171d
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 K202498.
CarboClear X Pedicle Screw System, CarboClear X Navigated Instruments
K210716 · CarboFix Orthopedics , Ltd. · Apr 2021
Polaris Spinal System
K210275 · Zimmer Biomet Spine, Inc. · Apr 2021
Republic Spine Dark Star Spinal System
K201420 · Republic Spine, LLC · Mar 2021
Vitality® Spinal Fixation System
K203507 · Zimmer Biomet Spine, Inc. · Jan 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