Cleared Traditional

K252139 - Kentrospine Viktr-MIS® Pedicle screw system

K252139 is an FDA 510(k) clearance for Kentrospine Viktr-MIS Pedicle screw system, manufactured by Rivarp Medical Pvt., Ltd.. The device is a Class 2 Orthopedic device with product code NKB cleared through the Traditional 510(k) pathway after a 446-day FDA review.

K252139 · Rivarp Medical Pvt., Ltd. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Sep 2026
Decision
446d
Days
Class 2
Risk

K252139 is an FDA 510(k) clearance for the Kentrospine Viktr-MIS® Pedicle screw system. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Rivarp Medical Pvt., Ltd. (Bangalore, IN). The FDA issued a Cleared decision on September 27, 2026 after a review of 446 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Rivarp Medical Pvt., Ltd. devices

FDA 510(k) Submission Details - K252139

510(k) Number K252139 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 2025
Decision Date September 27, 2026
Days to Decision 446 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
324d slower than avg
Panel avg: 122d · This submission: 446d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NKB Device Classification - Class 2, Special Controls

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 913
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