Cleared Traditional

RIVA Posterior Fixation System (K251154) - FDA 510(k) Clearance

Also marketed or referenced as:
RIVA Posterior Fixation System Navigation Instruments

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

K251154 · Ht Medical D.B.A. Xenix Medical · Orthopedic device
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Optimized for regulatory review, auditing and printing
Jun 2025
Decision
59d
Days
Class 2
Risk

K251154 is an FDA 510(k) clearance for the RIVA Posterior 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 Ht Medical D.B.A. Xenix Medical (Orlando, US). The FDA issued a Cleared decision on June 12, 2025 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 Ht Medical D.B.A. Xenix Medical devices

Submission Details

510(k) Number K251154 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 2025
Decision Date June 12, 2025
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 K251154.
KHEIRON® Spinal Fixation System, including patient specific K-ROD
K251804 · S.M.A.I.O · Jul 2025
Momentum® Posterior Spinal Fixation System
K251719 · Ulrich Medical USA, Inc. · Jul 2025
Virata Spinal Fixation System
K250908 · SeaSpine Orthopedics Corporation · Jun 2025
Annex® 2 Adjacent Level System
K251131 · Spine Wave, Inc. · Jun 2025
COLONNADE Posterior Screw Fixation System
K250582 · CG Bio Co., Ltd. · May 2025
Eminent Spine 3D Titanium Pedicle Screw System
K241663 · Eminent Spine · Apr 2025