Cleared Traditional

K141695 - ACROSSPINE PEDICLE SCREW SYSTEM

K141695 is an FDA 510(k) clearance for ACROSSPINE PEDICLE SCREW SYSTEM, manufactured by Arthro-Dif. The device is a Class 2 Orthopedic device with product code NKB cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K141695 · Arthro-Dif · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2014
Decision
189d
Days
Class 2
Risk

K141695 is an FDA 510(k) clearance for the ACROSSPINE 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 Arthro-Dif (Fr. Myers, US). The FDA issued a Cleared decision on December 30, 2014 after a review of 189 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 Arthro-Dif devices

FDA 510(k) Submission Details - K141695

510(k) Number K141695 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 2014
Decision Date December 30, 2014
Days to Decision 189 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
67d slower than avg
Panel avg: 122d · This submission: 189d
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 731
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K141695.
Range/Denali/Mesa Spinal System
K143334 · K2m, Inc. · Jan 2015
Arsenal Spinal Fixation System
K143149 · Alphatec Spine, Inc. · Jan 2015
FIREBIRD SPINAL FIXATION SYSTEM
K141186 · Orthofix, Inc. · Jan 2015
Reform Pedicle Screw System
K143248 · Precision Spine, Inc. · Dec 2014
MAS PLIF Fixation system
K142737 · Nu Vasive, Incorporated · Dec 2014
Threshold Pedicular Fixation System
K143403 · Spineology, Inc. · Dec 2014