Cleared Traditional

K123939 - S4 SPINAL SYSTEM

K123939 is an FDA 510(k) clearance for S4 SPINAL SYSTEM, manufactured by Aesculap Implant Systems, Inc.. The device is a Class 2 Orthopedic device with product code NKB cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K123939 · Aesculap Implant Systems, Inc. · Orthopedic device
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Mar 2013
Decision
82d
Days
Class 2
Risk

K123939 is an FDA 510(k) clearance for the S4 SPINAL SYSTEM. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Aesculap Implant Systems, Inc. (Center Valley, US). The FDA issued a Cleared decision on March 12, 2013 after a review of 82 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 Aesculap Implant Systems, Inc. devices

FDA 510(k) Submission Details - K123939

510(k) Number K123939 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 2012
Decision Date March 12, 2013
Days to Decision 82 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
40d faster than avg
Panel avg: 122d · This submission: 82d
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 715
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K123939.
SOLANAS POSTERIOR STABILIZATION SYSTEM
K131119 · Alphatec Spine, Inc. · May 2013
CD HORIZON SPINAL SYSTEM
K130646 · Medtronic Sofamor Danek USA, Inc. · Apr 2013
STREAMLINE MIS SPINAL FIXATION SYSTEM
K130286 · Pioneer Surgical Technology, Inc. · Apr 2013
NAUTILUS SPINAL SYSTEM
K123373 · Life Spine · Mar 2013
UCENTUM
K123717 · Ulrich GmbH & Co. KG · Mar 2013
CD HORIZON SPINAL SYSTEM
K123809 · Medtronic Sofamor Danek USA, Inc. · Feb 2013