Cleared Traditional

K100623 - AESCULAP IMPLANT SYSTEMS S4 SPINAL SYSTEM

K100623 is an FDA 510(k) clearance for AESCULAP IMPLANT SYSTEMS S4 SPINAL SYSTEM, manufactured by Aesculap Implant Systems. The device is a Class 2 Orthopedic device with product code NKB cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K100623 · Aesculap Implant Systems · Orthopedic device
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Jun 2010
Decision
97d
Days
Class 2
Risk

K100623 is an FDA 510(k) clearance for the AESCULAP IMPLANT SYSTEMS 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 (Center Valley, US). The FDA issued a Cleared decision on June 9, 2010 after a review of 97 days - within the typical 510(k) review window.

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 Aesculap Implant Systems devices

FDA 510(k) Submission Details - K100623

510(k) Number K100623 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 2010
Decision Date June 09, 2010
Days to Decision 97 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
25d faster than avg
Panel avg: 122d · This submission: 97d
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 K100623.
TILOCK PEDICLE SCREW SYSTEM
K100757 · Genesys Spine · Jul 2010
POLARIS SPINAL SYSTEM, POLARIS/SYNERGY STRUCTURE ANTERIOR FIXATION SYSTEM
K100438 · Ebi, L.P. · Jun 2010
MODIFICATION TO: CD HORIZON(R) SPINAL SYSTEM
K101074 · Medtronic Sofamor Danek USA, Inc. · Jun 2010
POLARIS SPINAL SYSTEM
K100220 · Ebi, L.P. · May 2010
COCR RODS
K100788 · Globus Medical, Inc. · May 2010
TSRH SPINAL SYSTEM
K091797 · Medtronic Sofamor Danek · Apr 2010