Cleared Traditional

S4 CERVICAL OCCIPITAL PLATE SPINAL SYSTEM (K062012) - FDA 510(k) Clearance

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

K062012 · Aesculap, Inc. · Orthopedic device
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Feb 2007
Decision
207d
Days
Class 2
Risk

K062012 is an FDA 510(k) clearance for the S4 CERVICAL OCCIPITAL PLATE 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, Inc. (Center Valley, US). The FDA issued a Cleared decision on February 9, 2007 after a review of 207 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 Aesculap, Inc. devices

Submission Details

510(k) Number K062012 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 2006
Decision Date February 09, 2007
Days to Decision 207 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
85d slower than avg
Panel avg: 122d · This submission: 207d
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 Consultant

Aesculap AG
Kathy Racosky

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - NKB Thoracolumbosacral Pedicle Screw System

All 402
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K062012.
BEACON STABILIZATION SYSTEM
K073172 · Globus Medical, Inc. · Dec 2007
MODIFICATION TO:TSRH SPINAL SYSTEM
K072317 · Medtronic Sofamor Danek USA, Inc. · Sep 2007
MODIFICATION TO S4 SPINAL SYSTEM
K062327 · Aesculap, Inc. · Mar 2007
REVERE STABILIZATION SYSTEM
K061202 · Globus Medical, Inc. · Jul 2006
CD HORIZON SPINAL SYSTEM
K051674 · Medtronic Sofamor Danek USA, Inc. · Jul 2005
MODIFICATION TO PROTEX STABILIZATION SYSTEM
K042953 · Globus Medical, Inc. · Nov 2004