Cleared Traditional

K151704 - Diplomat Spinal System

K151704 is the FDA 510(k) clearance for Diplomat Spinal System by Signus Medizintechnik GmbH. It is a Class 2 Orthopedic device (product code NKB) cleared through the Traditional 510(k) pathway after a 294-day FDA review.

K151704 · Signus Medizintechnik GmbH · Orthopedic device
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Apr 2016
Decision
294d
Days
Class 2
Risk

K151704 is an FDA 510(k) clearance for the Diplomat® 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 Signus Medizintechnik GmbH (Alzenau, DE). The FDA issued a Cleared decision on April 13, 2016 after a review of 294 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 Signus Medizintechnik GmbH devices

Submission Details

510(k) Number K151704 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 2015
Decision Date April 13, 2016
Days to Decision 294 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
172d slower than avg
Panel avg: 122d · This submission: 294d
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 650
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K151704.
NuVasive® Reline® System
K160989 · Nu Vasive, Incorporated · Jun 2016
Mariner Pedicle Screw System
K160902 · SeaSpine Orthopedics Corporation · May 2016
Threshold Pedicular Fixation System, Palisade Pedicular Fixation System
K160980 · Spineology, Inc. · May 2016
Response 5.5 Spine System
K160466 · OrthoPediatrics Corp. · Mar 2016
Palisade Pedicular Fixation System
K153323 · Spineology, Inc. · Feb 2016
CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with the STEALTHSTATION System, Medtronic Reusable Instruments for Use with the IPC POWEREASE System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION and IPC POWEREASE Systems
K153442 · Medtronic Sofamor Danek USA, Inc. · Feb 2016