Cleared Traditional

K151704 - Diplomat® Spinal System

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

K151704 · Signus Medizintechnik GmbH · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K151704

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
Combination Product No
PCCP Authorized No
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.

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 Consultant

Empirical Testing Corp
Kenneth C Maxwell

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 873
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K151704.
Inertia Pedicle Screw and Deformity Correxxion System
K153453 · Nexxt Spine, LLC · Apr 2016
PASS LP Spinal System
K153413 · Medicrea International SA · Apr 2016
Revolution Spinal Fixation System
K160216 · Intelligent Implant Systems, LLC · Apr 2016
icotec Pedicle System
K151977 · Icotec AG · Apr 2016
Response 5.5 Spine System
K160466 · OrthoPediatrics Corp. · Mar 2016
Erisma-LP Spinal Fixation System
K153326 · Clariance, Sas · Mar 2016