Cleared Traditional

K153152 - Syzygy Stabilization System

K153152 is an FDA 510(k) clearance for Syzygy Stabilization System, manufactured by Amendia, Inc.. The device is a Class 2 Orthopedic device with product code NKB cleared through the Traditional 510(k) pathway after a 177-day FDA review.

K153152 · Amendia, Inc. · Orthopedic device
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Apr 2016
Decision
177d
Days
Class 2
Risk

K153152 is an FDA 510(k) clearance for the Syzygy Stabilization System. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Amendia, Inc. (Marietta, US). The FDA issued a Cleared decision on April 27, 2016 after a review of 177 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 Amendia, Inc. devices

FDA 510(k) Submission Details - K153152

510(k) Number K153152 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 2015
Decision Date April 27, 2016
Days to Decision 177 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
55d slower than avg
Panel avg: 122d · This submission: 177d
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 874
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K153152.
Threshold Pedicular Fixation System, Palisade Pedicular Fixation System
K160980 · Spineology, Inc. · May 2016
JAZZ CLAW System (hooks and rods) and JAZZ CLAW connector
K160226 · Implanet, S.A. · May 2016
Xenco Medical Pedicle Screw System
K160986 · Xenco Medical, LLC · May 2016
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