Cleared Traditional

K162764 - JAZZ FRAME SYSTEM

K162764 is an FDA 510(k) clearance for JAZZ FRAME SYSTEM, manufactured by Implanet, S.A.. The device is a Class 2 Orthopedic device with product code NKB cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K162764 · Implanet, S.A. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2017
Decision
111d
Days
Class 2
Risk

K162764 is an FDA 510(k) clearance for the JAZZ FRAME SYSTEM. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Implanet, S.A. (Martillac, FR). The FDA issued a Cleared decision on January 19, 2017 after a review of 111 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 Implanet, S.A. devices

FDA 510(k) Submission Details - K162764

510(k) Number K162764 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2016
Decision Date January 19, 2017
Days to Decision 111 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
11d faster than avg
Panel avg: 122d · This submission: 111d
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 716
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K162764.
SeaSpine® Daytona® Small Stature Spinal System
K163604 · SeaSpine Orthopedics Corporation · Mar 2017
NuVasive® Reline® 4.5-5.0 System
K170126 · Nu Vasive, Incorporated · Mar 2017
PASS LP Spinal System
K162786 · Medicrea International SA · Jan 2017
CD HORIZON® Spinal System
K163301 · Medtronic Sofamor Danek USA, Inc. · Dec 2016
ENNOVATE Spinal System
K162134 · Aesculap Implant Systems, LLC · Dec 2016
VIPER PRIME™ additions to the VIPER® System
K162912 · Medos International SARL · Dec 2016