Cleared Traditional

ISS-JAZZ Screw System and JAZZ CAP SP (K182771) - FDA 510(k) Clearance

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

K182771 · Implanet, S.A. · Orthopedic device
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Mar 2019
Decision
165d
Days
Class 2
Risk

K182771 is an FDA 510(k) clearance for the ISS-JAZZ Screw System and JAZZ CAP SP. 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. (Allée François Magendie, FR). The FDA issued a Cleared decision on March 12, 2019 after a review of 165 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 Implanet, S.A. devices

Submission Details

510(k) Number K182771 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2018
Decision Date March 12, 2019
Days to Decision 165 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
43d slower than avg
Panel avg: 122d · This submission: 165d
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

Hogan Lovells US LLP
Janice Hogan

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 447
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K182771.
Zavation Spinal System
K190361 · Zavation Medical Products, LLC · Mar 2019
EUROPA Pedicle Screw System
K180337 · MiRus, LLC · Mar 2019
Modular Spinal Fixation System
K183430 · Life Spine, Inc. · Mar 2019
NuVasive Reline System
K182974 · Nu Vasive, Incorporated · Feb 2019
Pedimax II - Pedicular Screw Spinal System
K180626 · Gm Dos Reis Industria E Comerico Ltda. · Feb 2019
EUROPA™ Pedicle Screw System
K182970 · MiRus, LLC · Jan 2019