Cleared Traditional

JAZZ PF (K191217) - FDA 510(k) Clearance

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

K191217 · Implanet, S.A. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Aug 2019
Decision
88d
Days
Class 2
Risk

K191217 is an FDA 510(k) clearance for the JAZZ PF. Classified as Bone Fixation Cerclage, Sublaminar (product code OWI), Class II - Special Controls.

Submitted by Implanet, S.A. (Martillac, FR). The FDA issued a Cleared decision on August 2, 2019 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3010 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Implanet, S.A. devices

Submission Details

510(k) Number K191217 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 2019
Decision Date August 02, 2019
Days to Decision 88 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
34d faster than avg
Panel avg: 122d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OWI Bone Fixation Cerclage, Sublaminar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3010
Definition Acts As A Bone Anchor For Temporary Stabilization, Or Used In Conjunction With Other Medical Implants Of Similar Metals When Wiring Is Needed, During Development Of A Spinal 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 M. 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 - OWI Bone Fixation Cerclage, Sublaminar

All 21
Devices cleared under the same product code (OWI) and FDA review panel - the closest regulatory comparables to K191217.
Mariner Cap System
K201240 · SeaSpine Orthopedics Corporation · Aug 2020
The Gecko Spinal System
K200281 · Ortho Development Corporation · Mar 2020
Response BandLoc Spinal Fixation
K200097 · OrthoPediatrics Corp. · Mar 2020
Karma® Fixation System
K190289 · Spinal Elements, Inc. · Apr 2019
NuVasive® VersaTie® System
K190418 · Nu Vasive, Incorporated · Mar 2019
Spinal Elements Cerclage System
K180728 · Spinal Elements, Inc. · Sep 2018