Cleared Traditional

K143731 - IMPLANET Spine System (ISS)

K143731 is an FDA 510(k) clearance for IMPLANET Spine System (ISS), 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 106-day FDA review.

K143731 · Implanet, S.A. · Orthopedic device
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Apr 2015
Decision
106d
Days
Class 2
Risk

K143731 is an FDA 510(k) clearance for the IMPLANET Spine System (ISS). 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 April 14, 2015 after a review of 106 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 - K143731

510(k) Number K143731 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 2014
Decision Date April 14, 2015
Days to Decision 106 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
16d faster than avg
Panel avg: 122d · This submission: 106d
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

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 - NKB Thoracolumbosacral Pedicle Screw System

All 913
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K143731.
Mont Blanc Spinal System
K150185 · Spineway · May 2015
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VENUS Spinal Fixation System
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CD HORIZON Spinal System, IPC POWEREASE System
K143019 · Medtronic Sofamor Danek USA, Inc. · Apr 2015
Santis Pedicle Screw System
K150507 · Lanterna Medical Technologies · Apr 2015
Range/Denali/Mesa Spinal System
K150325 · K2m, Inc. · Mar 2015