Cleared Special

Erisma® Deformity Spinal System (K240872) - FDA 510(k) Clearance

Also marketed or referenced as:
Erisma® Lp Spinal Fixation System

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K240872 · Clariance · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2024
Decision
28d
Days
Class 2
Risk

K240872 is an FDA 510(k) clearance for the Erisma® Deformity Spinal System. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Clariance (Beaurains, FR). The FDA issued a Cleared decision on April 26, 2024 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Clariance devices

Submission Details

510(k) Number K240872 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 2024
Decision Date April 26, 2024
Days to Decision 28 days
Submission Type Special
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
94d faster than avg
Panel avg: 122d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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

Clariance, Inc.
Magalie Hennequin

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 K240872.
JAZZ Spinal System
K240392 · Implanet · May 2024
Salvo® Spine System
K240685 · Spine Wave, Inc. · May 2024
POWEReam Xia/Serrato
K240526 · Stryker Instruments · Apr 2024
CarboClear® Hybrid Pedicle Screw System
K240846 · CarboFix Orthopedics , Ltd. · Apr 2024
NewPort Spinal System
K232566 · SeaSpine Orthopedics Corporation · Apr 2024
G Surgical Marksman MIS System
K240737 · G Surgical, LLC · Apr 2024