Cleared Special

Curiteva Porous PEEK Laminoplasty System (K243137) - FDA 510(k) Clearance

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

K243137 · Curiteva, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2024
Decision
28d
Days
Class 2
Risk

K243137 is an FDA 510(k) clearance for the Curiteva Porous PEEK Laminoplasty System. Classified as Orthosis, Spine, Plate, Laminoplasty, Metal (product code NQW), Class II - Special Controls.

Submitted by Curiteva, Inc. (Tanner, US). The FDA issued a Cleared decision on October 28, 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 888.3050 - 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 Curiteva, Inc. devices

Submission Details

510(k) Number K243137 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2024
Decision Date October 28, 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 NQW Orthosis, Spine, Plate, Laminoplasty, Metal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3050
Definition This Device Is A Plate That Is Attached To The Lamina After A Laminoplasty Or Laminectomy Procedure.
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 - NQW Orthosis, Spine, Plate, Laminoplasty, Metal

All 12
Devices cleared under the same product code (NQW) and FDA review panel - the closest regulatory comparables to K243137.
AQUA Laminoplasty Systems
K252930 · ZheJiang Decans Medical Devices Co., Ltd. · May 2026
Vy Spine™ VyLam™ Laminoplasty System
K242784 · Vy Spine, LLC · Oct 2024
Vy Spine™ VyLam™ Laminoplasty System
K232471 · Vy Spine, LLC · Oct 2023
Curiteva Laminoplasty System
K231232 · Curiteva, Inc. · Jun 2023
Centerpiece Plate Fixation System
K212428 · Medtronic Sofamor Danek · Dec 2021
Hinged Laminoplasty System
K191927 · Life Spine, Inc. · Sep 2019