Cleared Traditional

K150619 - CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer System

K150619 is an FDA 510(k) clearance for CONSTRUX Mini PEEK Spacer System, manufactured by Orthofix, Inc.. The device is a Class 2 Orthopedic device with product code ODP cleared through the Traditional 510(k) pathway after a 185-day FDA review.

K150619 · Orthofix, Inc. · Orthopedic device
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Sep 2015
Decision
185d
Days
Class 2
Risk

K150619 is an FDA 510(k) clearance for the CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer System. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Orthofix, Inc. (Lewisville, US). The FDA issued a Cleared decision on September 11, 2015 after a review of 185 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3080 - 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 Orthofix, Inc. devices

FDA 510(k) Submission Details - K150619

510(k) Number K150619 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 2015
Decision Date September 11, 2015
Days to Decision 185 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
63d slower than avg
Panel avg: 122d · This submission: 185d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ODP Device Classification - Class 2, Special Controls

Product Code ODP Intervertebral Fusion Device With Bone Graft, Cervical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize Cervical Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft.
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 - ODP Intervertebral Fusion Device With Bone Graft, Cervical

All 336
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K150619.
Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion Devices, Talos -C(HA) Cervical Intervertebral Body Fusion Devices
K150788 · Meditech Spine, LLC · Oct 2015
Hedgehog Cervical Interbody Fusion Device
K143685 · Vertera, Inc. · Sep 2015
Ackermann Intervertebral Body Fusion Device
K143450 · Ackermann Instrumente GmbH · Sep 2015
Xenco Medical Cervical Interbody System (Argus)
K152302 · Xenco Medical, LLC · Sep 2015
Genesys Spine Apache Cervical Interbody Fusion System
K150812 · Genesys Spine · Sep 2015
Foundation Interbody Devices
K150847 · Corelink, LLC · Aug 2015