Cleared Traditional

K150619 - CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer System (FDA 510(k) Clearance)

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

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

Submission Details

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

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.

Device Classification

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.