Cleared Traditional

K203342 - CONSTRUX Mini Ti Spacer System

K203342 is the FDA 510(k) clearance for CONSTRUX Mini Ti Spacer System by Orthofix, Inc.. It is a Class 2 Orthopedic device (product code ODP) cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K203342 · Orthofix, Inc. · Orthopedic device
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Mar 2021
Decision
125d
Days
Class 2
Risk

K203342 is an FDA 510(k) clearance for the CONSTRUX Mini 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 March 18, 2021 after a review of 125 days - within the typical 510(k) review window.

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 K203342 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2020
Decision Date March 18, 2021
Days to Decision 125 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
3d slower than avg
Panel avg: 122d · This submission: 125d
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.

Regulatory Peers - ODP Intervertebral Fusion Device With Bone Graft, Cervical

All 215
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K203342.
DEXA-C Cervical Interbody System
K210521 · Aurora Spine, Inc. · Aug 2021
GPS Cervical Spacers
K210890 · G Surgical, LLC · Apr 2021
Blustone Synergy Interbody Fusion System
K203520 · Blustone Synergy, LLC · Apr 2021
BEE HA Cage
K203444 · NGMedical GmbH · Mar 2021
Prase PEEK Anterior Cervical Interbody Spacer
K202872 · Gbs Commonwealth Co., Ltd. · Feb 2021
BEE Cages
K200429 · NGMedical GmbH · Jan 2021