Cleared Special

K202949 - CONSTRUX Mini PEEK Spacer System

K202949 is the FDA 510(k) clearance for CONSTRUX Mini PEEK Spacer System by Orthofix, Inc.. It is a Class 2 Orthopedic device (product code ODP) cleared through the Special 510(k) pathway after a 29-day FDA review.

K202949 · Orthofix, Inc. · Orthopedic device
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Oct 2020
Decision
29d
Days
Class 2
Risk

K202949 is an FDA 510(k) clearance for the CONSTRUX Mini PEEK 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 October 29, 2020 after a review of 29 days - a notably fast clearance cycle.

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

Submission Details

510(k) Number K202949 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2020
Decision Date October 29, 2020
Days to Decision 29 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
93d faster than avg
Panel avg: 122d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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 219
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K202949.
ChoiceSpine Tiger Shark Cervical Spacer System
K201643 · Choice Spine, LLC · Dec 2020
Lucero Medical Cervical Cage System
K200549 · Lucero Medical, LLC · Dec 2020
Atlas Spine Rebar (Ti) Spacer System
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CONSTRUX Mini PTC Spacer System
K202666 · Orthofix, Inc. · Oct 2020
Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical Intervertebral Body Fusion System
K201506 · Meditech Spine, LLC · Sep 2020
Cavetto [MAX] Cervical Cage System
K201769 · Neurostructures, Inc. · Sep 2020