Cleared Traditional

K142152 - CONSTRUX MINI PEEK

Also marketed or referenced as:
SPACER SYSTEM, TI SPACER SYSTEM, CERVICAL STAND ALONE SYSTEM

K142152 is an FDA 510(k) clearance for CONSTRUX MINI PEEK, 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 155-day FDA review.

K142152 · Orthofix, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2015
Decision
155d
Days
Class 2
Risk

K142152 is an FDA 510(k) clearance for the CONSTRUX MINI PEEK. 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 January 8, 2015 after a review of 155 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 - K142152

510(k) Number K142152 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2014
Decision Date January 08, 2015
Days to Decision 155 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
33d slower than avg
Panel avg: 122d · This submission: 155d
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 K142152.
LnK Cervical Interbody Fusion Cage System
K143360 · L & K Biomed Co., Ltd. · Apr 2015
Coalition AGX Plate and Coalition AGX Spacer
K142218 · Globus Medical, Inc. · Mar 2015
Talos-C(HA) Cervical Intervertebral Body Fusion Devices
K142345 · Meditech Spine, LLC · Feb 2015
nvc
K142328 · Nvision Biomedical Technologies, LLC · Dec 2014
POROSTEON PHUSION METAL CERVICAL CAGE
K142041 · Porosteon, Inc. · Dec 2014
Valeo C Spacer System, Valeo II C IBF Device
K142264 · Amedica Corp. · Dec 2014