Cleared Special

K172437 - CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR® SA PTC Spacer System

K172437 is an FDA 510(k) clearance for CONSTRUX Mini PTC Spacer System, manufactured by Orthofix, Inc.. The device is a Class 2 Orthopedic device with product code ODP cleared through the Special 510(k) pathway after a 83-day FDA review.

K172437 · Orthofix, Inc. · Orthopedic device
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Nov 2017
Decision
83d
Days
Class 2
Risk

K172437 is an FDA 510(k) clearance for the CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR® SA PTC Sp.... 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 November 2, 2017 after a review of 83 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

FDA 510(k) Submission Details - K172437

510(k) Number K172437 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 2017
Decision Date November 02, 2017
Days to Decision 83 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
39d faster than avg
Panel avg: 122d · This submission: 83d
Pathway characteristics
Modification to existing cleared device.

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 K172437.
Altus Spine Cervical Interbody Fusion System
K172253 · Altus Partners, LLC · Nov 2017
Vertera Spine Cohere Cervical Interbody Fusion Device
K173030 · Nu Vasive, Incorporated · Nov 2017
SPIRA-C Open Matrix Cervical Interbody
K172446 · Camber Spine Technologies · Nov 2017
Sapphire Cervical Implant System
K172674 · Sapphire Medical Group · Nov 2017
SCARLET AC-T
K172065 · Spineart · Sep 2017
Shanghai Sanyou PEEK Cage System
K163422 · Shanghai Sanyou Medical Co, Ltd. · Sep 2017