Cleared Abbreviated

K150455 - RT2 Trabeculite Titanium Cervical Cage ...

K150455 is an FDA 510(k) clearance for RT2 Trabeculite Titanium Cervical Cage ..., manufactured by Rhausler, Inc.. The device is a Class 2 Orthopedic device with product code ODP cleared through the Abbreviated 510(k) pathway after a 272-day FDA review.

K150455 · Rhausler, Inc. · Orthopedic device
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Nov 2015
Decision
272d
Days
Class 2
Risk

K150455 is an FDA 510(k) clearance for the RT2 Trabeculite Titanium Cervical Cage System. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Rhausler, Inc. (San Carlos, US). The FDA issued a Cleared decision on November 19, 2015 after a review of 272 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Rhausler, Inc. devices

FDA 510(k) Submission Details - K150455

510(k) Number K150455 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 2015
Decision Date November 19, 2015
Days to Decision 272 days
Submission Type Abbreviated
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
150d slower than avg
Panel avg: 122d · This submission: 272d
Pathway characteristics
Standards-based clearance path.

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 252
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K150455.
PERIMETER C (Titanium) Spinal System
K153438 · Medtronic Sofamor Danek USA, Inc. · Mar 2016
CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical Interbody Device
K153373 · Medtronic Sofamor Danek · Jan 2016
AERO -C Cervical Cage System
K152532 · Stryker Spine · Dec 2015
CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer System
K150619 · Orthofix, Inc. · Sep 2015
Genesys Spine Apache Cervical Interbody Fusion System
K150812 · Genesys Spine · Sep 2015
Foundation Interbody Devices
K150847 · Corelink, LLC · Aug 2015