Cleared Traditional

K141333 - ARENA-C TIFUSE CERVICAL INTERVERTEBRAL BODY FUSION DEVICE

K141333 is an FDA 510(k) clearance for ARENA-C TIFUSE CERVICAL INTERVERTEBRAL ..., manufactured by Spinefrontier, Inc.. The device is a Class 2 Orthopedic device with product code ODP cleared through the Traditional 510(k) pathway after a 188-day FDA review.

K141333 · Spinefrontier, Inc. · Orthopedic device
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Nov 2014
Decision
188d
Days
Class 2
Risk

K141333 is an FDA 510(k) clearance for the ARENA-C TIFUSE CERVICAL INTERVERTEBRAL BODY FUSION DEVICE. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Spinefrontier, Inc. (Colorado Springs, US). The FDA issued a Cleared decision on November 25, 2014 after a review of 188 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 Spinefrontier, Inc. devices

FDA 510(k) Submission Details - K141333

510(k) Number K141333 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 2014
Decision Date November 25, 2014
Days to Decision 188 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
66d slower than avg
Panel avg: 122d · This submission: 188d
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 312
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K141333.
Coalition AGX Plate and Coalition AGX Spacer
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Valeo C Spacer System, Valeo II C IBF Device
K142264 · Amedica Corp. · Dec 2014
AVS AS PEEK Spacer
K142251 · Stryker Corporation · Nov 2014
NUVASIVE COROENT SMALL CONTOURED INTERBODY SYSTEM
K142050 · Nu Vasive, Incorporated · Oct 2014
SPINEFRONTIER ARENA-C HA PEEK CERVICAL INTERVERTEBRAL BODY FUSION DEVICE
K142026 · Spinefrontier, Inc. · Oct 2014