Cleared Traditional

K181229 - TirboLOX-C Cervical IBFD

K181229 is the FDA 510(k) clearance for TirboLOX-C Cervical IBFD by Captiva Spine, Inc.. It is a Class 2 Orthopedic device (product code ODP) cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K181229 · Captiva Spine, Inc. · Orthopedic device
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Sep 2018
Decision
133d
Days
Class 2
Risk

K181229 is an FDA 510(k) clearance for the TirboLOX-C Cervical IBFD. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Captiva Spine, Inc. (Jupiter, US). The FDA issued a Cleared decision on September 19, 2018 after a review of 133 days - within the typical 510(k) review window.

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 Captiva Spine, Inc. devices

Submission Details

510(k) Number K181229 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 2018
Decision Date September 19, 2018
Days to Decision 133 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
11d slower than avg
Panel avg: 122d · This submission: 133d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 208
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K181229.
REVEL Spacers
K180909 · Globus Medical, Inc. · Dec 2018
Axis Chena Cervical PEEK Spacer System
K181140 · Axis Orthopaedics · Nov 2018
Neurostructures Cavetto® [MAX] Cervical Cage System
K181590 · Neurostructures, Inc. · Nov 2018
ACCUFUSE Cervical System
K181471 · Absolute Advantage Medical, LLC · Aug 2018
ATEC Cervical Spacer System
K181435 · Alphatec Spine, Inc. · Aug 2018
CxHA PEEK Cervical IBF System
K181115 · Innovasis, Inc. · Jul 2018