Cleared Traditional

K092017 - PIVOTEC LUMBAR INTERBODY FUSION DEVICE ...

K092017 is the FDA 510(k) clearance for PIVOTEC LUMBAR INTERBODY FUSION DEVICE ... by Captiva Spine, Inc.. It is a Class 2 Orthopedic device (product code MAX) cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K092017 · Captiva Spine, Inc. · Orthopedic device
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Dec 2009
Decision
148d
Days
Class 2
Risk

K092017 is an FDA 510(k) clearance for the PIVOTEC LUMBAR INTERBODY FUSION DEVICE (LIFD). Classified as Intervertebral Fusion Device With Bone Graft, Lumbar within the MAX classification (a category for intervertebral fusion devices and spinal implants), Class II - Special Controls.

Submitted by Captiva Spine, Inc. (Pleasant Grove, US). The FDA issued a Cleared decision on December 1, 2009 after a review of 148 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 K092017 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 2009
Decision Date December 01, 2009
Days to Decision 148 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d slower than avg
Panel avg: 122d · This submission: 148d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize 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 - MAX Intervertebral Fusion Device With Bone Graft, Lumbar

All 577
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K092017.
ESL SPINAL SYSTEM
K092574 · Ebi, L.P. · Feb 2010
PATRIOT TRANSCONTINENTAL LLIF SPACER
K093242 · Globus Medical, Inc. · Dec 2009
AVS PL PEEK SPACERS
K093704 · Stryker Corp. · Dec 2009
PERIMETER INTERBODY FUSION DEVICE
K090353 · Medtronic Sofamor Danek · Sep 2009
IBEX SPINAL SYSTEM
K091381 · Ebi, L.P. · Aug 2009
DEPUY SPINE BENGAL, CONCORDE, COUGAR, DEVEX AND LEOPARD SYSTEMS
K081917 · Depuy Spine, Inc. · May 2009