Cleared Traditional

K080058 - TURBO PRIME IBD SYSTEM

K080058 is an FDA 510(k) clearance for TURBO PRIME IBD SYSTEM, manufactured by Spineselect, LLC. The device is a Class 2 Orthopedic device with product code MAX cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K080058 · Spineselect, LLC · Orthopedic device
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Apr 2008
Decision
98d
Days
Class 2
Risk

K080058 is an FDA 510(k) clearance for the TURBO PRIME IBD SYSTEM. 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 Spineselect, LLC (Apple Valley, US). The FDA issued a Cleared decision on April 16, 2008 after a review of 98 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 Spineselect, LLC devices

FDA 510(k) Submission Details - K080058

510(k) Number K080058 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 2008
Decision Date April 16, 2008
Days to Decision 98 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
24d faster than avg
Panel avg: 122d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MAX Device Classification - Class 2, Special Controls

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 661
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K080058.
AESCULAP PEEK INTERVERTEBRAL BODY FUSION SYSTEM: A SPACE, CESPACE, PROSPACE, T-SPACE
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K073291 · Medtronic Sofamor Danek USA, Inc. · Apr 2008
FOUNDATION CAGE
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INTREPID SPINAL SYSTEM
K080083 · Medtronic Sofamor Danek · Apr 2008
AVS PL PEEK SPACERS, MODELS 48351 AND 48353
K080758 · Stryker Corp. · Mar 2008
AVS PL PEEK SPACERS, MODELS 48351XXX AND 48353XXX
K073470 · Stryker Spine · Mar 2008