Cleared Traditional

K092193 - SPINAL USA INTERBODY CAGES

K092193 is an FDA 510(k) clearance for SPINAL USA INTERBODY CAGES, manufactured by Spinal USA. The device is a Class 2 Orthopedic device with product code MAX cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K092193 · Spinal USA · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2009
Decision
66d
Days
Class 2
Risk

K092193 is an FDA 510(k) clearance for the SPINAL USA INTERBODY CAGES. 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 Spinal USA (Pear, US). The FDA issued a Cleared decision on September 25, 2009 after a review of 66 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Spinal USA devices

FDA 510(k) Submission Details - K092193

510(k) Number K092193 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 2009
Decision Date September 25, 2009
Days to Decision 66 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
56d faster than avg
Panel avg: 122d · This submission: 66d
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 643
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K092193.
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
DORADO WIDE INTERVERTEBRAL BODY CAGE, MODELS: IM2010-IM2031
K091638 · Spinefrontier, Inc. · Sep 2009
IBEX SPINAL SYSTEM
K091381 · Ebi, L.P. · Aug 2009
MODIFICATION TO LDR SPINE ROI INTERBODY FUSION SYSTEM
K090507 · Ldr Spine USA · Jun 2009