Cleared Traditional

K090899 - DEPUY SPINE LATERAL SYSTEM

K090899 is the FDA 510(k) clearance for DEPUY SPINE LATERAL SYSTEM by Depuy Spine, Inc.. It is a Class 2 Orthopedic device (product code MAX) cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K090899 · Depuy Spine, Inc. · Orthopedic device
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May 2009
Decision
48d
Days
Class 2
Risk

K090899 is an FDA 510(k) clearance for the DEPUY SPINE LATERAL 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 Depuy Spine, Inc. (Raynham, US). The FDA issued a Cleared decision on May 19, 2009 after a review of 48 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 Depuy Spine, Inc. devices

Submission Details

510(k) Number K090899 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2009
Decision Date May 19, 2009
Days to Decision 48 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
74d faster than avg
Panel avg: 122d · This submission: 48d
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 576
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K090899.
IBEX SPINAL SYSTEM
K091381 · Ebi, L.P. · Aug 2009
DEPUY SPINE BENGAL, CONCORDE, COUGAR, DEVEX AND LEOPARD SYSTEMS
K081917 · Depuy Spine, Inc. · May 2009
GUIDED LATERAL INTERBODY FUSION (GLIF) SYSTEM
K090425 · Alphatec Spine, Inc. · May 2009
STRYKER SPINE AVS PL PEEK SPACERS
K090816 · Stryker Corp. · Apr 2009
AVS ANTERIOR LARGE PEEK SPACERS
K090166 · Stryker Corp. · Apr 2009
NOVEL ALIF SPINAL SPACER SYSTEM
K090782 · Alphatec Spine, Inc. · Apr 2009