Cleared Traditional

K081917 - DEPUY SPINE BENGAL

K081917 is the FDA 510(k) clearance for DEPUY SPINE BENGAL by Depuy Spine, Inc.. It is a Class 2 Orthopedic device (product code MAX) cleared through the Traditional 510(k) pathway after a 323-day FDA review.

K081917 · Depuy Spine, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
May 2009
Decision
323d
Days
Class 2
Risk

K081917 is an FDA 510(k) clearance for the DEPUY SPINE BENGAL, CONCORDE, COUGAR, DEVEX AND LEOPARD SYSTEMS. 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 22, 2009 after a review of 323 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Depuy Spine, Inc. devices

Submission Details

510(k) Number K081917 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 2008
Decision Date May 22, 2009
Days to Decision 323 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
201d slower than avg
Panel avg: 122d · This submission: 323d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Orthopedic devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT00215293 Completed Interventional Industry-sponsored

Cervical I/F Cage for Anterior Cervical Fusion

A Randomized Multi-Center Study to Evaluate the Safety and Efficacy of the Cervical I/F Cage for Anterior Cervical Fusion

240
Patients (actual)
Treatment
Purpose
Open label
Masking
Condition studied Cervical Intervertebral Disc Degeneration
Study design Parallel
Eligibility All sexes · 18 Years+
Sponsor DePuy Spine (industry)
Started 2000-08-01 → Primary completion 2007-10-01
Primary outcome
Fusion Status
Secondary outcome
Adverse Events
Study completed - no results published. This trial concluded in 2007 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov

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 K081917.
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
GUIDED LATERAL INTERBODY FUSION (GLIF) SYSTEM
K090425 · Alphatec Spine, Inc. · May 2009
DEPUY SPINE LATERAL SYSTEM
K090899 · Depuy Spine, Inc. · May 2009
STRYKER SPINE AVS PL PEEK SPACERS
K090816 · Stryker Corp. · Apr 2009