Cleared Traditional

K082774 - LANX CERVICAL INTERVERTEBRAL BODY FUSION DEVICE

K082774 is an FDA 510(k) clearance for LANX CERVICAL INTERVERTEBRAL BODY FUSIO..., manufactured by Lanx, LLC. The device is a Class 2 Orthopedic device with product code MAX cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K082774 · Lanx, LLC · Orthopedic device
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Oct 2008
Decision
29d
Days
Class 2
Risk

K082774 is an FDA 510(k) clearance for the LANX CERVICAL INTERVERTEBRAL BODY FUSION DEVICE. 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 Lanx, LLC (Broomfield, US). The FDA issued a Cleared decision on October 21, 2008 after a review of 29 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 Lanx, LLC devices

FDA 510(k) Submission Details - K082774

510(k) Number K082774 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2008
Decision Date October 21, 2008
Days to Decision 29 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
93d faster than avg
Panel avg: 122d · This submission: 29d
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 685
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K082774.
THEKEN SPINE VU EPOD AND VU LPOD SYSTEM
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CLYDESDALE SPINAL SYSTEM
K083026 · Medtronic Sofamor Danek · Dec 2008
HOLLYWOOD, PACIFICA, REDONDO, VENTURA
K082310 · Seaspine, Inc. · Nov 2008
SPINAL USA VBR SYSTEM
K081196 · Spinal USA · Oct 2008
MODIFICATION TO: CAPSTONE SPINAL SYSTEM
K082732 · Medtronic Sofamor Danek USA, Inc. · Oct 2008
MODIFICATION TO CAPSTONE SPINAL SYSTEM
K082342 · Medtronic Sofamor Danek · Sep 2008