Cleared Abbreviated

K081673 - DYN-ALIF ANTEROLATERAL INTERVERTEBRAL BODY FUSION DEVICE

K081673 is an FDA 510(k) clearance for DYN-ALIF ANTEROLATERAL INTERVERTEBRAL B..., manufactured by Ionics Medical Corp.. The device is a Class 2 Orthopedic device with product code MAX cleared through the Abbreviated 510(k) pathway after a 154-day FDA review.

K081673 · Ionics Medical Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2008
Decision
154d
Days
Class 2
Risk

K081673 is an FDA 510(k) clearance for the DYN-ALIF ANTEROLATERAL 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 Ionics Medical Corp. (Ether, US). The FDA issued a Cleared decision on November 14, 2008 after a review of 154 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3080 - the FDA orthopedic device regulatory framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Ionics Medical Corp. devices

FDA 510(k) Submission Details - K081673

510(k) Number K081673 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 2008
Decision Date November 14, 2008
Days to Decision 154 days
Submission Type Abbreviated
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d slower than avg
Panel avg: 122d · This submission: 154d
Pathway characteristics
Standards-based clearance path.

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 687
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K081673.
EXPANDABLE PEEK-OPTIMA IMPLANT
K082406 · Ebi, L.P. · Jan 2009
THEKEN SPINE VU EPOD AND VU LPOD SYSTEM
K082712 · Theken Spine, LLC · Jan 2009
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