Cleared Traditional

K083425 - FUSION ADVANTAGE CERVICAL CAGE, FUSION ADVANTAGE LUMBAR CAGE

K083425 is an FDA 510(k) clearance for FUSION ADVANTAGE CERVICAL CAGE, manufactured by Adaptive Specialty, LLC. The device is a Class 2 Orthopedic device with product code ODP cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K083425 · Adaptive Specialty, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2009
Decision
121d
Days
Class 2
Risk

K083425 is an FDA 510(k) clearance for the FUSION ADVANTAGE CERVICAL CAGE, FUSION ADVANTAGE LUMBAR CAGE. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Adaptive Specialty, LLC (Round Rock, US). The FDA issued a Cleared decision on March 20, 2009 after a review of 121 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 Adaptive Specialty, LLC devices

FDA 510(k) Submission Details - K083425

510(k) Number K083425 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 2008
Decision Date March 20, 2009
Days to Decision 121 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
1d faster than avg
Panel avg: 122d · This submission: 121d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ODP Device Classification - Class 2, Special Controls

Product Code ODP Intervertebral Fusion Device With Bone Graft, Cervical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize Cervical 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 - ODP Intervertebral Fusion Device With Bone Graft, Cervical

All 263
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K083425.
SPINAL USA ANTERIOR CERVICAL INTERBODY FUSION DEVICE
K083118 · Spinal USA · May 2009
CALIX SPINAL IMPLANT SYSTEM
K083637 · X-Spine Systems, Inc. · Apr 2009
CAMBRIA
K082309 · Seaspine, Inc. · Apr 2009
AESCULAP CESPACE PEEK INTERVERTEBRAL BODY FUSION SYSTEM
K083311 · Aesculap Implant Systems, Inc. · Mar 2009
NUVASIVE COROENT SYSTEM
K081611 · Nuvasive, Inc. · Oct 2008
ATLAS SPINE SPACER
K081880 · Atlas Spine, Inc. · Oct 2008