Cleared Traditional

K121569 - MATISSE ANTERIOR CERVICAL INTERBODY FUSION CAGE SYSTEM

K121569 is an FDA 510(k) clearance for MATISSE ANTERIOR CERVICAL INTERBODY FUS..., manufactured by Accel Spine. The device is a Class 2 Orthopedic device with product code ODP cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K121569 · Accel Spine · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2012
Decision
59d
Days
Class 2
Risk

K121569 is an FDA 510(k) clearance for the MATISSE ANTERIOR CERVICAL INTERBODY FUSION CAGE SYSTEM. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Accel Spine (Dallas, US). The FDA issued a Cleared decision on July 27, 2012 after a review of 59 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.

FDA 510(k) Submission Details - K121569

510(k) Number K121569 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 2012
Decision Date July 27, 2012
Days to Decision 59 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
63d faster than avg
Panel avg: 122d · This submission: 59d
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 352
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K121569.
CERVICAL CAGE
K122444 · Eisertech, LLC · Aug 2012
AVS AS PEEK SPACER
K120486 · Stryker Spine · Aug 2012
C7 ANTERIOR CERVICAL INTERVERTEBRAL FUSION CAGE
K121320 · Medyssey Co, Ltd. · Aug 2012
HONOUR SPACER SYSTEM
K120345 · Nexxt Spine, LLC · Jun 2012
SYNTHES ACIS/VERTEBRAL SPACER CR
K120275 · Synthes (Usa), LLC · May 2012
LEXUS CERVICAL INTERVERTEBRAL BODY FUSION CAGE SYSTEM
K120840 · L & K Biomed Co., Ltd. · May 2012