Cleared Traditional

K121288 - FUSE CAGE

K121288 is an FDA 510(k) clearance for FUSE CAGE, manufactured by Advanced Medical Technologies AG. The device is a Class 2 Orthopedic device with product code MAX cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K121288 · Advanced Medical Technologies AG · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2012
Decision
60d
Days
Class 2
Risk

K121288 is an FDA 510(k) clearance for the FUSE CAGE. 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 Advanced Medical Technologies AG (Nonnweiler-Braunshausen, DE). The FDA issued a Cleared decision on June 29, 2012 after a review of 60 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 - K121288

510(k) Number K121288 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2012
Decision Date June 29, 2012
Days to Decision 60 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
62d faster than avg
Panel avg: 122d · This submission: 60d
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 896
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K121288.
VENUS LUMBAR INTERVERTEBRAL BODY FUSION CAGE SYSTEM
K121096 · L & K Biomed Co., Ltd. · Jul 2012
ACCULIF TL CAGE
K121683 · Coalign Innovations, Inc. · Jul 2012
DEPUY PULSE LUMBAR CAGE SYSTEM
K120966 · Medos International SARL · Jul 2012
WAVE O CAGE
K121330 · Advanced Medical Technologies AG · Jun 2012
LOOP CAGE
K121332 · Advanced Medical Technologies AG · Jun 2012
WAVE D CAGE
K121333 · Advanced Medical Technologies AG · Jun 2012
K121288 · FUSE CAGE
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