Cleared Traditional

K120368 - CAPSTONE CONTROL SPINAL SYSTEM

K120368 is an FDA 510(k) clearance for CAPSTONE CONTROL SPINAL SYSTEM, manufactured by Medtronic Sofamor Danek USA, Inc.. The device is a Class 2 Orthopedic device with product code MAX cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K120368 · Medtronic Sofamor Danek USA, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2012
Decision
63d
Days
Class 2
Risk

K120368 is an FDA 510(k) clearance for the CAPSTONE CONTROL SPINAL SYSTEM. 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 Medtronic Sofamor Danek USA, Inc. (Memphis, US). The FDA issued a Cleared decision on April 9, 2012 after a review of 63 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 Medtronic Sofamor Danek USA, Inc. devices

FDA 510(k) Submission Details - K120368

510(k) Number K120368 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 2012
Decision Date April 09, 2012
Days to Decision 63 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 122d · This submission: 63d
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 849
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K120368.
LATERAL FUSION DEVICE
K112986 · Integra Spine (Integra Lifesciences) · May 2012
VENUS LUMBAR INTERVERTEBRAL BODY FUSION CAGE SYSTEM
K120063 · L & K Biomed Co., Ltd. · Apr 2012
TWIN PEAKS LUMBAR CAGE
K112696 · Qualgenix, LLC · Apr 2012
ZAVATION IBF SYSTEM
K120576 · Zavation, LLC · Mar 2012
ASFORA BULLET CAGE
K112648 · Medical Designs, LLC · Mar 2012
RELIANCE LUMBAR IBF SYSTEM
K113540 · Reliance Medical Systems, LLC · Mar 2012