Cleared Special

K133216 - CRESCENT SPINAL SYSTEM

K133216 is an FDA 510(k) clearance for CRESCENT SPINAL SYSTEM, manufactured by Medtronic Sofamor Danek, Inc.. The device is a Class 2 Orthopedic device with product code MAX cleared through the Special 510(k) pathway after a 35-day FDA review.

K133216 · Medtronic Sofamor Danek, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2013
Decision
35d
Days
Class 2
Risk

K133216 is an FDA 510(k) clearance for the CRESCENT 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, Inc. (Memphis, US). The FDA issued a Cleared decision on November 22, 2013 after a review of 35 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Medtronic Sofamor Danek, Inc. devices

FDA 510(k) Submission Details - K133216

510(k) Number K133216 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 2013
Decision Date November 22, 2013
Days to Decision 35 days
Submission Type Special
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
87d faster than avg
Panel avg: 122d · This submission: 35d
Pathway characteristics
Modification to existing cleared device.

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 K133216.
GENESYS SPINE APACHE LATERAL LUMBAR INTERBODY FUSION SYSTEM
K130913 · Genesys Spine · Dec 2013
CLYDESDALE SPINAL SYSTEM
K132897 · Medtronic Sofamor Danek, Inc. · Dec 2013
K7 LUMBAR SPACERS
K133126 · K7, LLC · Dec 2013
PERIMETER INTERBODY FUSION DEVICE
K131669 · Medtronic Sofamor Danek USA, Inc. · Nov 2013
BIOLIGN ACIF SYSTEMS, BIOLIGN STACC ACIF SYSTEM, BIOLIGN TLIF SYSTEM
K130274 · Elite Surgical Supplies (Pty), Ltd. · Oct 2013
CALIX LUMBAR SPINAL IMPLANT SYSTEM
K131350 · X-Spine Systems, Inc. · Oct 2013