Cleared Special

STALIF MIDLINE (K101301) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K101301 · Centinel Spine · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2010
Decision
137d
Days
Class 2
Risk

K101301 is an FDA 510(k) clearance for the STALIF MIDLINE. 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 Centinel Spine (Washington, US). The FDA issued a Cleared decision on September 24, 2010 after a review of 137 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. 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Centinel Spine devices

Submission Details

510(k) Number K101301 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 2010
Decision Date September 24, 2010
Days to Decision 137 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d slower than avg
Panel avg: 122d · This submission: 137d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 436
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K101301.
CRESCENT (R) SPINAL SYSTEM TITANIUM
K110543 · Medtronic Sofamor Danek USA, Inc. · Aug 2011
CALIBER SPACER
K102293 · Globus Medical, Inc. · Jan 2011
PATRIOT TRANSCONTINENTAL M SPACERS
K102313 · Globus Medical, Inc. · Dec 2010
PATRIOT TRANSCONTINENTAL LLIF SPACER
K093242 · Globus Medical, Inc. · Dec 2009
MODIFICATION TO: CAPSTONE SPINAL SYSTEM
K082732 · Medtronic Sofamor Danek USA, Inc. · Oct 2008
CAPSTONE SPINAL SYSTEM
K073291 · Medtronic Sofamor Danek USA, Inc. · Apr 2008