Cleared Special

K102995 - TALON SPINAL SYSTEM

K102995 is an FDA 510(k) clearance for TALON SPINAL SYSTEM, manufactured by Spine360. The device is a Class 2 Orthopedic device with product code MNI cleared through the Special 510(k) pathway after a 117-day FDA review.

K102995 · Spine360 · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2011
Decision
117d
Days
Class 2
Risk

K102995 is an FDA 510(k) clearance for the TALON SPINAL SYSTEM. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by Spine360 (Austin, US). The FDA issued a Cleared decision on February 2, 2011 after a review of 117 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - 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.

FDA 510(k) Submission Details - K102995

510(k) Number K102995 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 08, 2010
Decision Date February 02, 2011
Days to Decision 117 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
5d faster than avg
Panel avg: 122d · This submission: 117d
Pathway characteristics
Modification to existing cleared device.

MNI Device Classification - Class 2, Special Controls

Product Code MNI Orthosis, Spinal Pedicle Fixation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
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 - MNI Orthosis, Spinal Pedicle Fixation

All 302
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K102995.
ZENIUS SPINAL SYSTEM
K110283 · Medyssey Co, Ltd. · May 2011
EVEREST SPINAL SYSTEM
K103440 · K2m, Inc. · Mar 2011
LEUCADIA PEDICLE SCREW SYSTEM
K103102 · Phygen, LLC · Feb 2011
ZENIUS SPINAL SYSTEM
K103272 · Medyssey Co, Ltd. · Dec 2010
NOVEL III SPINAL FIXATION AND ADJUSTABLE BRIDGE SYSTEM
K103147 · Medyssey Co, Ltd. · Dec 2010
S 100 PEDICLE SCREW SYSTEM
K101682 · Renovis Surgical Technologies, LLC · Dec 2010
K102995 · TALON SPINAL SYSTEM
Download PDF FDA Summary Spine360