Cleared Special

K083865 - PILOT SPINAL SYSTEM

K083865 is the FDA 510(k) clearance for PILOT SPINAL SYSTEM by Life Spine. It is a Class 2 Orthopedic device (product code MNI) cleared through the Special 510(k) pathway after a 30-day FDA review.

K083865 · Life Spine · Orthopedic device
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Jan 2009
Decision
30d
Days
Class 2
Risk

K083865 is an FDA 510(k) clearance for the PILOT SPINAL SYSTEM. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by Life Spine (Hoffman Estates, US). The FDA issued a Cleared decision on January 28, 2009 after a review of 30 days - a notably fast clearance cycle.

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. 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 Life Spine devices

Submission Details

510(k) Number K083865 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 2008
Decision Date January 28, 2009
Days to Decision 30 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
92d faster than avg
Panel avg: 122d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 159
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K083865.
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM
K093170 · Spineart · Nov 2009
ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM
K091189 · Alphatec Spine, Inc. · Jul 2009
ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM
K090779 · Alphatec Spine, Inc. · Jul 2009
CAPSURE PS SYSTEM
K083743 · Spine Wave, Inc. · Jan 2009
CAPSURE(R) PS SYSTEM
K083353 · Spine Wave, Inc. · Dec 2008
ZODIC POLYAXIAL SPINAL FIXATION SYSTEM
K081158 · Alphatec Spine, Inc. · Jul 2008