Cleared Special

K103102 - LEUCADIA PEDICLE SCREW SYSTEM

K103102 is an FDA 510(k) clearance for LEUCADIA PEDICLE SCREW SYSTEM, manufactured by Phygen, LLC. The device is a Class 2 Orthopedic device with product code MNI cleared through the Special 510(k) pathway after a 111-day FDA review.

K103102 · Phygen, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2011
Decision
111d
Days
Class 2
Risk

K103102 is an FDA 510(k) clearance for the LEUCADIA PEDICLE SCREW SYSTEM. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by Phygen, LLC (Irvine, US). The FDA issued a Cleared decision on February 8, 2011 after a review of 111 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.

View all Phygen, LLC devices

FDA 510(k) Submission Details - K103102

510(k) Number K103102 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 2010
Decision Date February 08, 2011
Days to Decision 111 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
11d faster than avg
Panel avg: 122d · This submission: 111d
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 199
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K103102.
VENUS CERVICAL SPINAL FIXATION SYSTEM
K103414 · L & K Biomed Co., Ltd. · Jul 2011
EXACTECH GIBRALT SPINAL SYSTEM
K110197 · Exactech, Inc. · Jul 2011
EVEREST SPINAL SYSTEM
K103440 · K2m, Inc. · Mar 2011
MOUNTAINEER OCT SPINAL SYSTEM
K103100 · Depuy Spine, Inc. · Nov 2010
LIFE SPINE INTERSPINOUS FIXATION SYSTEM
K100407 · Life Spine · Nov 2010
LDR SPINE USA SPINETUNE TL SPINAL SYSTEM
K102331 · Ldr Spine USA · Oct 2010