Cleared Special

K120899 - RANGE SPINAL SYSTEM

K120899 is the FDA 510(k) clearance for RANGE SPINAL SYSTEM by K2m, Inc.. It is a Class 2 Orthopedic device (product code MNI) cleared through the Special 510(k) pathway after a 60-day FDA review.

K120899 · K2m, Inc. · Orthopedic device
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May 2012
Decision
60d
Days
Class 2
Risk

K120899 is an FDA 510(k) clearance for the RANGE SPINAL SYSTEM, UNIT ROD. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by K2m, Inc. (Leesburg, US). The FDA issued a Cleared decision on May 25, 2012 after a review of 60 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 K2m, Inc. devices

Submission Details

510(k) Number K120899 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 2012
Decision Date May 25, 2012
Days to Decision 60 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
62d faster than avg
Panel avg: 122d · This submission: 60d
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 K120899.
CERTEX SPINAL IMPLANT SYSTEM
K122163 · X-Spine Systems, Inc. · Oct 2012
CAPSURE(R) PS SYSTEM
K122233 · Spine Wave, Inc. · Oct 2012
CAPSURE(R) PS SYSTEM
K120646 · Spine Wave, Inc. · Jun 2012
LEXUS CERVICAL FIXATION SYSTEM
K120879 · L & K Biomed Co., Ltd. · May 2012
RANGE SPINAL SYSTEM (MESA AND DENALI)
K120099 · K2m, Inc. · May 2012
EVEREST SPINAL SYSTEM
K120656 · K2m, Inc. · Apr 2012