Cleared Traditional

K132361 - EVEREST SPINAL SYSTEM

K132361 is the FDA 510(k) clearance for EVEREST SPINAL SYSTEM by K2m, Inc.. It is a Class 2 Orthopedic device (product code MNI) cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K132361 · K2m, Inc. · Orthopedic device
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Oct 2013
Decision
65d
Days
Class 2
Risk

K132361 is an FDA 510(k) clearance for the EVEREST SPINAL SYSTEM. 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 October 3, 2013 after a review of 65 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all K2m, Inc. devices

Submission Details

510(k) Number K132361 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 2013
Decision Date October 03, 2013
Days to Decision 65 days
Submission Type Traditional
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
57d faster than avg
Panel avg: 122d · This submission: 65d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K132361.
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM PREBENT CROSS-CONNECTORS
K141835 · Spineart · Sep 2014
MYSPINE PEDICLE SCREW PLACEMENT GUIDES
K132788 · Medacta International · May 2014
EVEREST SPINAL SYSTEM
K132757 · K2m, Inc. · Nov 2013
LOSPA IS PEDICLE SCREW (MONOAXIAL & POLYAXIAL), LOSPA IS ROD- STRAIGHT (STANDARD), LOSPA IS ROD- PRE BENT (STANDARD & BU
K132644 · Corentec Co., Ltd. · Sep 2013
CAPSURE PS SYSTEM
K132154 · Spine Wave, Inc. · Aug 2013
CERTEX SPINAL IMPLANT SYSTEM
K122163 · X-Spine Systems, Inc. · Oct 2012