Cleared Traditional

K122163 - CERTEX SPINAL IMPLANT SYSTEM

K122163 is the FDA 510(k) clearance for CERTEX SPINAL IMPLANT SYSTEM by X-Spine Systems, Inc.. It is a Class 2 Orthopedic device (product code MNI) cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K122163 · X-Spine Systems, Inc. · Orthopedic device
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Oct 2012
Decision
103d
Days
Class 2
Risk

K122163 is an FDA 510(k) clearance for the CERTEX SPINAL IMPLANT SYSTEM. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by X-Spine Systems, Inc. (Miamisburg, US). The FDA issued a Cleared decision on October 31, 2012 after a review of 103 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all X-Spine Systems, Inc. devices

Submission Details

510(k) Number K122163 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 2012
Decision Date October 31, 2012
Days to Decision 103 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
19d faster than avg
Panel avg: 122d · This submission: 103d
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 K122163.
EVEREST SPINAL SYSTEM
K132361 · K2m, Inc. · Oct 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
CAPSURE(R) PS SYSTEM
K122233 · Spine Wave, Inc. · Oct 2012
CAPSURE(R) PS SYSTEM
K120646 · Spine Wave, Inc. · Jun 2012
RANGE SPINAL SYSTEM, UNIT ROD
K120899 · K2m, Inc. · May 2012