Cleared Traditional

K133094 - CERTEX OCT SPINAL IMPLANT SYSTEM

K133094 is the FDA 510(k) clearance for CERTEX OCT SPINAL IMPLANT SYSTEM by X-Spine Systems, Inc.. It is a Class 2 Orthopedic device (product code KWP) cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K133094 · X-Spine Systems, Inc. · Orthopedic device
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Dec 2013
Decision
72d
Days
Class 2
Risk

K133094 is an FDA 510(k) clearance for the CERTEX OCT SPINAL IMPLANT SYSTEM. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by X-Spine Systems, Inc. (Miamisburg, US). The FDA issued a Cleared decision on December 11, 2013 after a review of 72 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3050 - 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 X-Spine Systems, Inc. devices

Submission Details

510(k) Number K133094 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2013
Decision Date December 11, 2013
Days to Decision 72 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
50d faster than avg
Panel avg: 122d · This submission: 72d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KWP Appliance, Fixation, Spinal Interlaminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3050
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 - KWP Appliance, Fixation, Spinal Interlaminal

All 271
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K133094.
VIRAGE OCT SPINAL FIXATION SYSTEM
K133556 · Zimmer Spine, Inc. · Jun 2014
CENTURION POCT SYSTEM
K131833 · Orthofix, Inc. · Jan 2014
SYNAPSE SYSTEM
K133698 · Synthes USA Products, LLC · Jan 2014
TIGER OCCIPITAL-CERVICAL-THORACIC SPINAL FIXATION SYSTEM
K132504 · Corelink, LLC · Nov 2013
LOTUS
K131427 · Spinal Elements, Inc. · Oct 2013
MOUNTAINEER OCT SPINAL SYSTEM
K132332 · Medos International SARL · Aug 2013