Cleared Special

K122366 - TRYPTIK CC ANTERIOR INTERSOMATIC CERVIC...

K122366 is the FDA 510(k) clearance for TRYPTIK CC ANTERIOR INTERSOMATIC CERVIC... by Spineart. It is a Class 2 Orthopedic device (product code ODP) cleared through the Special 510(k) pathway after a 59-day FDA review.

K122366 · Spineart · Orthopedic device
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Oct 2012
Decision
59d
Days
Class 2
Risk

K122366 is an FDA 510(k) clearance for the TRYPTIK CC ANTERIOR INTERSOMATIC CERVICAL CAGE. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Spineart (Geneva, CH). The FDA issued a Cleared decision on October 4, 2012 after a review of 59 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3080 - 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.

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Submission Details

510(k) Number K122366 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2012
Decision Date October 04, 2012
Days to Decision 59 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
63d faster than avg
Panel avg: 122d · This submission: 59d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code ODP Intervertebral Fusion Device With Bone Graft, Cervical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize Cervical Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft.
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 - ODP Intervertebral Fusion Device With Bone Graft, Cervical

All 223
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K122366.
TYBER MEDICAL INTERBODY SYSTEM
K130573 · Tyber Medical, LLC · Sep 2013
ANATOMIC PEEK CERVICAL FUSION SYSTEM
K130177 · Medtronic Sofamor Danek USA, Inc. · Sep 2013
VUSION CS PLUS
K122588 · Ortho Development Corp. · Jun 2013
AVS AS PEEK SPACER
K120486 · Stryker Spine · Aug 2012
LEXUS CERVICAL INTERVERTEBRAL BODY FUSION CAGE SYSTEM
K120840 · L & K Biomed Co., Ltd. · May 2012
DEPUY PULSE CERVICAL CAGE SYSTEM
K120517 · Medos International SARL · Apr 2012