Cleared Traditional

K130853 - IDYS(TM) C

K130853 is an FDA 510(k) clearance for IDYS(TM) C, manufactured by Clariance. The device is a Class 2 Orthopedic device with product code ODP cleared through the Traditional 510(k) pathway after a 230-day FDA review.

K130853 · Clariance · Orthopedic device
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Nov 2013
Decision
230d
Days
Class 2
Risk

K130853 is an FDA 510(k) clearance for the IDYS(TM) C. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Clariance (Philedelphia, US). The FDA issued a Cleared decision on November 13, 2013 after a review of 230 days - an extended review cycle.

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

FDA 510(k) Submission Details - K130853

510(k) Number K130853 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 2013
Decision Date November 13, 2013
Days to Decision 230 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
108d slower than avg
Panel avg: 122d · This submission: 230d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ODP Device Classification - Class 2, Special Controls

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 243
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K130853.
C-PLUS
K133623 · Pioneer Surgical Technology, Inc. · Feb 2014
GENESYS SPINE APACHE IBFD STAR CERVICAL SYSTEM
K130317 · Genesys Spine · Dec 2013
PERIMETER C SPINAL SYSTEM
K132584 · Medtronic Sofamor Danek USA, Inc. · Dec 2013
TYBER MEDICAL INTERBODY SYSTEM
K130573 · Tyber Medical, LLC · Sep 2013
ANATOMIC PEEK CERVICAL FUSION SYSTEM
K130177 · Medtronic Sofamor Danek USA, Inc. · Sep 2013
RELIANCE CERVICAL IBF SYSTEM
K131429 · Reliance Medical Systems, LLC · Sep 2013