Cleared Traditional

K122872 - INTERVERTEBRAL BODY FUSION DEVICE

K122872 is an FDA 510(k) clearance for INTERVERTEBRAL BODY FUSION DEVICE, manufactured by Dio Medical Co., Ltd.. The device is a Class 2 Orthopedic device with product code ODP cleared through the Traditional 510(k) pathway after a 162-day FDA review.

K122872 · Dio Medical Co., Ltd. · Orthopedic device
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Feb 2013
Decision
162d
Days
Class 2
Risk

K122872 is an FDA 510(k) clearance for the INTERVERTEBRAL BODY FUSION DEVICE. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Dio Medical Co., Ltd. (Brea, US). The FDA issued a Cleared decision on February 28, 2013 after a review of 162 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 Dio Medical Co., Ltd. devices

FDA 510(k) Submission Details - K122872

510(k) Number K122872 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 2012
Decision Date February 28, 2013
Days to Decision 162 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
40d slower than avg
Panel avg: 122d · This submission: 162d
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 252
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K122872.
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AVS AS PEEK SPACER
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K120345 · Nexxt Spine, LLC · Jun 2012