Cleared Special

K122518 - SYNSTER (CERVICAL,ALIF, PLIF, PTLIF AND TLIF) CAGE HERA CERVICAL CAGE RHEA PLIF CAGE TALON TIFA CAGE (FDA 510(k) Clearance)

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K122518 · Bm Korea Co., Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2013
Decision
182d
Days
Class 2
Risk

K122518 is an FDA 510(k) clearance for the SYNSTER (CERVICAL,ALIF, PLIF, PTLIF AND TLIF) CAGE HERA CERVICAL CAGE RHEA PL.... Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Bm Korea Co., Ltd. (Fullerton, US). The FDA issued a Cleared decision on February 15, 2013 after a review of 182 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. 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Bm Korea Co., Ltd. devices

Submission Details

510(k) Number K122518 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 2012
Decision Date February 15, 2013
Days to Decision 182 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d slower than avg
Panel avg: 122d · This submission: 182d
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 345
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