Cleared Traditional

K120464 - INNESIS PEEK CAGE

K120464 is the FDA 510(k) clearance for INNESIS PEEK CAGE by Bk Meditech, Co., Ltd.. It is a Class 2 Orthopedic device (product code MAX) cleared through the Traditional 510(k) pathway after a 338-day FDA review.

K120464 · Bk Meditech, Co., Ltd. · Orthopedic device
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Jan 2013
Decision
338d
Days
Class 2
Risk

K120464 is an FDA 510(k) clearance for the INNESIS PEEK CAGE. Classified as Intervertebral Fusion Device With Bone Graft, Lumbar within the MAX classification (a category for intervertebral fusion devices and spinal implants), Class II - Special Controls.

Submitted by Bk Meditech, Co., Ltd. (Salt Lake City, US). The FDA issued a Cleared decision on January 18, 2013 after a review of 338 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Bk Meditech, Co., Ltd. devices

Submission Details

510(k) Number K120464 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 2012
Decision Date January 18, 2013
Days to Decision 338 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
216d slower than avg
Panel avg: 122d · This submission: 338d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize 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 - MAX Intervertebral Fusion Device With Bone Graft, Lumbar

All 577
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K120464.
ANATOMIC PEEK CERVICAL FUSION SYSTEM CORNERSTONE PSR CERVICAL FUSION SYSTEM PEEK PREVAIL CERVICAL INTERBODY DEVICE CAPST
K122037 · Medtronic Sofamor Danek, Inc. · Mar 2013
SPINEOLOGY PEEK LUMBAR INTERBODY FUSION DEVICE
K123652 · Spineology, Inc. · Mar 2013
LUCENT
K122967 · Spinal Elements, Inc. · Feb 2013
CALIBER SPACERS
K123231 · Globus Medical, Inc. · Jan 2013
FALCON SPACER
K123180 · Synthes USA Products, LLC · Jan 2013
PATRIOT SPACERS
K122097 · Globus Medical, Inc. · Dec 2012