Cleared Traditional

K133192 - MECTALIF TIPEEK

K133192 is the FDA 510(k) clearance for MECTALIF TIPEEK by Medacta International. It is a Class 2 Orthopedic device (product code MAX) cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K133192 · Medacta International · Orthopedic device
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Jan 2014
Decision
105d
Days
Class 2
Risk

K133192 is an FDA 510(k) clearance for the MECTALIF TIPEEK. 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 Medacta International (Camarillo, US). The FDA issued a Cleared decision on January 30, 2014 after a review of 105 days - within the typical 510(k) review window.

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 Medacta International devices

Submission Details

510(k) Number K133192 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 2013
Decision Date January 30, 2014
Days to Decision 105 days
Submission Type Traditional
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
17d faster than avg
Panel avg: 122d · This submission: 105d
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 609
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K133192.
DEROYAL SPINE SPACER SYSTEM
K131292 · Deroyal Industries, Inc. · Feb 2014
JULIET LL LATERAL LUMBAR CAGE
K133557 · Spineart · Feb 2014
ARDIS INTERBODY SYSTEM
K133184 · Zimmer Spine, Inc. · Jan 2014
RAMPART-L
K133371 · Spineology, Inc. · Jan 2014
PERIMETER C SPINAL SYSTEM, CAPSTONE SPINAL SYSTEM, CAPSTONE L SPINAL SYSTEM, PERIMETER SPINAL SYSTEM
K133645 · Medtronic Sofamor Danek USA, Inc. · Jan 2014
COROENT STERILE IMPLANTS SYSTEM
K132601 · Nu Vasive, Incorporated · Dec 2013