Cleared Traditional

K110927 - MECTALIF

K110927 is the FDA 510(k) clearance for MECTALIF by Medacta International. It is a Class 2 Orthopedic device (product code MAX) cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K110927 · Medacta International · Orthopedic device
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Jun 2011
Decision
77d
Days
Class 2
Risk

K110927 is an FDA 510(k) clearance for the MECTALIF. 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 June 13, 2011 after a review of 77 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medacta International devices

Submission Details

510(k) Number K110927 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 2011
Decision Date June 13, 2011
Days to Decision 77 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
45d faster than avg
Panel avg: 122d · This submission: 77d
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 610
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K110927.
CAPSTONE R SPINAL SYSTEM
K103731 · Medtronic Sofamor Danek · Jul 2011
PLATEAU SPACER SYSTEM
K111569 · Life Spine · Jul 2011
ALEUTIAN SPACER SYSTEM
K110843 · K2m, Inc. · Jun 2011
SPINEOLOGY PEEK LUMBAR INTERBODY FUSION DEVICE
K110933 · Spineology, Inc. · Jun 2011
FORZA SPACER SYSTEM
K103111 · Orthofix, Inc. · Mar 2011
CALIBER SPACER
K102293 · Globus Medical, Inc. · Jan 2011