Cleared Traditional

K112862 - MECTA-C

K112862 is an FDA 510(k) clearance for MECTA-C, manufactured by Medacta International. The device is a Class 2 Orthopedic device with product code ODP cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K112862 · Medacta International · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2011
Decision
80d
Days
Class 2
Risk

K112862 is an FDA 510(k) clearance for the MECTA-C. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Medacta International (Camarillo, US). The FDA issued a Cleared decision on December 19, 2011 after a review of 80 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

FDA 510(k) Submission Details - K112862

510(k) Number K112862 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2011
Decision Date December 19, 2011
Days to Decision 80 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
42d faster than avg
Panel avg: 122d · This submission: 80d
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 336
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K112862.
ECLIPSE VERTEBRAL SPACER SYSTEM-CERVICAL
K120143 · Apollo Spine · Feb 2012
LDR SPINE CERVICAL INTERBODY FUSION SYSTME-ROI-C LORDOTIC IMPLANTS
K113559 · Ldr Spine USA, Inc. · Dec 2011
ZAVATION IBF SYSTEMS
K112664 · Zavation, LLC · Dec 2011
VARILIFT CERVICAL INTERBODY FUSION SYSTEM
K111123 · Wenzel Spine · Dec 2011
ALAMO C
K112361 · Alliance Partners, LLC · Nov 2011
TRABECULAR METAL (TM) FUSION DEVICE
K111119 · Zimmer Spine, Inc. · Nov 2011