Cleared Traditional

K050078 - ROC LUMBAR PLATING SYSTEM

K050078 is an FDA 510(k) clearance for ROC LUMBAR PLATING SYSTEM, manufactured by Alphatec/Nexmed. The device is a Class 2 Orthopedic device with product code MNH cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K050078 · Alphatec/Nexmed · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2005
Decision
36d
Days
Class 2
Risk

K050078 is an FDA 510(k) clearance for the ROC LUMBAR PLATING SYSTEM. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Alphatec/Nexmed (Carlsbad, US). The FDA issued a Cleared decision on February 18, 2005 after a review of 36 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - 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 Alphatec/Nexmed devices

FDA 510(k) Submission Details - K050078

510(k) Number K050078 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 2005
Decision Date February 18, 2005
Days to Decision 36 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
86d faster than avg
Panel avg: 122d · This submission: 36d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MNH Device Classification - Class 2, Special Controls

Product Code MNH Orthosis, Spondylolisthesis Spinal Fixation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
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 - MNH Orthosis, Spondylolisthesis Spinal Fixation

All 218
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K050078.
4CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEM
K050471 · Solco Biomedical Co., Ltd. · May 2005
THE 4CIS SPINAL SYSTEM AND 4CIS LOW BACK SYSTEM
K043578 · Solco Biomedical Co., Ltd. · Mar 2005
STRYKER SPINE TRIO PS
K043180 · Stryker Spine · Mar 2005
MODIFICATION TO: CD HORIZON SPINAL SYSTEM
K043343 · Medtronic Sofamor Danek · Dec 2004
PROTEX STABILIZATION SYSTEM
K040442 · Globus Medical, Inc. · May 2004
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K034056 · Medtronic Sofamor Danek · Apr 2004