Cleared Traditional

K042640 - UNI-THREAD SPINAL SYSTEM

K042640 is an FDA 510(k) clearance for UNI-THREAD SPINAL SYSTEM, manufactured by Spine Vision, Inc.. The device is a Class 2 Orthopedic device with product code MNH cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K042640 · Spine Vision, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2004
Decision
57d
Days
Class 2
Risk

K042640 is an FDA 510(k) clearance for the UNI-THREAD SPINAL SYSTEM. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Spine Vision, Inc. (Atlanta, US). The FDA issued a Cleared decision on November 23, 2004 after a review of 57 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 Spine Vision, Inc. devices

FDA 510(k) Submission Details - K042640

510(k) Number K042640 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2004
Decision Date November 23, 2004
Days to Decision 57 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
65d faster than avg
Panel avg: 122d · This submission: 57d
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 K042640.
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
NUVASIVE SPINAL SYSTEM
K033546 · Nuvasive, Inc. · Apr 2004