Cleared Traditional

K043180 - STRYKER SPINE TRIO PS

K043180 is the FDA 510(k) clearance for STRYKER SPINE TRIO PS by Stryker Spine. It is a Class 2 Orthopedic device (product code MNH) cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K043180 · Stryker Spine · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2005
Decision
105d
Days
Class 2
Risk

K043180 is an FDA 510(k) clearance for the STRYKER SPINE TRIO PS. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Stryker Spine (Allendale, US). The FDA issued a Cleared decision on March 2, 2005 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 888.3070 - 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: 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 Stryker Spine devices

Submission Details

510(k) Number K043180 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 2004
Decision Date March 02, 2005
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 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 156
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K043180.
ZODIAC ADJUSTABLE BRIDGES, MODELS 11-20XX,11-25XX,11-30XX,11-35XX
K061321 · Alphatec Spine, Inc. · Jul 2006
NUVASIVE SPHERX SYSTEM
K060225 · Nuvasive, Inc. · Apr 2006
XIA 4.5 SPINAL SYSTEM
K050461 · Stryker Spine · Jul 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