Cleared Traditional

K032855 - STRYKER SPINE MAPS SYSTEM

K032855 is an FDA 510(k) clearance for STRYKER SPINE MAPS SYSTEM, manufactured by Howmedica Osteonics. The device is a Class 2 Orthopedic device with product code MNH cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K032855 · Howmedica Osteonics · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2003
Decision
89d
Days
Class 2
Risk

K032855 is an FDA 510(k) clearance for the STRYKER SPINE MAPS SYSTEM. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Howmedica Osteonics (Allendale, US). The FDA issued a Cleared decision on December 10, 2003 after a review of 89 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 Howmedica Osteonics devices

FDA 510(k) Submission Details - K032855

510(k) Number K032855 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 2003
Decision Date December 10, 2003
Days to Decision 89 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
33d faster than avg
Panel avg: 122d · This submission: 89d
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 189
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K032855.
NUVASIVE SPINAL SYSTEM
K033546 · Nuvasive, Inc. · Apr 2004
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K040072 · Medtronic Sofamor Danek, Inc. · Feb 2004
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K033322 · Medtronic Sofamor Danek · Dec 2003
ORIA CLARIS
K023378 · Ortho Tec, LLC · Jun 2003
EBI P148 SPINAL FIXATION SYSTEM
K031423 · Ebi, L.P. · Jun 2003
BLACKSTONE SPINAL FIXATION SYSTEM LATERAL OFFSET (SYSTEM MODIFICATION)
K030581 · Blackstone Medical, Inc. · Jun 2003