Cleared Traditional

K061813 - MANTIS SPINAL SYSTEM

K061813 is the FDA 510(k) clearance for MANTIS SPINAL SYSTEM by Stryker Spine. It is a Class 2 Orthopedic device (product code MNH) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K061813 · Stryker Spine · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2006
Decision
84d
Days
Class 2
Risk

K061813 is an FDA 510(k) clearance for the MANTIS SPINAL SYSTEM. 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 September 19, 2006 after a review of 84 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 Stryker Spine devices

Submission Details

510(k) Number K061813 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 2006
Decision Date September 19, 2006
Days to Decision 84 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
38d faster than avg
Panel avg: 122d · This submission: 84d
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 154
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K061813.
CAPLESS LI PEDICLE SCREW SYSTEM
K072282 · X-Spine Systems, Inc. · Sep 2007
MODIFICATION TO EXPEDIUM SPINE SYSTEM
K062174 · Depuy Spine, Inc. · Nov 2006
ISS INTEGRATED SPINE SYSTEM
K061524 · Ortho Development Corp. · Sep 2006
SFX SNAP-FIT CROSS CONNECTOR
K062196 · Depuy Spine, Inc. · Sep 2006
PILOT POSTERIOR LUMBAR PLATING SYSTEM
K061364 · Life Spine · Sep 2006
MODIFICATION TO NUVASIVE SPHERX II SYSTEM
K062317 · Nuvasive, Inc. · Sep 2006