Cleared Special

K102235 - MANTIS SPINAL SYSTEM & MANTIS REDUX SPINAL SYSTEM

K102235 is an FDA 510(k) clearance for MANTIS SPINAL SYSTEM & MANTIS REDUX SPI..., manufactured by Stryker Spine. The device is a Class 2 Orthopedic device with product code NKB cleared through the Special 510(k) pathway after a 15-day FDA review.

K102235 · Stryker Spine · Orthopedic device
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Aug 2010
Decision
15d
Days
Class 2
Risk

K102235 is an FDA 510(k) clearance for the MANTIS SPINAL SYSTEM & MANTIS REDUX SPINAL SYSTEM. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Stryker Spine (Allendale, US). The FDA issued a Cleared decision on August 24, 2010 after a review of 15 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Stryker Spine devices

FDA 510(k) Submission Details - K102235

510(k) Number K102235 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 2010
Decision Date August 24, 2010
Days to Decision 15 days
Submission Type Special
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
107d faster than avg
Panel avg: 122d · This submission: 15d
Pathway characteristics
Modification to existing cleared device.

NKB Device Classification - Class 2, Special Controls

Product Code NKB Thoracolumbosacral Pedicle Screw System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
Definition Intended To Provide Immobilization And Stabilization Of Spinal Segments In Thoracic, Lumbar, And Sacral Spine As An Adjunct To Fusion.
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 - NKB Thoracolumbosacral Pedicle Screw System

All 890
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K102235.
CD HORIZON SPINAL SYSTEM
K091445 · Medtronic Sofamor Danek · Sep 2010
PATHFINDER II, MINIMALLY INVASIE PEDICLE SCREW SYSTEM MODEL 3500 SERIES
K100845 · Zimmer Spine, Inc. · Sep 2010
EXPEDIUM SPINE SYSTEM
K101070 · Medos International SARL · Aug 2010
STAINLESS STEEL SPINAL SYSTEM
K100970 · Theken Spine, LLC · Aug 2010
QUANTUM/ STREAMLINE SPINAL SYSTEM MODEL 02-SERIES AND 10-SERIES
K093692 · Pioneer Surgical Technology · Aug 2010
LANX SPINAL FIXATION SYSTEM
K100935 · Lanx, Inc. · Aug 2010