Cleared Special

CAPSURE PS (R) SPINE SYSTEM (K081228) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K081228 · Spine Wave, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2008
Decision
12d
Days
Class 2
Risk

K081228 is an FDA 510(k) clearance for the CAPSURE PS (R) SPINE SYSTEM. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by Spine Wave, Inc. (Shelton, US). The FDA issued a Cleared decision on May 12, 2008 after a review of 12 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 Spine Wave, Inc. devices

Submission Details

510(k) Number K081228 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2008
Decision Date May 12, 2008
Days to Decision 12 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
110d faster than avg
Panel avg: 122d · This submission: 12d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MNI Orthosis, Spinal Pedicle 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 - MNI Orthosis, Spinal Pedicle Fixation

All 30
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K081228.
MySpine Pedicle Screw Placement Guides - LP
K153273 · Medacta International S.A. · Jun 2016
EXACTECH GIBRALT SPINAL SYSTEM
K110197 · Exactech, Inc. · Jul 2011
CD HORIZON SPINAL SYSTEM
K062606 · Medtronic Sofamor Danek · Sep 2006
MODIFICATION TO S4 SPINAL SYSTEM
K060152 · Aesculap, Inc. · Feb 2006
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
K053483 · Medtronic Sofamor Danek · Jan 2006
S4 SPINAL SYSTEM
K050979 · Aesculap, Inc. · Jul 2005