Cleared Special

K132154 - CAPSURE PS SYSTEM

K132154 is the FDA 510(k) clearance for CAPSURE PS SYSTEM by Spine Wave, Inc.. It is a Class 2 Orthopedic device (product code MNI) cleared through the Special 510(k) pathway after a 28-day FDA review.

K132154 · Spine Wave, Inc. · Orthopedic device
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Aug 2013
Decision
28d
Days
Class 2
Risk

K132154 is an FDA 510(k) clearance for the CAPSURE PS 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 August 9, 2013 after a review of 28 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 K132154 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 2013
Decision Date August 09, 2013
Days to Decision 28 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
94d faster than avg
Panel avg: 122d · This submission: 28d
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 159
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K132154.
EVEREST SPINAL SYSTEM
K132757 · K2m, Inc. · Nov 2013
EVEREST SPINAL SYSTEM
K132361 · K2m, Inc. · Oct 2013
LOSPA IS PEDICLE SCREW (MONOAXIAL & POLYAXIAL), LOSPA IS ROD- STRAIGHT (STANDARD), LOSPA IS ROD- PRE BENT (STANDARD & BU
K132644 · Corentec Co., Ltd. · Sep 2013
CERTEX SPINAL IMPLANT SYSTEM
K122163 · X-Spine Systems, Inc. · Oct 2012
CAPSURE(R) PS SYSTEM
K122233 · Spine Wave, Inc. · Oct 2012
CAPSURE(R) PS SYSTEM
K120646 · Spine Wave, Inc. · Jun 2012