Cleared Special

K100122 - MODIFICATION TO CAPSURE PS SYSTEM

K100122 is an FDA 510(k) clearance for MODIFICATION TO CAPSURE PS SYSTEM, manufactured by Spine Wave, Inc.. The device is a Class 2 Orthopedic device with product code MNH cleared through the Special 510(k) pathway after a 28-day FDA review.

K100122 · Spine Wave, Inc. · Orthopedic device
Download Printable Device Report (PDF)
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Feb 2010
Decision
28d
Days
Class 2
Risk

K100122 is an FDA 510(k) clearance for the MODIFICATION TO CAPSURE PS SYSTEM. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Spine Wave, Inc. (Shelton, US). The FDA issued a Cleared decision on February 12, 2010 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

FDA 510(k) Submission Details - K100122

510(k) Number K100122 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 15, 2010
Decision Date February 12, 2010
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.

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 278
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K100122.
VENUS BASIC SPINAL FIXATION SYSTEM
K100706 · L & K Biomed Co., Ltd. · Jul 2010
MIS SYSTEM
K100605 · Spine Wave, Inc. · Jun 2010
MODIFICATION TO: OASYS SYSTEM
K093670 · Stryker Spine · Mar 2010
PERFIX SPINAL SYSTEM, MODEL SNA4530-9610, SNM4530-9610, SN3020 (TOTAL: 549)
K091725 · U&I Corp. · Nov 2009
NORM SPINAL SYSTEM
K092011 · Norm Tibbi Urunler Ithalat Ihracat Sanayi VE Ticar · Oct 2009
ULC SPINAL PEDICLE SCREW SYSTEM
K083077 · Otis Biotech Co., Ltd. · Oct 2009