Cleared Traditional

K120646 - CAPSURE(R) PS SYSTEM

K120646 is an FDA 510(k) clearance for CAPSURE PS SYSTEM, manufactured by Spine Wave, Inc.. The device is a Class 2 Orthopedic device with product code MNI cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K120646 · Spine Wave, Inc. · Orthopedic device
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Jun 2012
Decision
97d
Days
Class 2
Risk

K120646 is an FDA 510(k) clearance for the CAPSURE(R) 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 June 7, 2012 after a review of 97 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Spine Wave, Inc. devices

FDA 510(k) Submission Details - K120646

510(k) Number K120646 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 2012
Decision Date June 07, 2012
Days to Decision 97 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
25d faster than avg
Panel avg: 122d · This submission: 97d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MNI Device Classification - Class 2, Special Controls

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 265
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K120646.
CAPSURE(R) PS SYSTEM
K122233 · Spine Wave, Inc. · Oct 2012
4CIS VANE SPINE SYSTEM
K121615 · Solco Biomedical Co., Ltd. · Aug 2012
REFORM PEDICLE SCREW SYSTEM
K121172 · Spinal USA · Aug 2012
RANGE SPINAL SYSTEM, UNIT ROD
K120899 · K2m, Inc. · May 2012
LEXUS CERVICAL FIXATION SYSTEM
K120879 · L & K Biomed Co., Ltd. · May 2012
RANGE SPINAL SYSTEM (MESA AND DENALI)
K120099 · K2m, Inc. · May 2012