Cleared Traditional

K132788 - MYSPINE PEDICLE SCREW PLACEMENT GUIDES

K132788 is an FDA 510(k) clearance for MYSPINE PEDICLE SCREW PLACEMENT GUIDES, manufactured by Medacta International. The device is a Class 2 Orthopedic device with product code MNI cleared through the Traditional 510(k) pathway after a 259-day FDA review.

K132788 · Medacta International · Orthopedic device
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May 2014
Decision
259d
Days
Class 2
Risk

K132788 is an FDA 510(k) clearance for the MYSPINE PEDICLE SCREW PLACEMENT GUIDES. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by Medacta International (Camarillo, US). The FDA issued a Cleared decision on May 23, 2014 after a review of 259 days - an extended review cycle.

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 Medacta International devices

FDA 510(k) Submission Details - K132788

510(k) Number K132788 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 2013
Decision Date May 23, 2014
Days to Decision 259 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
137d slower than avg
Panel avg: 122d · This submission: 259d
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 259
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K132788.
PASS LP SPINAL SYSTEM
K140738 · Medicrea International · Nov 2014
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM PREBENT CROSS-CONNECTORS
K141835 · Spineart · Sep 2014
SURE-LOK C EXTENDED TAB PEDICLE SCREW SYSTEM
K141397 · Precision Spine, Inc. · Jun 2014
GENERAL SPINAL SYSTEM
K140229 · Tianjin Walkman Biomaterial Co., Ltd. · Apr 2014
AVERSION PEDICLE SCREW SYSTEM
K133103 · K7, LLC · Jan 2014
MIKRON SPINAL FIXATION SYSTEM, POLYXIAL PEDICLE SCREWS, SET SCREWS, LONGITUDINAL RODS
K130073 · Mikron Makina Sanayi VE Ticaret Ltd. Sti. · Dec 2013