Cleared Traditional

K153273 - MySpine Pedicle Screw Placement Guides ...

K153273 is the FDA 510(k) clearance for MySpine Pedicle Screw Placement Guides ... by Medacta International S.A.. It is a Class 2 Orthopedic device (product code MNI) cleared through the Traditional 510(k) pathway after a 230-day FDA review.

K153273 · Medacta International S.A. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2016
Decision
230d
Days
Class 2
Risk

K153273 is an FDA 510(k) clearance for the MySpine Pedicle Screw Placement Guides - LP. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by Medacta International S.A. (Castel San Pietro, CH). The FDA issued a Cleared decision on June 29, 2016 after a review of 230 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 S.A. devices

Submission Details

510(k) Number K153273 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 2015
Decision Date June 29, 2016
Days to Decision 230 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
108d slower than avg
Panel avg: 122d · This submission: 230d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Consultant

Mapi USA, Inc.
Roshana Ahmed

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K153273.
Sniper (R) Spine System
K160003 · Spine Wave, Inc. · Feb 2016
X-spine Pedicle Screw System
K152132 · X-Spine Systems, Inc. · Sep 2015
Sniper Spine System
K152174 · Spine Wave, Inc. · Aug 2015
Sniper Spine System
K151813 · Spine Wave, Inc. · Jul 2015
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM PREBENT CROSS-CONNECTORS
K141835 · Spineart · Sep 2014
MYSPINE PEDICLE SCREW PLACEMENT GUIDES
K132788 · Medacta International · May 2014