Cleared Traditional

K171170 - M.U.S.T. Pedicle Screw System Extension...

K171170 is the FDA 510(k) clearance for M.U.S.T. Pedicle Screw System Extension... by Medacta International S.A.. It is a Class 2 Orthopedic device (product code NKB) cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K171170 · Medacta International S.A. · Orthopedic device
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Optimized for regulatory review, auditing and printing
May 2017
Decision
34d
Days
Class 2
Risk

K171170 is an FDA 510(k) clearance for the M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional .... Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Medacta International S.A. (Castel San Pietro (Ch), CH). The FDA issued a Cleared decision on May 25, 2017 after a review of 34 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medacta International S.A. devices

Submission Details

510(k) Number K171170 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 2017
Decision Date May 25, 2017
Days to Decision 34 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
88d faster than avg
Panel avg: 122d · This submission: 34d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NKB Thoracolumbosacral Pedicle Screw System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
Definition Intended To Provide Immobilization And Stabilization Of Spinal Segments In Thoracic, Lumbar, And Sacral Spine As An Adjunct To Fusion.
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.
Elizabeth Rose

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 - NKB Thoracolumbosacral Pedicle Screw System

All 661
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K171170.
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K171082 · Orthofix, Inc. · May 2017