Cleared Traditional

K171369 - M.U.S.T. MINI Posterior Cervical Screws...

K171369 is the FDA 510(k) clearance for M.U.S.T. MINI Posterior Cervical Screws... by Medacta International S.A.. It is a Class 2 Orthopedic device (product code NKG) cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K171369 · Medacta International S.A. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Aug 2017
Decision
83d
Days
Class 2
Risk

K171369 is an FDA 510(k) clearance for the M.U.S.T. MINI Posterior Cervical Screws System. Classified as Posterior Cervical Screw System (product code NKG), Class II - Special Controls.

Submitted by Medacta International S.A. (Castel San Pietro (Ch), CH). The FDA issued a Cleared decision on August 1, 2017 after a review of 83 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3075 - 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 K171369 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 2017
Decision Date August 01, 2017
Days to Decision 83 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
39d faster than avg
Panel avg: 122d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NKG Posterior Cervical Screw System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3075
Definition Posterior Cervical Screw Systems Are Intended For Use In Fusion Procedures Of The Cervical Spine And/or Craniocervical Junction And/or Cervicothoracic Junction For: 1) Spinal Fractures And Dislocations; 2) Deformities; 3) Instabilities; 4) Failed Previous Fusions; 5) Tumors; 6) Inflammatory Disorders; 7) Spinal Degeneration, 8) Facet Degeneration With Instability; And 9) Reconstruction Following Decompression To Treat Radiculopathy And/or Myelopathy. These Systems Are Also Intended To Stabilize The Spine In The Absence Of Fusion For A Limited Time Period In Patients With Tumors Involving The Cervical Spine In Whom Life Expectancy Is Of Insufficient Duration To Permit Achievement Of 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, MST, RAC

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 - NKG Posterior Cervical Screw System

All 96
Devices cleared under the same product code (NKG) and FDA review panel - the closest regulatory comparables to K171369.
INFINITY™ OCT System
K163375 · Medtronic Sofamor Danek USA, Inc. · Aug 2017
Connector System
K172194 · Orthofix, Inc. · Aug 2017
YUKON OCT Spinal System
K171444 · K2m, Inc. · Aug 2017
The Solstice OCT System
K170804 · Life Spine, Inc. · May 2017
Connector System
K170647 · Orthofix, Inc. · May 2017
The Cranial Fusion System
K162266 · Life Spine, Inc. · May 2017