Cleared Special

K203671 - M.U.S.T. Sacral Iliac Screw and Pelvic ...

K203671 is the FDA 510(k) clearance for M.U.S.T. Sacral Iliac Screw and Pelvic ... by Medacta International S.A.. It is a Class 2 Orthopedic device (product code OUR) cleared through the Special 510(k) pathway after a 28-day FDA review.

K203671 · Medacta International S.A. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Jan 2021
Decision
28d
Days
Class 2
Risk

K203671 is an FDA 510(k) clearance for the M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System. Classified as Sacroiliac Joint Fixation (product code OUR), Class II - Special Controls.

Submitted by Medacta International S.A. (Castel San Pietro (Ch), CH). The FDA issued a Cleared decision on January 13, 2021 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Medacta International S.A. devices

Submission Details

510(k) Number K203671 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 2020
Decision Date January 13, 2021
Days to Decision 28 days
Submission Type Special
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
94d faster than avg
Panel avg: 122d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code OUR Sacroiliac Joint Fixation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
Definition Sacroiliac Joint 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

Medacta USA
Chris Lussier

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 - OUR Sacroiliac Joint Fixation

All 105
Devices cleared under the same product code (OUR) and FDA review panel - the closest regulatory comparables to K203671.
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K201664 · Orthofix, Inc. · Sep 2020