Cleared Special

K203673 - MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC and Drill Pilot Guides, and MySpine S2-Alar/Alar Iliac Guides) (FDA 510(k) Clearance)

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K203673 · Medacta International S.A. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2021
Decision
111d
Days
Class 2
Risk

K203673 is an FDA 510(k) clearance for the MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides,.... Classified as Pedicle Screw Placement Guide (product code PQC), Class II - Special Controls.

Submitted by Medacta International S.A. (Castel San Pietro (Ch), CH). The FDA issued a Cleared decision on April 6, 2021 after a review of 111 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - 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. Standard predicate reliance. 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 K203673 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 2020
Decision Date April 06, 2021
Days to Decision 111 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
11d faster than avg
Panel avg: 122d · This submission: 111d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code PQC Pedicle Screw Placement Guide
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
Definition A Pedicle Screw Placement Guide Is Intended To Be Used As A Surgical Instrument To Assist In The Intra-operative Placement Of Pedicle Screws That Are Used To Anchor Pedicle Screw Spinal Systems Onto The Posterior Elements Of The Spine. The Device Utilizes Anatomic Landmarks That Are Identifiable On Pre-operative Imaging Scans.
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.