Cleared Traditional

K200792 - MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K200792 · Medacta Inernational SA · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2020
Decision
193d
Days
Class 2
Risk

K200792 is an FDA 510(k) clearance for the MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides. Classified as Pedicle Screw Placement Guide (product code PQC), Class II - Special Controls.

Submitted by Medacta Inernational SA (Castel San Pietro (Ch), CH). The FDA issued a Cleared decision on October 5, 2020 after a review of 193 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 Inernational SA devices

Submission Details

510(k) Number K200792 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 2020
Decision Date October 05, 2020
Days to Decision 193 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d slower than avg
Panel avg: 122d · This submission: 193d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Peers - PQC Pedicle Screw Placement Guide

All 7
Devices cleared under the same product code (PQC) and FDA review panel - the closest regulatory comparables to K200792.
FIREFLY® Pedicle Screw Navigation Guide
K253472 · Mighty Oak Medical · Feb 2026
MySpine Unilateral Guides
K231483 · Medacta International S.A. · Jul 2023
MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC and Drill Pilot Guides, and MySpine S2-Alar/Alar Iliac Guides)
K203673 · Medacta International S.A. · Apr 2021