Cleared Traditional

K231483 - MySpine Unilateral Guides (FDA 510(k) Clearance)

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

K231483 · Medacta International S.A. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2023
Decision
59d
Days
Class 2
Risk

K231483 is an FDA 510(k) clearance for the MySpine Unilateral Guides. Classified as Pedicle Screw Placement Guide (product code PQC), Class II - Special Controls.

Submitted by Medacta International S.A. (Castel San Pietro, CH). The FDA issued a Cleared decision on July 21, 2023 after a review of 59 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 K231483 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 2023
Decision Date July 21, 2023
Days to Decision 59 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
63d faster than avg
Panel avg: 122d · This submission: 59d
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 Consultant

Medacta USA
Christopher 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.