Cleared Traditional

K231515 - MySpine Cervical Guides (FDA 510(k) Clearance)

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

K231515 · Medacta International S.A. · Orthopedic device
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Dec 2023
Decision
196d
Days
Class 2
Risk

K231515 is an FDA 510(k) clearance for the MySpine Cervical Guides. Classified as Posterior Cervical Screw Placement Guide (product code QSD), Class II - Special Controls.

Submitted by Medacta International S.A. (Castel San Pietro, CH). The FDA issued a Cleared decision on December 7, 2023 after a review of 196 days - an extended review 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: 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 International S.A. devices

Submission Details

510(k) Number K231515 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 2023
Decision Date December 07, 2023
Days to Decision 196 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
74d slower than avg
Panel avg: 122d · This submission: 196d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QSD Posterior Cervical Screw Placement Guide
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3075
Definition A Posterior Cervical Screw Placement Guide Is Intended To Be Used As A Surgical Instrument To Assist In The Intra-operative Placement Of Posterior Cervical Screws That Are Used To Anchor Posterior Cervical Screw Systems On 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
Lussier Cristopher

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.