Cleared Traditional

K241895 - Cannulated PsiFGuard (FDA 510(k) Clearance)

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

K241895 · Spineguard · Orthopedic device
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Sep 2024
Decision
90d
Days
Class 2
Risk

K241895 is an FDA 510(k) clearance for the Cannulated PsiFGuard. Classified as Sacroiliac Joint Guidewire Placement Device (product code SCY), Class II - Special Controls.

Submitted by Spineguard (Vincennes, FR). The FDA issued a Cleared decision on September 26, 2024 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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 Spineguard devices

Submission Details

510(k) Number K241895 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 2024
Decision Date September 26, 2024
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code SCY Sacroiliac Joint Guidewire Placement Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
Definition A Sacroiliac Joint Guidewire Placement Device Is Intended To Be Used To Assist In Locating The Sacroiliac Joint And Placing A Guidewire In The Joint As Part Of Sacroiliac Joint Fusion Surgeries To Place Implants Into The Sacroiliac Joint.
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

Hogan Lovells US LLP
John Smith

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.