Cleared Special

K251648 - GPS Advanced (FDA 510(k) Clearance)

Also includes:
GPS Advanced Cannula

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

K251648 · Prosidyan, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2025
Decision
26d
Days
Class 2
Risk

K251648 is an FDA 510(k) clearance for the GPS Advanced. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Prosidyan, Inc. (New Providence, US). The FDA issued a Cleared decision on June 24, 2025 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 880.5860 - 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Prosidyan, Inc. devices

Submission Details

510(k) Number K251648 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 2025
Decision Date June 24, 2025
Days to Decision 26 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
96d faster than avg
Panel avg: 122d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code FMF Syringe, Piston
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
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

DePuy Synthes
Karin McDonough

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.

Regulatory Peers - FMF Syringe, Piston

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