Cleared Traditional

K241426 - GPS Advanced (FDA 510(k) Clearance)

Also includes:
5 cc GPS Advanced Cannula

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

K241426 · Prosidyan, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2024
Decision
51d
Days
Class 2
Risk

K241426 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 July 10, 2024 after a review of 51 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. 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 Prosidyan, Inc. devices

Submission Details

510(k) Number K241426 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 2024
Decision Date July 10, 2024
Days to Decision 51 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
71d faster than avg
Panel avg: 122d · This submission: 51d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.

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