Cleared Special

K253024 - ProZip Knotless Implant (FDA 510(k) Clearance)

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

K253024 · Riverpoint Medical · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2025
Decision
27d
Days
Class 2
Risk

K253024 is an FDA 510(k) clearance for the ProZip Knotless Implant. Classified as Suture, Nonabsorbable, Synthetic, Polyethylene (product code GAT), Class II - Special Controls.

Submitted by Riverpoint Medical (Portland, US). The FDA issued a Cleared decision on October 16, 2025 after a review of 27 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5000 - the FDA general and plastic surgery device 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 Riverpoint Medical devices

Submission Details

510(k) Number K253024 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 2025
Decision Date October 16, 2025
Days to Decision 27 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 114d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code GAT Suture, Nonabsorbable, Synthetic, Polyethylene
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5000
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GAT Suture, Nonabsorbable, Synthetic, Polyethylene

All 172
Devices cleared under the same product code (GAT) and FDA review panel - the closest regulatory comparables to K253024.
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K253145 · Rti Surgical, Inc. · Oct 2025
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K252201 · Riverpoint Medical · Aug 2025
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K242201 · Threadstone, LLC · Mar 2025