ProZip Knotless Implant— 510(k) K253024

Name: FDA 510(k) clearance K253024
Creator: U.S. Food and Drug Administration
Published: 2025-10-16

Substantially Equivalent

Riverpoint Medical

FDA 510(k) clearance K253024 for ProZip Knotless Implant, Substantially Equivalent on 2025-10-16. Applicant: Riverpoint Medical. Device class: 2.

Clearance details

Applicant: Riverpoint Medical
Product code: Code GAT
Device class: Class 2
Regulation: 21 CFR 878.5000
Advisory panel: General, Plastic Surgery
Date received: 2025-09-19
Decision date: 2025-10-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Portland, OR, US

Download summary PDF View on FDA.gov ↗

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K260775 — Polyethylene; Polyethylene Fusion; Polyethylene OrthoTape2026-05-06
K254275 — HyperSuture All Green Extension Line2026-03-23
K254188 — Meniscus Versaflex2026-02-19

More clearances from Riverpoint Medical

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K262677 — Iconix Knotless T2026-08-27
K252201 — HS Fiber2025-08-13
K252144 — Iconix Speed Anchor; Iconix Speed HA+ Anchor2025-07-30
K243323 — Iconix Knotless Anchor2024-11-19
K243203 — OC JuggerKnotless Soft Anchor; OC JuggerLoop Soft Anchor2024-10-29

Adverse events under product code GAT

product code GAT

Death: 19
Injury: 4,163
Malfunction: 8,646
Other: 2
Total: 12,830

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.