DeviceClearance

LigaMend— 510(k) K253695

Substantially Equivalent

Riverpoint Medical, LLC

FDA 510(k) clearance K253695 for LigaMend, Substantially Equivalent on 2026-02-27. Applicant: Riverpoint Medical, LLC. Device class: 2.

Summary

Riverpoint Medical's LigaMend is filed under product code MBI, nondegradable soft tissue fixation fastener. The record doesn't describe it beyond the name and that code name.

Class II, 21 CFR 888.3040. Orthopedic is both the classification panel and the review panel. It came in as a Traditional 510(k).

Riverpoint Medical filed from Portland, Oregon. FDA found it substantially equivalent 98 calendar days after receipt (November 21, 2025 to February 27, 2026).

Clearance details

Applicant
Riverpoint Medical, LLC
Product code
Product code MBI
Device class
Class 2
Regulation
21 CFR 888.3040
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Portland, OR, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code MBI

product code MBI
Injury
3,163
Malfunction
13,006
Other
2
Total
16,171

Source: openFDA MAUDE database, through . 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.