DeviceClearance

Arthrex Bioabsorbable PushLock Suture Anchors— 510(k) K253931

Substantially Equivalent

Arthrex, Inc.

FDA 510(k) clearance K253931 for Arthrex Bioabsorbable PushLock Suture Anchors, Substantially Equivalent on 2026-05-28. Applicant: Arthrex, Inc.. Device class: 2.

Summary

Arthrex's Bioabsorbable PushLock Suture Anchors are filed under MAI, biodegradable soft tissue fixation fasteners.

Class II, 21 CFR 888.3030. Orthopedic is both the classification panel and the review panel. It came in as a Traditional 510(k).

Arthrex filed from Naples, Florida. The decision came 170 calendar days after receipt (December 9, 2025 to May 28, 2026).

Clearance details

Applicant
Arthrex, Inc.
Product code
Product code MAI
Device class
Class 2
Regulation
21 CFR 888.3030
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Naples, FL, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code MAI

product code MAI
Injury
1,948
Malfunction
8,580
Total
10,528

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.