Arthrex Radial Head Replacement System— 510(k) K260624

Name: FDA 510(k) clearance K260624
Creator: U.S. Food and Drug Administration
Published: 2026-07-30

Substantially Equivalent

Arthrex, Inc.

FDA 510(k) clearance K260624 for Arthrex Radial Head Replacement System, Substantially Equivalent on 2026-07-30. Applicant: Arthrex, Inc.. Device class: 2.

Clearance details

Applicant: Arthrex, Inc.
Product code: Code KWI
Device class: Class 2
Regulation: 21 CFR 888.3170
Advisory panel: Orthopedic
Date received: 2026-02-26
Decision date: 2026-07-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Naples, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KWI

view all

K233592 — BioPoly Radial Head Implant2024-03-13
K231188 — ALIGN Radial Head System2023-09-28
K213563 — DePuy Synthes Radial Head Replacement System2022-03-18
K212872 — Avenger Radial Head System2021-12-17
K192754 — Avenger Radial Head System2020-01-07

More clearances from Arthrex, Inc.

view all

K262357 — Arthrex Bioabsorbable PushLock Suture Anchors2026-08-07
K260018 — Arthrex FiberButton2026-06-26
K260809 — Arthrex Sterile VAL and VAL KreuLock Compression Screw System2026-06-25
K253931 — Arthrex Bioabsorbable PushLock Suture Anchors2026-05-28
K254215 — Arthrex Beaming System2026-05-08

Adverse events under product code KWI

product code KWI

Injury: 490
Total: 490

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.