ALIGN Radial Head System— 510(k) K231188

Name: FDA 510(k) clearance K231188
Creator: U.S. Food and Drug Administration
Published: 2023-09-28

Substantially Equivalent

Skeletal Dynamics, Inc.

FDA 510(k) clearance K231188 for ALIGN Radial Head System, Substantially Equivalent on 2023-09-28. Applicant: Skeletal Dynamics, Inc.. Device class: 2.

Clearance details

Applicant: Skeletal Dynamics, Inc.
Product code: Code KWI
Device class: Class 2
Regulation: 21 CFR 888.3170
Advisory panel: Orthopedic
Date received: 2023-04-26
Decision date: 2023-09-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KWI

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K260624 — Arthrex Radial Head Replacement System2026-07-30
K233592 — BioPoly Radial Head Implant2024-03-13
K213563 — DePuy Synthes Radial Head Replacement System2022-03-18
K212872 — Avenger Radial Head System2021-12-17
K192754 — Avenger Radial Head System2020-01-07

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K243381 — Total Wrist Arthroplasty System (TWA)2024-11-01

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.