Align Radial Head System— 510(k) K172688

Name: FDA 510(k) clearance K172688
Creator: U.S. Food and Drug Administration
Published: 2017-12-22

Substantially Equivalent

Skeletal Dynamics, LLC

FDA 510(k) clearance K172688 for Align Radial Head System, Substantially Equivalent on 2017-12-22. Applicant: Skeletal Dynamics, LLC. Device class: 2.

Clearance details

Applicant: Skeletal Dynamics, LLC
Product code: Code KWI
Device class: Class 2
Regulation: 21 CFR 888.3170
Advisory panel: Orthopedic
Date received: 2017-09-06
Decision date: 2017-12-22
Decision: Substantially Equivalent
Clearance type: Special
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
K231188 — ALIGN Radial Head System2023-09-28
K213563 — DePuy Synthes Radial Head Replacement System2022-03-18
K212872 — Avenger Radial Head System2021-12-17

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K150675 — Dorsal Spanning Plate2015-05-12

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.