ALIGN RADIAL HEAD SYSTEM— 510(k) K092721

Clearance details

Applicant

Skeletal Dynamics, LLC

Product code

Code KWI

Device class

Class 2

Regulation

21 CFR 888.3170

Advisory panel

Orthopedic

Date received

2009-09-04

Decision date

2010-08-03

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Shelton, CT, US

• 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

• K182492 — Geminus Volar Distal Radius Plate System2018-10-10
• K180744 — Stablyx CMC Arthroplasty Implant System2018-04-11
• K172688 — Align Radial Head System2017-12-22
• K171590 — Distal Elbow Plating System2017-06-27
• K153208 — Internal Joint Stabilizer - Elbow2015-12-31

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 →

• Z-0582-2015 — Align Radial Stems, Prosthesis, Elbow, Hemi Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with: Joint destruction and/or subluxation and resistance to conservative treatment. Intended use is also for primary replacement after fracture of the radial head and symptomatic sequelae after radial head resection.Class II·Terminated·Skeletal Dynamics·20141016

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K092721.