VOLAR RADIUS PLATE WITH ANGULAR STABILITY— 510(k) K033756

Clearance details

Applicant

I.T.S. Implantat-Technologie-Systeme GmbH

Product code

Code HRS

Device class

Class 2

Regulation

21 CFR 888.3030

Advisory panel

Orthopedic

Date received

2003-12-01

Decision date

2004-02-06

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Prior Lake, MN, US

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Death

27

Injury

10,340

Malfunction

3,328

Total

13,695

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-1592-2026 — Volar Radius Plate with Angular Stability with the following description: Radius Plate PROlock II. Article Numbers: 21031-3, 21031-5, 21032-11, 21032-3, 21032-5, 21033-3, 21033-5, 21034-3, 21034-5, 21035-3, 21036-3.Class II·Ongoing·I.T.S. GmbH·20260123

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K033756.