FIBULA PLATE PROLOCK WITH ANGULAR STABILITY— 510(k) K063672

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

2006-12-11

Decision date

2007-02-02

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Prior Lake, MN, US

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• K093868 — I.T.S. LRS LOCKING RECONSTRUCTION SYSTEM2010-08-05
• K080706 — CONNEXX LOCKING TIBIA NAIL2008-06-09
• K080184 — DISTAL HUMERAL PLATES WITH ANGULAR STABILITY2008-03-26
• K063166 — I.T.S. PELVIC RECONSTRUCTION SYSTEM2006-12-22
• K060156 — STRAIGHT PLATE WITH ANGULAR STABILITY & SCREW SYSTEM2006-03-20

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-1601-2026 — I.T.S. Fibula Plate PROlock with Angular Stability with the below descriptions and corresponding article numbers. 1. Distal Tubular Plate; Article Numbers: 21602-3, 21602-4, 21602-5, 21602-6, 21602-7, 21602-8, 21603-3, 21603-4, 21603-5, 21603-6, 21603-7, 21603-8. 2. Fibula Plate 3.5mm; Article Numbers: 21225-4, 21225-6, 21225-8, 21225-10, 21225-12, 21226-4, 21226-6, 21226-8, 21226-10, 21226-12. 3. Universal Tubular Plate; Article Numbers: 21601-5, 21601-6, 21601-7, 21601-8, 21601-10, 21601-12, 21601-14, 21601-16.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 K063672.