Chrysalis Intelligence · Sponsors · I.T.S. GmbH

I.T.S. GmbH

Laßnitzhöhe, AT · 4 510(k) clearances · 17 recalls

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Total clearances
4
2022-08-31 → 2026-06-16
Last 12 months
2
Product codes
2
Most recent
2026-06-16
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
HRS Plate, Fixation, Bone Class II Orthopedic 3 2026-06-16
HSB Rod, Fixation, Intramedullary And Accessories Class II Orthopedic 1 2024-02-12
Safety

Recalls (17)

Class I (serious)
0
Risk of injury / death
Total recalls
17
Currently ongoing
17
Most recent
2026-01-23
DateSeverityStatusRecall # ProductCodeReason
2026-01-23 Class II Ongoing Z-1608-2026 Brand Name: I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix) with the below descriptions and corresponding art… — Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for U…
2026-01-23 Class II Ongoing Z-1607-2026 HLS - Hand Locking Plates System with the below descriptions and corresponding article numbers. 1. Cortical Screw; A… — Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for U…
2026-01-23 Class II Ongoing Z-1606-2026 HCS - Headless Compression Screw System, Headless Compression Screw, Cannulated; Article Numbers: 31207-10, 31207-12, 31… — Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for U…
2026-01-23 Class II Ongoing Z-1605-2026 FLS - Foot Locking Plates System and HOL - Hallux Osteotomy Locking Plate with the below descriptions and corresponding … — Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for U…
2026-01-23 Class II Ongoing Z-1604-2026 I.T.S. DUL (Distal Ulna Locking) System and UOL (Ulna Osteotomy Locking) System with the below descriptions and correspo… — Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for U…
2026-01-23 Class II Ongoing Z-1603-2026 I.T.S. LRS (Locking Reconstruction System) with the below descriptions and corresponding article numbers. 1. DFL (Di… — Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for U…
2026-01-23 Class II Ongoing Z-1602-2026 Distal Humeral Plates with Angular Stability with the below descriptions and corresponding article numbers. 1. Corti… — Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for U…
2026-01-23 Class II Ongoing Z-1601-2026 I.T.S. Fibula Plate PROlock with Angular Stability with the below descriptions and corresponding article numbers. 1.… — Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for U…
2026-01-23 Class II Ongoing Z-1600-2026 Pelvic Reconstruction System (PRS) with the below descriptions and corresponding article numbers. 1. Fixation Screw;… — Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for U…
2026-01-23 Class II Ongoing Z-1599-2026 I.T.S. Screw System with the below descriptions and corresponding article numbers. 1. Cancellous Screw, Cannulated; … — Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for U…
2026-01-23 Class II Ongoing Z-1598-2026 I.T.S. Straight Plate with Angular Stability with the below descriptions and corresponding article numbers. 1. Forea… — Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for U…
2026-01-23 Class II Ongoing Z-1597-2026 Olecranonplate with Angular Stability with the below descriptions and corresponding article numbers. 1. Olecranon Hoo… — Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for U…
2026-01-23 Class II Ongoing Z-1596-2026 Pilonplate with Angular Stability, with the below descriptions and corresponding article numbers. 1. Anterolateral T… — Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for U…
2026-01-23 Class II Ongoing Z-1595-2026 FR.O.H. Calcaneus Repair System with the following description: Anterolateral Calcaneus Plate. Article Number: 21064-60. — Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for U…
2026-01-23 Class II Ongoing Z-1594-2026 Brand Name: Humeral Head Plate with Angular Stability, with the following description: Proximal Humeral Plate. Article N… — Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for U…
2026-01-23 Class II Ongoing Z-1593-2026 Claviculaplate with Angular Stability, with the below descriptions and associated article numbers. 1. Anterior Clavi… — Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for U…
2026-01-23 Class II Ongoing Z-1592-2026 Volar Radius Plate with Angular Stability with the following description: Radius Plate PROlock II. Article Numbers: 2103… — Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for U…
Filings

All 510(k) clearances (4)

Date K-number Device Code Class Specialty
2026-06-16 K260958 I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular Stability; I.T.S. Humeral Head Plate with Angular Stability; I.T.S. FR.O.H. Calcaneus Repair System; I.T.S. Pilonplate with Angular Stability; I.T.S. Olecranonplate with Angular Stability; I.T.S. Straight Plate with Angular Stability; I.T.S. Screw System; I.T.S. PRS Sacral Rod System; I.T.S. Fibula Plate PROlock with Angular Stability; I.T.S. Distal Humeral Plates with Angular Stability; I.T.S. LRS (L HRS Class II Orthopedic
2026-04-24 K260054 I.T.S. PRS Phoenix II HRS Class II Orthopedic
2024-02-12 K233134 I.T.S. INS Proximal Femur Nail HSB Class II Orthopedic
2022-08-31 K210935 I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix) HRS Class II Orthopedic
Data source: openFDA · Generated 2026-07-25 22:26 · Last ingest 2026-07-25T13:19:55.737268 · Pipeline: Chrysalis Intelligence