# I.T.S. GmbH

- Location (FDA's records): Laßnitzhöhe, AT
- FDA decisions: 8 (2013–2026): 8 510(k) clearances
- Product codes: HRS (6), HSB (2)
- 510(k) review time since 2016: median 122 days, against 113 for FDA's reviews in the same codes and years (1 of 4 faster)
- Predicates its devices cite: 81 (8 its own); citations of its devices by later devices: 16 (8 its own)
- Recalls linked to its devices: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- I.T.S. Implantat-Technologie-Systeme GmbH: 16 (https://510kreport.com/company/its-implantat-technologie-systeme)
- Howmedica Osteonics Corp.: 11 (https://510kreport.com/company/howmedica-osteonics)
- Synthes (Usa): 8 (https://510kreport.com/company/synthes-usa)
- Acumed, LLC: 4 (https://510kreport.com/company/acumed)
- Zimmer, Inc.: 3 (https://510kreport.com/company/zimmer)
- Acu Med, Inc.: 3 (https://510kreport.com/company/acu-med)
- Stryker Trauma AG: 2 (https://510kreport.com/company/stryker-trauma)
- Hand Innovations, Inc.: 2 (https://510kreport.com/company/hand-innovations)

## Firms that cite its devices most
- Synchro Medical: 1 (https://510kreport.com/company/synchro-medical)
- Syntec Scientific Corp.: 1 (https://510kreport.com/company/syntec-scientific)
- Smith & Nephew, Inc.: 1 (https://510kreport.com/company/smith-nephew)
- Treace Medical Concepts, Inc.: 1 (https://510kreport.com/company/treace-medical-concepts)
- Orthoxel: 1 (https://510kreport.com/company/orthoxel)
- Advanced Orthopaedic Solutions, Inc.: 1 (https://510kreport.com/company/advanced-orthopaedic-solutions)
- Eminent Spine: 1 (https://510kreport.com/company/eminent-spine)
- Ortho Solutions UK, Ltd.: 1 (https://510kreport.com/company/ortho-solutions-uk)

## Its most-cited devices
- K131722: I.T.S. Extremity Fixation Systems (2013), cited by 7
- K132945: CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral Nail (2014), cited by 4
- K210935: I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix) (2022), cited by 3
- K142418: I.T.S. Hand Locking Plates System - HLS (2014), cited by 1
- K130008: Distal Ulna Locking Plate (Dul), Ulna Osteotomy Locking Plate (Uol), 3.0 Cancellous Locking Screw, 3.0 Cortical Locking (2013), cited by 1

## Recent decisions
- 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 (Jun 16, 2026)
- K260054: I.T.S. PRS Phoenix II (Apr 24, 2026)
- K233134: I.T.S. INS Proximal Femur Nail (Feb 12, 2024)
- K210935: I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix) (Aug 31, 2022)
- K142418: I.T.S. Hand Locking Plates System - HLS (Sep 26, 2014)
- K132945: CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral Nail (Mar 7, 2014)
- K131722: I.T.S. Extremity Fixation Systems (Aug 7, 2013)
- K130008: Distal Ulna Locking Plate (Dul), Ulna Osteotomy Locking Plate (Uol), 3.0 Cancellous Locking Screw, 3.0 Cortical Locking (Jun 25, 2013)

Source page: https://510kreport.com/company/its