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

- Location (FDA's records): Prior Lake, MN
- FDA decisions: 13 (2004–2010): 13 510(k) clearances
- Product codes: HRS (10), JDS (1), HWC (1), NDF (1)
- Predicates its devices cite: 59 (5 its own); citations of its devices by later devices: 37 (5 its own)
- Recalls linked to its devices: 13 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Synthes (Usa): 23 (https://510kreport.com/company/synthes-usa)
- Zimmer, Inc.: 4 (https://510kreport.com/company/zimmer)
- Acu Med, Inc.: 4 (https://510kreport.com/company/acu-med)
- Acumed, LLC: 3 (https://510kreport.com/company/acumed)
- Ace Medical Co.: 3 (https://510kreport.com/company/ace-medical)
- Howmedica Osteonics Corp.: 3 (https://510kreport.com/company/howmedica-osteonics)
- Depuy Ace Medical Co.: 2 (https://510kreport.com/company/depuy-ace-medical)
- Smith & Nephew, Inc.: 2 (https://510kreport.com/company/smith-nephew)

## Firms that cite its devices most
- I.T.S. GmbH: 16 (https://510kreport.com/company/its)
- Surgtech, Inc.: 8 (https://510kreport.com/company/surgtech)
- Ascent Medical, LLC: 1 (https://510kreport.com/company/ascent-medical)
- Newclip Technics: 1 (https://510kreport.com/company/newclip-technics)
- Smith & Nephew, Inc.: 1 (https://510kreport.com/company/smith-nephew)
- Acumed, LLC: 1 (https://510kreport.com/company/acumed)
- Ortho Solutions Limited: 1 (https://510kreport.com/company/ortho-solutions)
- OrthoPediatrics Corp.: 1 (https://510kreport.com/company/orthopediatrics)

## Its most-cited devices
- K060156: Straight Plate with Angular Stability & Screw System (2006), cited by 7
- K063166: I.T.S. Pelvic Reconstruction System (2006), cited by 6
- K050852: Claviculaplate with Angular Stablity Bone Plate System (2005), cited by 4
- K051642: FR.O.H. Calcaneus Repair System (2005), cited by 4
- K080184: Distal Humeral Plates with Angular Stability (2008), cited by 3
- K063672: Fibula Plate Prolock with Angular Stability (2007), cited by 3

## Recent decisions
- K093868: I.T.S. LRS Locking Reconstruction System (Aug 5, 2010)
- K080706: Connexx Locking Tibia Nail (Jun 9, 2008)
- K080184: Distal Humeral Plates with Angular Stability (Mar 26, 2008)
- K063672: Fibula Plate Prolock with Angular Stability (Feb 2, 2007)
- K063166: I.T.S. Pelvic Reconstruction System (Dec 22, 2006)
- K060156: Straight Plate with Angular Stability & Screw System (Mar 20, 2006)
- K052368: Olecranonplate with Angular Stability (Oct 17, 2005)
- K051642: FR.O.H. Calcaneus Repair System (Aug 22, 2005)

Source page: https://510kreport.com/company/its-implantat-technologie-systeme