# Acute Innovations, LLC

- Location (FDA's records): Hillsboro, OR
- FDA decisions: 5 (2006–2012): 5 510(k) clearances
- Product codes: HRS (3), HWC (1), KTT (1)
- Predicates its devices cite: 12 (2 its own); citations of its devices by later devices: 6 (2 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Acu Med, Inc.: 2 (https://510kreport.com/company/acu-med)
- Synthes (Usa): 2 (https://510kreport.com/company/synthes-usa)
- Macropore Biosurgery, Inc.: 1 (https://510kreport.com/company/macropore-biosurgery)
- Medxpert GmbH: 1 (https://510kreport.com/company/medxpert)
- Acumed, LLC: 1 (https://510kreport.com/company/acumed)
- KLS-Martin L.P.: 1 (https://510kreport.com/company/kls-martin)
- Walter Lorenz Surgical, Inc.: 1 (https://510kreport.com/company/walter-lorenz-surgical)
- Inion, Ltd.: 1 (https://510kreport.com/company/inion)

## Firms that cite its devices most
- Medxpert GmbH: 1 (https://510kreport.com/company/medxpert)
- Synthes (USA) Products, LLC: 1 (https://510kreport.com/company/synthes-usa-products)
- Pioneer Surgical Technology: 1 (https://510kreport.com/company/pioneer-surgical-technology)
- Jeil Medical Corporation: 1 (https://510kreport.com/company/jeil-medical)

## Its most-cited devices
- K113318: Acute Innovations Modular Ribloc System (2012), cited by 2
- K101170: Acute Innovations Sternal Fixation System (2010), cited by 2
- K061206: Acute Bone Screw (2006), cited by 1
- K081588: RE-Zorb Plating System (2008), cited by 1

## Recent decisions
- K120163: Acute Innovations Biobridge Resorbable Plating System (Feb 17, 2012)
- K113318: Acute Innovations Modular Ribloc System (Jan 12, 2012)
- K101170: Acute Innovations Sternal Fixation System (Sep 17, 2010)
- K081588: RE-Zorb Plating System (Sep 3, 2008)
- K061206: Acute Bone Screw (Jun 19, 2006)

Source page: https://510kreport.com/company/acute-innovations
