# K113318: Acute Innovations Modular Ribloc System

- Pathway: 510(k) (Traditional)
- Applicant: Acute Innovations, LLC
- Decided: Jan 12, 2012 after 63 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K000684 (2000). 22 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073556: Medxpert P.E.S. (Pectus Exacvatum System), Medxpert Stratos, Medxpert GmbH (2008) Summary page 1.
- K051410: Acumed Rib Congrient Bone Plate System, Acumed, LLC (2005) Summary page 1.
- K101170: Acute Innovations Sternal Fixation System, Acute Innovations, LLC (2010)

## Most influential descendants
- K141241: Matrixrib Endo Thoracoscopic Rib Plating System (2014), 5 descendants of its own
- K183317: AdvantageRib System (2019), 4 descendants of its own
- K203474: Biomet Microfixation RibFix Advantage System (2021), 3 descendants of its own
- K221412: ARIX Rib System (2022), 1 descendant of its own
- K261892: ProRib Fixation System (2026), 0 descendants of its own

## Recalls of this device
- Oct 30, 2013 · Class II · Z-0852-2014: The ACUTE Innovations Ribloc U plus Rib Fracture Plating System is recalled because it has the potential to malfunction during installation in a surgery.

## Indications for use
The ACUTE Innovations® Modular RibLoc System is intended to stabilize and provide fixation for fractures, fusions, and osteotomies of the ribs, and for reconstructions of the chest wall and sternum.

Source page: https://510kreport.com/device/K113318
Methodology: https://510kreport.com/methodology