# K101170: Acute Innovations Sternal Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Acute Innovations, LLC
- Decided: Sep 17, 2010 after 144 days
- Product code: KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K011076 (2001). 5 ancestors in all.
10 later devices descend from it; 2 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K931246: Cerclage Wire Crimp Sleeve, Acu Med, Inc. (1994) Summary page 2.
- K032413: KLS-Martin Sternal Plating System, KLS-Martin L.P. (2003) Summary page 2.
- K011076: Lorenz Sternal Closure System with Modular Screw, Walter Lorenz Surgical, Inc. (2001)
- K052683: Synthes (Usa) Sternal Fixation System, Synthes (Usa) (2005) Summary page 2.
- K031508: Synthes (Usa) Sternal Reconstruction System, Synthes (Usa) (2003) Summary page 2.

## Most influential descendants
- K113318: Acute Innovations Modular Ribloc System (2012), 8 descendants of its own
- 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

## Indications for use
The ACUTE Innovations® Sternal Fixation System is intended for use in the stabilization and fixation of fractures of the anterior chest wall, including sternal fixation following sternotomy and sternal reconstructive surgical procedures.

Source page: https://510kreport.com/device/K101170
Methodology: https://510kreport.com/methodology