# K051410: Acumed Rib Congrient Bone Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Acumed, LLC
- Decided: Jul 21, 2005 after 51 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: 3 generations back to K000684 (2000). 11 ancestors in all.
9 later devices descend from it; 1 cites it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012655: Congruent Bone Plate System, Acu Med, Inc. (2001) Summary page 1.
- K032413: KLS-Martin Sternal Plating System, KLS-Martin L.P. (2003) Summary page 1.
- K024169: Macropore OS Reconstruction, Macropore Biosurgery, Inc. (2003) Summary page 1.

## 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

## Recalls of this device
- Feb 28, 2011 · Not classified · Z-0336-2012: RibLoc screw from lot L1008007 was out of specification. It would not engage with the hex tip properly.

## Indications for use
The Acumed Rib Congruent Bone Plate System provides fixation during fractures, fusions, and osteotomies for the rib.

Source page: https://510kreport.com/device/K051410
Methodology: https://510kreport.com/methodology