# K071715: Acumed Congruent Bone Plate System

- Pathway: 510(k) (Special)
- Applicant: Acumed, LLC
- Decided: Jul 18, 2007 after 26 days
- Product code: HRS (Plate, Fixation, Bone)
- 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: 3 generations back to K000684 (2000). 8 ancestors in all.
34 later devices descend from it; 8 cite it directly.
0 of 43 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.

## Most influential descendants
- K080184: Distal Humeral Plates with Angular Stability (2008), 15 descendants of its own
- K113733: Small and Large Fragments Osteosynthesis System Neofix (2012), 11 descendants of its own
- K132945: CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral Nail (2014), 10 descendants of its own
- K142419: Mini and Micro Fragments Reconstruction System-NEOFIX (2014), 8 descendants of its own
- K182718: Mini and Micro Fragments Reconstruction System – GMReis (2019), 4 descendants of its own

## Indications for use
The Acumed Congruent Bone Plate System provides fixation for fractures, fusions, or osteotomies for the clavilce, humerus, radius, ulna, metacarpal, metatarsal, malleolus, tibia and fibula.

Source page: https://510kreport.com/device/K071715
Methodology: https://510kreport.com/methodology