# K102998: Congruent Bone Plate  System

- Pathway: 510(k) (Traditional)
- Applicant: Acumed, LLC
- Decided: Jan 4, 2011 after 88 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.
91 later devices descend from it; 10 cite it directly.
0 of 100 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 2.

## Most influential descendants
- K123241: Arthrex Fracture Plates (2013), 71 descendants of its own
- K141735: Arthrex Ankle Fusion Plating System (2014), 38 descendants of its own
- K141478: Arthrex Fracture Plates and Screws (2014), 23 descendants of its own
- K151732: Arthrex Fracture Plates (2015), 21 descendants of its own
- K170518: In2Bones Fracture and Correction System (2017), 15 descendants of its own

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

Source page: https://510kreport.com/device/K102998
Methodology: https://510kreport.com/methodology