# K141383: Acumed Hand Fracture System

- Pathway: 510(k) (Special)
- Applicant: Acumed, LLC
- Decided: Jun 13, 2014 after 17 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: 7 generations back to K962616 (1996). 30 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132769: Acumed Hand Plating System, Acumed, LLC (2014) Summary page 1.

## Most influential descendants
- K161894: SurgTech Trauma System (2017), 3 descendants of its own
- K242939: ARTFX Trauma Bone Plate and Screw System (2024), 2 descendants of its own
- K221150: Advanced Bone Plate (2023), 1 descendant of its own
- K261830: FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See Catalog);FRAXION Mini Plate System (Various - See Catalog);FRAXION Bone Screw System (Various - See Catalog) (2026), 0 descendants of its own
- K260277: Mikron Trauma Bone Plate& Screw System (2026), 0 descendants of its own

## Indications for use
The Acumed Hand Fracture System is intended for the management of fractures, fusions, and osteotomnies of the distal, middle and proximal phalanges and metacarpals and other bones of appropriate size far the devices

Source page: https://510kreport.com/device/K141383
Methodology: https://510kreport.com/methodology