# K132769: Acumed Hand Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Acumed, LLC
- Decided: Jan 6, 2014 after 124 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: 6 generations back to K962616 (1996). 29 ancestors in all.
7 later devices descend from it; 1 cites 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)
- K062498: Profyle System, Howmedica Osteonics Corp. (2006) Summary page 1.
- K051567: Aptus Titanium Osteosynthesis System, Medartis, Inc. (2005) Summary page 2.
- K102537: Aptus 1.5 Trilock, Medartis AG (2010) Summary page 2.
- K090522: Osteomed Hand Plate and Screw Fixation System, Osteomed LP (2009) Summary page 2.

## Most influential descendants
- K141383: Acumed Hand Fracture System (2014), 6 descendants of its own
- 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

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

Source page: https://510kreport.com/device/K132769
Methodology: https://510kreport.com/methodology