# K131380: Acumed Totalw Rist Fusion Plating System

- Pathway: 510(k) (Special)
- Applicant: Acumed, LLC
- Decided: Jun 10, 2013 after 27 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: 4 generations back to K915818 (1992). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100123: Acumed Wrist Arthrodesis Plate System, Acumed, LLC (2010) Summary page 2.
- K042355: Synthes (Usa) LCP Wrist Fusion Plates, Synthes (Usa) (2004) Summary page 2.
- K023879: Small Titanium Wrist Fusion Plate, Synthes (Usa) (2003). Our OCR of the scanned summary read K023870, FDA’s number for Flexima Biliary Catheter (Boston Scientific/Medi-Tech). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Synthes Small Titanium Wrist Fusion Plate”.
- K011458: Synthes Straight Wrist Fusion Plate, 170MM, Synthes (Usa) (2001) Summary page 2.
- K000558: Synthes (Usa) Wrist Fusion Plates (WFP), Synthes (Usa) (2000)
- K052754: Wrist Fusion Plate, Dvo Extremity Solutions, LLC (2005) Summary page 2.
- K991873: Kmi Wrist Fusion System, Kinetikos Medical, Inc. (1999) Summary page 2.

## Indications for use
The Acumed Wrist Arthrodesis Plate System is intended for wrist arthrodesis and fractures of other small bones. Specific indications include post traumatic arthritis of the joints of the wrist, rheumatoid wrist deformities requiring restoration, complex carpal instability, post-septic arthritis of the wrist, severe unremitting wrist pain related to motion, brachial plexus nerve palsies, tumor resection, and spastic deformities.

Source page: https://510kreport.com/device/K131380
Methodology: https://510kreport.com/methodology