# K021321: Wrist Fusion Plate

- Pathway: 510(k) (Traditional)
- Applicant: Acu Med, Inc.
- Decided: Jul 17, 2002 after 83 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 K915818 (1992). 12 ancestors in all.
113 later devices descend from it; 3 cite it directly.
0 of 126 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991873: Kmi Wrist Fusion System, Kinetikos Medical, Inc. (1999) Summary page 1.
- K012655: Congruent Bone Plate System, Acu Med, Inc. (2001) Summary page 1.

## Most influential descendants
- K050681: Omnitech System & Easy Lock Osteosystem with Xtremities Plates (2005), 92 descendants of its own
- K092670: Biodrive Micro Screw System (2009), 68 descendants of its own
- K111678: Ortho Solutions Extremity Fixation Implants for Osteosysnthesis (2012), 58 descendants of its own
- K141784: Ortho Solutions Ultos Plating System (2014), 28 descendants of its own
- K131722: I.T.S. Extremity Fixation Systems (2013), 24 descendants of its own

## Indications for use
The Wrist Fusion Plate and accessories are designed specifically for fusion of the small bones of the hand inchding: hamate, capitate, lunate, triqueteral.

Source page: https://510kreport.com/device/K021321
Methodology: https://510kreport.com/methodology