# K991873: Kmi Wrist Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Kinetikos Medical, Inc.
- Decided: Aug 17, 1999 after 76 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: 2 generations back to K915818 (1992). 3 ancestors in all.
117 later devices descend from it; 7 cite it directly.
0 of 121 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990094: Kmi Wrist Fusion System, Kinetikos Medical, Inc. (1999) Summary page 1.
- K800806: I.C.S. Mini & Small Fragment Set, Howmedica Corp. (1980) Summary page 1.

## Most influential descendants
- K021321: Wrist Fusion Plate (2002), 113 descendants of its own
- 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

## Indications for use
The KMI Wrist Fusion System is comprised of the fotal wrist fusion plate which is intended for wrist arthrodesis, providing fixation of small bones such as the radius and carpal bones and indicated for use in patients suffering pain and/or loss of function due to osteoarthritis, post-traumatic arthritis, fractures, revision of failed wrist fusions, segmental bone loss, or theumatoid arthritis, and the KMI limited wrist fusion plate is intended for use in patients suffering pain and/or loss of function due to osteoarthritis, post-traumatic arthritis, fractures, revision of failed partial wrist fusions, carpal instability, or rheumatoid arthritis.

Source page: https://510kreport.com/device/K991873
Methodology: https://510kreport.com/methodology