# K990094: Kmi Wrist Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Kinetikos Medical, Inc.
- Decided: Feb 18, 1999 after 37 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: 1 generation back to K915818 (1992). 1 ancestor in all.
127 later devices descend from it; 3 cite it directly.
0 of 129 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K915818: Synthes (R) Titanium Small Reconstruction Plate, Synthes (Usa) (1992) Summary page 1.
- (no number) Synthes 3.5 mm Dynamic Compression Plate: named in the summary without a submission number

## Most influential descendants
- K991873: Kmi Wrist Fusion System (1999), 117 descendants of its own
- 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

## Indications for use
The KMI Wrist Fusion System is 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 rtheumatoid arthritis.

Source page: https://510kreport.com/device/K990094
Methodology: https://510kreport.com/methodology