# K093163: Integra Total Wrist Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Integra LifeSciences Corporation
- Decided: Dec 15, 2009 after 70 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). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000558: Synthes (Usa) Wrist Fusion Plates (WFP), Synthes (Usa) (2000) Summary page 2.
- K042355: Synthes (Usa) LCP Wrist Fusion Plates, Synthes (Usa) (2004) Summary page 2.
- K991873: Kmi Wrist Fusion System, Kinetikos Medical, Inc. (1999) Summary page 2.

## Indications for use
The INTEGRA Total Wrist Fusion System is indicated for use in patients with: * Posttraumatic 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 * Spastic deformation * Pain and/or loss of function due to osteoarthritis * Revision of failed partial wrist fusions

Source page: https://510kreport.com/device/K093163
Methodology: https://510kreport.com/methodology