# K030881: Avanta Carpal Fusion Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Avanta Orthopaedics, Inc.
- Decided: Apr 10, 2003 after 21 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). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 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.
- K021321: Wrist Fusion Plate, Acu Med, Inc. (2002)

## Indications for use
The Avanta carpal fusion plate is designed for fusion of the carpal bones of the hand including; capitate, hamate, lunate, and triquetrum. The fusion plate is intended for use in patients suffering from pain and/or loss of function due to osteoarthritis, post-traumatic arthritis, fractures, revision of failed partial wrist fusions, carpal instability, or rheumatoid arthritis. The fusion plate is used in conjunction with screws that fix the plate to the carpal bones of the hand.

Source page: https://510kreport.com/device/K030881
Methodology: https://510kreport.com/methodology