# K181280: Patello-Femoral Wave (Kahuna) Arthroplasty System

- Pathway: 510(k) (Special)
- Applicant: Arthrosurface, Inc.
- Decided: Jun 14, 2018 after 30 days
- Product code: KRR (Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3540
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K060127 (2006). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071413: Hemicap Patello-Femoral Resurfacing System, Arthrosurface, Inc. (2007) Summary page 5.

## Recalls of this device
- Dec 22, 2022 · Class II · Z-1045-2023: The recall is due to observed intra-operative screw failure. When pre-drilled with 1.3mm drill bit for 2.0mm screws and 1.6mm drill bit for 2.4mm we have observed screw failure due to excessive torque
- Dec 22, 2022 · Class II · Z-1046-2023: The recall is due to observed intra-operative screw failure. When pre-drilled with 1.3mm drill bit for 2.0mm screws and 1.6mm drill bit for 2.4mm we have observed screw failure due to excessive torque
- Dec 22, 2022 · Class II · Z-1047-2023: The recall is due to observed intra-operative screw failure. When pre-drilled with 1.3mm drill bit for 2.0mm screws and 1.6mm drill bit for 2.4mm we have observed screw failure due to excessive torque

## Indications for use
Intended to be used in cemented arthroplasty in patients with osteoarthritis limited to the distal patello-femoral joint, patients with a history of patellar dislocation or patellar fracture, and those patients with failed previous surgery (arthroscopy, tibial tubercle elevation, lateral release, etc.) where pain, deformity or dysfunction persists.

Source page: https://510kreport.com/device/K181280
Methodology: https://510kreport.com/methodology