510(k) · Cleared
Recalled · Class II · 2022Patello-Femoral Wave (Kahuna) Arthroplasty System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrosurface, Inc. · KRR Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer
Cleared on Jun 14, 2018 as substantially equivalent to K071413 (Arthrosurface, Inc., 2007) after a 30-day review. Its family tree reaches back 2 generations to 2006. It has been recalled 3 times.
- Decided
- Jun 14, 2018
- Review
- 30 days
- Class
- Class II
- Product code
- KRR
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 2 generations to K060127 (2006). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KRR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KRR device
- #1 K231253 Overture Orthopaedics Patellofemoral Systemscore 5.6 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K071413 | Hemicap Patello-Femoral Resurfacing SystemSummary page 5…ns and design principles to the following predicate devices, which have been previously cleared by the FDA: HemiCAP Patello-Femoral Resurfacing Prosthesis K071413 The fundamental scientific technology of the proposed device has not changed relative to the predicate devices. x Has the same I… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 22, 2022 | Class II | Z-1045-2023 | Device Design | 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 | Device Design | 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 | Device Design | 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. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 1 company; a new generation was cleared every 10.6 years on median.
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K071413.
How does its category compare?
All KRR devicesKRR Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · KRR
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · KRR
116in 2008
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KRR
3in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KRR
36in 2025
MAUDE reports naming product code KRR, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 0 |
| 2008 | 3 | 116 | 0 | 0 |
| 2009 | 0 | — | 0 | 12 |
| 2010 | 0 | — | 0 | 6 |
| 2011 | 0 | — | 0 | 3 |
| 2012 | 1 | — | 0 | 9 |
| 2013 | 1 | — | 1 | 9 |
| 2014 | 0 | — | 0 | 26 |
| 2015 | 1 | — | 0 | 18 |
| 2016 | 1 | — | 1 | 14 |
| 2017 | 0 | — | 2 | 15 |
| 2018 | 1 | — | 0 | 14 |
| 2019 | 0 | — | 0 | 16 |
| 2020 | 1 | — | 0 | 6 |
| 2021 | 1 | — | 0 | 8 |
| 2022 | 1 | — | 3 | 9 |
| 2023 | 1 | — | 0 | 12 |
| 2024 | 0 | — | 0 | 25 |
| 2025 | 0 | — | 0 | 36 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K181280 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181280: Patello-Femoral Wave (Kahuna) Arthroplasty System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181280
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026