510(k) · Cleared
ClearedEpisealer Patellofemoral System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Episurf Medical, Inc. · KRR Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer
Cleared on Dec 23, 2022 as substantially equivalent to K060127 (Arthrosurface, Inc., 2006) after a 259-day review. Its family tree reaches back 1 generation to 2006.
- Decided
- Dec 23, 2022
- Review
- 259 days
- Class
- Class II
- Product code
- KRR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K060127 (2006). No later device cites it as a predicate yet.
- Root · 1 generation backK060127 Hemicap Patello-Femoral Resurfacing ProsthesisArthrosurface, Inc. · 2006
- This deviceK221048 Episealer Patellofemoral SystemEpisurf Medical, Inc. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K060127 | Hemicap Patello-Femoral Resurfacing Prosthesis | Arthrosurface, Inc. | 2006 | — |
| 0 (this device) | K221048 | Episealer Patellofemoral System | Episurf Medical, Inc. | 2022 | — |
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 |
|---|---|---|---|
| * | K060127 | Hemicap Patello-Femoral Resurfacing ProsthesisSummary page 4…emented Prosthesis Class: II Product Code: KRR Primary Predicate: Arthrosurface Patello-Femoral Arthroplasty System (K060127) Reference Devices: Arthrosurface Patello-Femoral Arthroplasty System (K181280, K071413… | 2006 |
| † | K181280 | Patello-Femoral Wave (Kahuna) Arthroplasty System | 2018 |
| † | K071413 | Hemicap Patello-Femoral Resurfacing System | 2007 |
| † | K172326 | Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 3 other devices also cite its predicate K060127.
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. 2022, 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?
The Episealer Patellofemoral System is intended to be used in patients with osteoarthritis limited to the distal patellofemoral 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.
The device is intended for cemented fixation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221048 · printed Nov 5, 2026
Cite this page
510(k) Report. “K221048: Episealer Patellofemoral System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K221048
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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