# K221048: Episealer Patellofemoral System

- Pathway: 510(k) (Traditional)
- Applicant: Episurf Medical, Inc.
- Decided: Dec 23, 2022 after 259 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K060127 (2006). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060127: Hemicap Patello-Femoral Resurfacing Prosthesis, Arthrosurface, Inc. (2006) Summary page 4.

## Indications for use
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.

Source page: https://510kreport.com/device/K221048
Methodology: https://510kreport.com/methodology