# K060127: Hemicap Patello-Femoral Resurfacing Prosthesis

- Pathway: 510(k) (Traditional)
- Applicant: Arthrosurface, Inc.
- Decided: Mar 16, 2006 after 57 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
No predicates in its family tree.
6 later devices descend from it; 4 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K071413: Hemicap Patello-Femoral Resurfacing System (2007), 3 descendants of its own
- K123907: Prelude PF Femoral Components (Mim Cocrmo), Prelude PF Femoral Components (Cast Cocrmo), Prelude PF Patella Components, (2013), 1 descendant of its own
- K231253: Overture Orthopaedics Patellofemoral System (2023), 0 descendants of its own
- K221048: Episealer Patellofemoral System (2022), 0 descendants of its own
- K181280: Patello-Femoral Wave (Kahuna) Arthroplasty System (2018), 0 descendants of its own

## Indications for use
The HemiCAPTM Patello-femoral Resurfacing Prosthesis is 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/K060127
Methodology: https://510kreport.com/methodology