# K123907: Prelude PF Femoral Components (Mim Cocrmo), Prelude PF Femoral Components (Cast Cocrmo), Prelude PF Patella Components,

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Manufacturing Corp
- Decided: Sep 3, 2013 after 258 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K020841 (2002). 14 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 16 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 1.
- K071413: Hemicap Patello-Femoral Resurfacing System, Arthrosurface, Inc. (2007) Summary page 1.
- K080029: Mako Surgical Corp. Patellofemoral Knee Implant System, Mako Surgical Corp. (2008) Summary page 1.
- K082088: Mako Surgical Corp. Patellofemoral Knee Implant System II, Mako Surgical Corp. (2008) Summary page 1.
- K040770: Vanguard Patella Components, Biomet Manufacturing, Inc. (2004) Summary page 1.
- K023546: Maxim Accel Knee System, Biomet, Inc. (2003) Summary page 1.

## Most influential descendants
- K143543: Prelude PF Patellae (2015), 0 descendants of its own

## Recalls of this device
- Mar 9, 2016 · Class II · Z-1318-2016: Inadequate design control.

## Indications for use
The Prelude™ PF Resurfacing Knee System is intended to be used in cemented patella-femoral arthroplasty in patients with degenerative arthritis in the distal femur and patella, patients with a history of patellar dislocation or patella fracture, or patients with failed previous surgery (arthroscopy, tibial tubercle elevation, lateral release) where pain, deformity or dysfunction persists.

Source page: https://510kreport.com/device/K123907
Methodology: https://510kreport.com/methodology