# K143543: Prelude PF Patellae

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Jan 30, 2015 after 46 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: 4 generations back to K020841 (2002). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123907: Prelude PF Femoral Components (Mim Cocrmo), Prelude PF Femoral Components (Cast Cocrmo), Prelude PF Patella Components,, Biomet Manufacturing Corp (2013) Summary page 4.
- K040770: Vanguard Patella Components, Biomet Manufacturing, Inc. (2004) Summary page 4.

## 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 patellofemoral 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/K143543
Methodology: https://510kreport.com/methodology