510(k) · Cleared
Recalled · Class II · 2016Prelude PF Patellae
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet, Inc. · KRR Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer
Cleared on Jan 30, 2015 as substantially equivalent to K123907 (Biomet Manufacturing Corp, 2013) and 1 other predicate after a 46-day review. Its family tree reaches back 4 generations to 2002. It has been recalled once.
- Decided
- Jan 30, 2015
- Review
- 46 days
- Class
- Class II
- Product code
- KRR
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 4 generations to K020841 (2002). 15 ancestors in all, the oldest K912245 (1991). No later device cites it as a predicate yet.
- Root · 4 generations backK020841 Avon Patellar ComponentHowmedica Osteonics Corp. · 2002
- 3 generations backK080029 Mako Surgical Corp. Patellofemoral Knee Implant SystemMako Surgical Corp. · 2008
- 2 generations backK082088 Mako Surgical Corp. Patellofemoral Knee Implant System IIMako Surgical Corp. · 2008
- 1 generation backK123907 Prelude PF Femoral Components (Mim Cocrmo), Prelude PF Femoral…Biomet Manufacturing Corp · 2013 · Recalled
- This deviceK143543 Prelude PF PatellaeBiomet, Inc. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K020841 | Avon Patellar Component | Howmedica Osteonics Corp. | 2002 | — |
| −3 | K080029 | Mako Surgical Corp. Patellofemoral Knee Implant System | Mako Surgical Corp. | 2008 | — |
| −2 | K082088 | Mako Surgical Corp. Patellofemoral Knee Implant System II | Mako Surgical Corp. | 2008 | — |
| −1 | K123907 | Prelude PF Femoral Components (Mim Cocrmo), Prelude PF Femoral Components… | Biomet Manufacturing Corp | 2013 | 1 |
| 0 (this device) | K143543 | Prelude PF Patellae | Biomet, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
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? (2)
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 |
|---|---|---|---|
| * | K123907 | Prelude PF Femoral Components (Mim Cocrmo), Prelude PF Femoral Components (Cast Cocrmo)…Summary page 4…, Semi-constrained, Cemented, metal/polymer (21 CFR §888.3540) Legally marketed devices to which substantial equivalence is claimed: x K123907 - Prelude PF Knee Resurfacing System x K040770 – Vanguard Patella Components Device Description The patella components are to… | 2013 |
| * | K040770 | Vanguard Patella ComponentsSummary page 4…Cemented, metal/polymer (21 CFR §888.3540) Legally marketed devices to which substantial equivalence is claimed: x K123907 - Prelude PF Knee Resurfacing System x K040770 – Vanguard Patella Components Device Description The patella components are to be used with the existing Prelude PF Knee Resurfa… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 9, 2016 | Class II | Z-1318-2016 | Device Design | Inadequate design control. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 4 companies; a new generation was cleared every 4.9 years on median.
- 7 of the 15 ancestors have a recall of any class.
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. 2015, 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 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143543 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143543: Prelude PF Patellae.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143543
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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