510(k) Report

510(k) · Cleared

Recalled · Class II · 2016

Prelude PF Femoral Components (Mim Cocrmo), Prelude PF Femoral Components (Cast Cocrmo), Prelude PF Patella Components,

K123907510(k) TraditionalCleared Sep 3, 2013258-day reviewClass II21 CFR 888.3540Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Biomet Manufacturing Corp · KRR Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer

Cleared on Sep 3, 2013 as substantially equivalent to K060127 (Arthrosurface, Inc., 2006) and 5 other predicates after a 258-day review. Its family tree reaches back 3 generations to 2002. 1 later device descends from it. It has been recalled once.

Decided
Sep 3, 2013
Review
258 days
Class
Class II
Product code
KRR
Recalls
1
Predicates
6

Its longest line of descent runs back 3 generations to K020841 (2002). 14 ancestors in all, the oldest K912245 (1991). 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2007: 1 other ancestor2006: 1 other ancestor2004: 2 other ancestors2003: 1 other ancestor2005: 1 other ancestor2001: 1 other ancestor1995: 1 other ancestor1993: 1 other ancestor1992: 1 other ancestor1991: 1 other ancestor2015: 1 descendant clearedK020841 · Avon Patellar Component · Howmedica Osteonics Corp. · 2002K080029 · Mako Surgical Corp. Patellofemoral Knee Implant System · Mako Surgical Corp. · 2008K082088 · Mako Surgical Corp. Patellofemoral Knee Implant System II · Mako Surgical Corp. · 20081990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors2 generations back: 7 other ancestors 1 generation forward: 1 descendant K082088 · Mako Surgical Corp. Patellofemoral Knee Implant System II · Mako Surgical Corp. · 2008K080029 · Mako Surgical Corp. Patellofemoral Knee Implant System · Mako Surgical Corp. · 2008K020841 · Avon Patellar Component · Howmedica Osteonics Corp. · 20020
  1. Root · 3 generations backK020841 Avon Patellar ComponentHowmedica Osteonics Corp. · 2002
  2. 2 generations backK080029 Mako Surgical Corp. Patellofemoral Knee Implant SystemMako Surgical Corp. · 2008
  3. 1 generation backK082088 Mako Surgical Corp. Patellofemoral Knee Implant System IIMako Surgical Corp. · 2008
  4. This deviceK123907 Prelude PF Femoral Components (Mim Cocrmo), Prelude PF Femoral…Biomet Manufacturing Corp · 2013
  5. Descendant · cites it directly · 0 of its ownK143543 Prelude PF PatellaeBiomet, Inc. · 2015 · Recalled

Most influential descendants

Showing 1 of 1 · See all
  • K143543Prelude PF PatellaeBiomet, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K020841Avon Patellar ComponentHowmedica Osteonics Corp.2002—
−2K080029Mako Surgical Corp. Patellofemoral Knee Implant SystemMako Surgical Corp.2008—
−1K082088Mako Surgical Corp. Patellofemoral Knee Implant System IIMako Surgical Corp.2008—
0 (this device)K123907Prelude PF Femoral Components (Mim Cocrmo), Prelude PF Femoral Components…Biomet Manufacturing Corp2013—
+1K143543Prelude PF PatellaeBiomet, Inc.20151

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199110
199210
199310
199510
200110
200310
200420
200510
200610
200710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201510
FIG. 1 — Lineage of K123907, 2002–2015Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K231253 Overture Orthopaedics Patellofemoral Systemscore 5.6 · 1 generation · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (6)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K060127Hemicap Patello-Femoral Resurfacing Prosthesis
Summary page 1
…21CFR §888.3540 Pmoduct Code(s) KRR Legally marketed Arthrosurface Hemicap Patello-femoral Resurfacing System device(s) to which (K060127/K071413) equivalence is claimed Mako Patellofemoral Knee Implant System (K080029/K082088)…
Arthrosurface, Inc.2006—
*K071413Hemicap Patello-Femoral Resurfacing System
Summary page 1
…FR §888.3540 Pmoduct Code(s) KRR Legally marketed Arthrosurface Hemicap Patello-femoral Resurfacing System device(s) to which (K060127/K071413) equivalence is claimed Mako Patellofemoral Knee Implant System (K080029/K082088)…
Arthrosurface, Inc.2007—
*K080029Mako Surgical Corp. Patellofemoral Knee Implant System
Summary page 1
…oral Resurfacing System device(s) to which (K060127/K071413) equivalence is claimed Mako Patellofemoral Knee Implant System (K080029/K082088) Vanguard Patella Components (K040770)…
Mako Surgical Corp.2008—
*K082088Mako Surgical Corp. Patellofemoral Knee Implant System II
Summary page 1
…urfacing System device(s) to which (K060127/K071413) equivalence is claimed Mako Patellofemoral Knee Implant System (K080029/K082088) Vanguard Patella Components (K040770) Van…
Mako Surgical Corp.2008—
*K040770Vanguard Patella Components
Summary page 1
…Patellofemoral Knee Implant System (K080029/K082088) Vanguard Patella Components (K040770) Vanguard CR Femoral Component (K023546) Reason for 510(k) N…
Biomet Manufacturing, Inc.200413
*K023546Maxim Accel Knee System
Summary page 1
…Vanguard Patella Components (K040770) Vanguard CR Femoral Component (K023546) Reason for 510(k) New Device submission Device description The Prelude TM Patellofemoral (PF) Resurfacing K…
Biomet, Inc.200313

Also cleared against K060127: 3 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K143543Prelude PF PatellaeBiomet, Inc.20150

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Mar 9, 2016Class IIZ-1318-2016Device DesignInadequate design control.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 4.9 years on median.
  • 6 of the 14 ancestors have a recall of any class.
  • Of its descendants, K143543 (Biomet, Inc., 2015) has gone furthest, with 0 descendants of its own.
  • 3 other devices also cite its predicate K060127.

How does its category compare?

All KRR devices

KRR Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

FDA decisions per year · KRR

1in 2023

2007: 22008: 32012: 12013: 12015: 12016: 12018: 12020: 12021: 12022: 12023: 1
2007high 3 (2008) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KRR

116in 2008

2008: 116 days median
2007high 116 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KRR

3in 2022

2013: 12016: 12017: 22022: 3
2007high 3 (2022) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KRR

36in 2025

2009: 122010: 62011: 32012: 92013: 92014: 262015: 182016: 142017: 152018: 142019: 162020: 62021: 82022: 92023: 122024: 252025: 36
2007high 36 (2025) · low 0 (2007)2025

MAUDE reports naming product code KRR, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—00
2008311600
20090—012
20100—06
20110—03
20121—09
20131—19
20140—026
20151—018
20161—114
20170—215
20181—014
20190—016
20201—06
20211—08
20221—39
20231—012
20240—025
20250—036
20260—0—

What is it indicated for?

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.

Indications for use as stated in the FDA summary.

Also cleared against K060127

3 other devices cite the same predicate.

  • K231253Overture Orthopaedics Patellofemoral SystemOverture Resurfacing, Inc. · 2023
  • K221048Episealer Patellofemoral SystemEpisurf Medical, Inc. · 2022
  • K071413Hemicap Patello-Femoral Resurfacing SystemArthrosurface, Inc. · 2007

More from Biomet Manufacturing Corp

201 FDA decisions under this applicant name. See the company

  • P010014/S119Cementless Oxford Partial Knee SystemBiomet Manufacturing Corp · 2026
  • P010014/S118Oxford Partial Knee Anatomic Vivacit-E Meniscal BearingsBiomet Manufacturing Corp · 2026
  • P010014/S117Oxford™ Partial Knee SystemBiomet Manufacturing Corp · 2026
  • P010014/S112Oxford Partial Knee System; Cementless Oxford™Partial Knee SystemBiomet Manufacturing Corp · 2026
  • P010014/S116Oxford® Partial Knee SystemBiomet Manufacturing Corp · 2026

Recent decisions in KRR

The KRR category page

  • K231253Overture Orthopaedics Patellofemoral SystemOverture Resurfacing, Inc. · 2023
  • K221048Episealer Patellofemoral SystemEpisurf Medical, Inc. · 2022
  • K211303Avon Patello-femoral Joint ProsthesisHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2021
  • K200122MOTO PFJ SystemMedacta International S.A. · 2020
  • K181280Patello-Femoral Wave (Kahuna) Arthroplasty SystemArthrosurface, Inc. · 20183 recalls

https://510kreport.com/device/K123907 · printed Nov 5, 2026

Cite this page

510(k) Report. “K123907: Prelude PF Femoral Components (Mim Cocrmo), Prelude PF Femoral Components (Cast Cocrmo), Prelude PF Patella Components,.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K123907

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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