510(k) Report

510(k) · Cleared

Recalled · Class II · 2020

Regenerex Patella Components

K083782510(k) TraditionalCleared Apr 3, 2009105-day reviewClass II21 CFR 888.3565Recalls 2

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

Biomet Manufacturing Corp · MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer

Cleared on Apr 3, 2009 after a 105-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it. It has been recalled 2 times.

Decided
Apr 3, 2009
Review
105 days
Class
Class II
Product code
MBH
Recalls
2
Predicates
0

6 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2017: 1 descendant cleared2018: 1 descendant cleared2019: 1 descendant cleared2021: 2 descendants cleared2025: 1 descendant cleared20052010201520202025
  1. This deviceK083782 Regenerex Patella ComponentsBiomet Manufacturing Corp · 2009
  2. Descendant · cites it directly · 5 of its ownK171054 Biomet Knee Joint Replacement ProsthesesBiomet, Inc. · 2017 · Recalled
  3. Descendant · 2 generations on · 4 of its ownK181947 Persona Revision Knee SystemZimmer, Inc. · 2018 · Recalled
  4. Descendant · 3 generations on · 1 of its ownK191625 Persona Revision Knee SystemZimmer, Inc. · 2019 · Recalled
  5. Descendant · 3 generations on · 0 of its ownK243724 Persona® Revision Knee System (Persona Revision SoluTion™ Femoral…Zimmer, Inc. · 2025
  6. Descendant · 3 generations on · 0 of its ownK210829 Persona Revision Knee System Femoral Metaphyseal ConesZimmer, Inc. · 2021

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2017: 12018: 12019: 12021: 22025: 1
2017high 2 (2021) · low 0 (2020)2026

Most influential descendants

Showing 5 of 6 · See all
  • K171054Biomet Knee Joint Replacement ProsthesesBiomet, Inc. · 2017 · cites it directly5descendants
  • K181947Persona Revision Knee SystemZimmer, Inc. · 2018 · 2 generations on4descendants
  • K191625Persona Revision Knee SystemZimmer, Inc. · 2019 · 3 generations on1descendant
  • K243724Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components)Zimmer, Inc. · 2025 · 3 generations on0descendants
  • K210829Persona Revision Knee System Femoral Metaphyseal ConesZimmer, Inc. · 2021 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K083782Regenerex Patella ComponentsBiomet Manufacturing Corp2009—
+1K171054Biomet Knee Joint Replacement ProsthesesBiomet, Inc.20174
+2K181947Persona Revision Knee SystemZimmer, Inc.20181
+3K191625Persona Revision Knee SystemZimmer, Inc.20191
+3K243724Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components)Zimmer, Inc.2025—
+3K210829Persona Revision Knee System Femoral Metaphyseal ConesZimmer, Inc.2021—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201710
201810
201910
202120
202510
FIG. 1 — Lineage of K083782, 2009–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in MBH? 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 MBH device

  1. #1 K241597 Freedom® Total Knee System - Porous Tibial…score 19.9 · 8 generations · 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (6)

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

NumberDeviceApplicantDecidedDescendants
K171054Biomet Knee Joint Replacement ProsthesesBiomet, Inc.20175

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

Recalls of this device

DateClassRecallRoot causeReason
Apr 17, 2020Class IIZ-2146-2020Process controlPotential presence of elevated endotoxin levels that exceed the specification limit
Mar 22, 2017Class IIZ-2068-2017Under Investigation by firmpegs shearing post-operatively

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K171054 (Biomet, Inc., 2017) has gone furthest, with 5 descendants of its own.

How does its category compare?

All MBH devices

MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · MBH

8in 2025

2007: 102008: 32009: 32010: 42011: 52012: 52013: 62014: 92015: 82016: 42017: 42018: 62019: 12020: 72021: 62022: 72023: 62024: 102025: 82026 (partial year): 7
2007high 10 (2007) · low 1 (2019)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MBH

98in 2025

2007: 59 days median2008: 70 days median2009: 209 days median2010: 84 days median2011: 84 days median2012: 90 days median2013: 138 days median2014: 114 days median2015: 100 days median2016: 74 days median2017: 115 days median2018: 89 days median2020: 112 days median2021: 48 days median2022: 57 days median2023: 94 days median2024: 84 days median2025: 98 days median2026 (partial year): 153 days median
2007high 209 (2009) · low 48 (2021)2026

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

Recalls per year · MBH

1in 2024

2009: 22011: 152012: 1, 1 Class I2013: 4, 4 Class I2016: 12017: 92018: 12019: 12020: 22023: 22024: 12026 (partial year): 4
2007high 15 (2011) · low 0 (2007)2026

Class I (5 since 2007) Class II/III not classified

Adverse event reports per year · MBH

1,561in 2025

2007: 272008: 212009: 892010: 1212011: 2472012: 3702013: 3082014: 3852015: 9552016: 1,0342017: 1,0072018: 1,1912019: 1,3942020: 1,0892021: 1,5392022: 1,2612023: 1,2632024: 1,4972025: 1,561
2007high 1,561 (2025) · low 21 (2008)2025

MAUDE reports naming product code MBH, 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
20071059027
2008370021
20093209289
20104840121
201158415247
20125901 (1)370
201361384 (4)308
201491140385
201581000955
201647411,034
2017411591,007
201868911,191
20191—11,394
2020711221,089
202164801,539
202275701,261
202369421,263
2024108411,497
202589801,561
202671534—

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 MBH

The MBH category page

  • K261275Unity Total Knee System, Unity Knee Cementless CR FemurCorin, Ltd. · 2026
  • K261462LANDMARK Total Knee SystemSmith & Nephew, Inc. · 2026
  • K253728EVOLUTION® AM BIOFOAM® Tibial SystemMicroport Orthopedics, Inc. · 2026
  • K251840Zimmer® Persona® Personalized Knee SystemZimmer, Inc. · 2026
  • K253189Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)Zimmer, Inc. · 2026

https://510kreport.com/device/K083782 · printed Nov 6, 2026

Cite this page

510(k) Report. “K083782: Regenerex Patella Components.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083782

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026