510(k) Report

510(k) · Cleared

Cleared

E1 Series a Patellae, Standard 3-Peg, E1 Series a Patellae, Thin 3-Peg, E1 Series Patellae, Asymmetrical, 3-Peg

K140902510(k) TraditionalCleared Jul 3, 201485-day reviewClass II21 CFR 888.3560

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

Biomet, Inc. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Cleared on Jul 3, 2014 as substantially equivalent to K110362 (Biomet Manufacturing Corp, 2011) and 1 other predicate after an 85-day review. Its family tree reaches back 3 generations to 1991. 6 later devices descend from it.

Decided
Jul 3, 2014
Review
85 days
Class
Class II
Product code
JWH
Recalls
None
Predicates
2

Its longest line of descent runs back 3 generations to K912245 (1991). 5 ancestors in all. 6 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2005: 1 other ancestor1993: 1 other ancestor2017: 1 descendant cleared2018: 1 descendant cleared2019: 1 descendant cleared2021: 2 descendants cleared2025: 1 descendant clearedReference device: K080528 · E-Poly Tibial Bearings · Biomet Orthopedics, Inc. · 2008K912245 · Agc Revision Knee Prothesis · Biomet, Inc. · 1991 · recalledK040770 · Vanguard Patella Components · Biomet Manufacturing, Inc. · 2004 · recalledK110362 · Vanguard Asymmetrical Patellar Component · Biomet Manufacturing Corp · 20111990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 2 other ancestors 1 generation forward: 1 descendant2 generations forward: 1 descendant3 generations forward: 3 descendants4 generations forward: 1 descendant K110362 · Vanguard Asymmetrical Patellar Component · Biomet Manufacturing Corp · 2011K040770 · Vanguard Patella Components · Biomet Manufacturing, Inc. · 2004 · recalledK912245 · Agc Revision Knee Prothesis · Biomet, Inc. · 1991 · recalled0
  1. Root · 3 generations backK912245 Agc Revision Knee ProthesisBiomet, Inc. · 1991 · Recalled
  2. 2 generations backK040770 Vanguard Patella ComponentsBiomet Manufacturing, Inc. · 2004 · Recalled
  3. 1 generation backK110362 Vanguard Asymmetrical Patellar ComponentBiomet Manufacturing Corp · 2011
  4. This deviceK140902 E1 Series a Patellae, Standard 3-Peg, E1 Series a Patellae, Thin…Biomet, Inc. · 2014
  5. Descendant · cites it directly · 5 of its ownK171054 Biomet Knee Joint Replacement ProsthesesBiomet, Inc. · 2017 · Recalled
  6. Descendant · 2 generations on · 4 of its ownK181947 Persona Revision Knee SystemZimmer, Inc. · 2018 · Recalled
  7. Descendant · 3 generations on · 1 of its ownK191625 Persona Revision Knee SystemZimmer, Inc. · 2019 · Recalled
  8. Descendant · 3 generations on · 0 of its ownK243724 Persona® Revision Knee System (Persona Revision SoluTion™ Femoral…Zimmer, Inc. · 2025
  9. 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
−3K912245Agc Revision Knee ProthesisBiomet, Inc.19913
−2K040770Vanguard Patella ComponentsBiomet Manufacturing, Inc.200413
−1K110362Vanguard Asymmetrical Patellar ComponentBiomet Manufacturing Corp2011—
0 (this device)K140902E1 Series a Patellae, Standard 3-Peg, E1 Series a Patellae, Thin 3-Peg, E1…Biomet, Inc.2014—
+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—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199310
200510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201710
201810
201910
202120
202510
FIG. 1 — Lineage of K140902, 1991–2025Source: 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), 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 JWH? 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 JWH device

  1. #1 K221479 Persona Personalized Knee Systemscore 22.4 · 11 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K110362Vanguard Asymmetrical Patellar Component
Summary page 1
…888.3560) Legally marketed devices to which substantial equivalence is claimed: * Vanguard Asymmetrical Patellar Component (K110362) * Vanguard Patella Components (K040770) * E-Poly (aka El) Tibial Bearings (K080528) - reference for material and m…
Biomet Manufacturing Corp2011—
*K040770Vanguard Patella Components
Summary page 1
…Legally marketed devices to which substantial equivalence is claimed: * Vanguard Asymmetrical Patellar Component (K110362) * Vanguard Patella Components (K040770) * E-Poly (aka El) Tibial Bearings (K080528) - reference for material and manufacturing process Device De…
Biomet Manufacturing, Inc.200413
†K080528E-Poly Tibial BearingsBiomet Orthopedics, Inc.2008—

Also cleared against K110362: 1 other device →

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)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 23 years and passes through 3 companies; a new generation was cleared every 6.9 years on median.
  • 4 of the 5 ancestors have a recall of any class.
  • Of its descendants, K171054 (Biomet, Inc., 2017) has gone furthest, with 5 descendants of its own.
  • 1 other device also cites its predicate K110362.

How does its category compare?

All JWH devices

JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.

FDA decisions per year · JWH

20in 2025

2007: 182008: 172009: 112010: 192011: 252012: 332013: 312014: 332015: 272016: 182017: 252018: 252019: 282020: 222021: 242022: 172023: 202024: 192025: 202026 (partial year): 12
2007high 33 (2012) · low 11 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JWH

55in 2025

2007: 74 days median2008: 81 days median2009: 168 days median2010: 85 days median2011: 87 days median2012: 85 days median2013: 128 days median2014: 98 days median2015: 87 days median2016: 88 days median2017: 118 days median2018: 90 days median2019: 133 days median2020: 59 days median2021: 61 days median2022: 56 days median2023: 57 days median2024: 89 days median2025: 55 days median2026 (partial year): 63 days median
2007high 168 (2009) · low 55 (2025)2026

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

Recalls per year · JWH

2in 2025

2007: 142008: 102009: 1092010: 322011: 272012: 852013: 312014: 132015: 112016: 172017: 612018: 142019: 52020: 22021: 82022: 122023: 672024: 72025: 22026 (partial year): 4
2007high 109 (2009) · low 2 (2020)2026

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

Adverse event reports per year · JWH

9,306in 2025

2007: 1,3052008: 1,4832009: 1,8702010: 3,2862011: 5,1332012: 5,2032013: 6,1352014: 6,7222015: 6,8812016: 7,5862017: 12,2632018: 14,0712019: 14,9872020: 12,5922021: 9,4082022: 8,3642023: 8,9472024: 10,8282025: 9,306
2007high 14,987 (2019) · low 1,305 (2007)2025

MAUDE reports naming product code JWH, 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
20071874141,305
20081781101,483
2009111681091,870
20101985323,286
20112587275,133
20123385855,203
201331128316,135
20143398136,722
20152787116,881
20161888177,586
2017251186112,263
201825901414,071
201928133514,987
20202259212,592
2021246189,408
20221756128,364
20232057678,947
20241989710,828
2025205529,306
202612634—

What is it indicated for?

1. Painful and disabled knee joint resulting from osteoarthritls, rheumatoid arthritis, and/or traumatic arthritis where one or more compartments are involved.

2. Correction of varus, valgus, or posttraumatic deformity.

3. Correction or revision of unsuccessful osteotomy, arthrodesls, or failure of previous joint replacement procedure.

Tibial bearings are indicated for use with both cemented and uncemented Biomet tibial trays.

All-polyethylene patellar components are indicated for cemented use only.

Indications for use as stated in the FDA summary.

Also cleared against K110362

1 other device cites the same predicate.

  • K171054Biomet Knee Joint Replacement ProsthesesBiomet, Inc. · 20174 recalls

More from Biomet, Inc.

449 FDA decisions under this applicant name. See the company

  • K253434OSSTM Orthopedic Salvage SystemBiomet, Inc. · 2026
  • K251270Taperloc® Complete Hip StemBiomet, Inc. · 2026
  • K241014Biomet Kirschner Wires (K-Wires)Biomet, Inc. · 2024
  • K222760StageOne™ Select Hip Cement Spacer MoldsBiomet, Inc. · 2022
  • K221968StageOne™ Shoulder Cement Spacer MoldsBiomet, Inc. · 2022

Recent decisions in JWH

The JWH category page

  • K262057GMK ExtensionMedacta International SA · 2026
  • K260063GSPE SpacerThe General Hospital Corporation, d/b/a Massachusetts · 2026
  • K262293EVOLUTION MPX™ Total Knee SystemSuzhou Microport Orthorecon Co., Ltd. · 2026
  • K262341b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem…B-One Ortho, Corp. · 2026
  • K262130ATTUNE Revision Knee SystemDepuy Orthopaedics, Inc. · 2026

https://510kreport.com/device/K140902 · printed Nov 6, 2026

Cite this page

510(k) Report. “K140902: E1 Series a Patellae, Standard 3-Peg, E1 Series a Patellae, Thin 3-Peg, E1 Series Patellae, Asymmetrical, 3-Peg.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140902

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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