510(k) · Cleared

Recalled · Class II · 2020

Vanguard Patella Components

K040770510(k) SpecialCleared Apr 22, 200428-day reviewClass II21 CFR 888.3560Recalls 13

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

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

Cleared on Apr 22, 2004 as substantially equivalent to K912245 (Biomet, Inc., 1991) and 1 other predicate after a 28-day review. Its family tree reaches back 1 generation to 1991. 54 later devices descend from it. It has been recalled 13 times.

Decided: Apr 22, 2004
Review: 28 days
Class: Class II
Product code: JWH
Recalls: 13
Predicates: 2

Its longest line of descent runs back 1 generation to K912245 (1991). 2 ancestors in all. 54 later devices descend from it, 8 citing it directly.

By dateBy generation

Root · 1 generation backK912245 Agc Revision Knee ProthesisBiomet, Inc. · 1991 · Recalled
This deviceK040770 Vanguard Patella ComponentsBiomet Manufacturing, Inc. · 2004
Descendant · cites it directly · 47 of its ownK061340 23 MM Single-Peg Patella ComponentBiomet Manufacturing, Inc. · 2006
Descendant · 2 generations on · 46 of its ownK113550 Vanguard Complete Knee SystemBiomet Manufacturing Corp · 2012 · Recalled
Descendant · 3 generations on · 8 of its ownK221479 Persona Personalized Knee SystemZimmer, Inc. · 2022
Descendant · 3 generations on · 8 of its ownK151266 Physica CR Knee SystemLima Corporate S.P.A. · 2015
Descendant · 3 generations on · 7 of its ownK152008 Physica PS Knee SystemLima Corporate S.P.A. · 2015

Showing 5 of 54 descendants. See all descendants

Descendants cleared per year

2006high 7 (2024) · low 0 (2007)2026

Most influential descendants

Showing 5 of 54 · See all

K06134023 MM Single-Peg Patella ComponentBiomet Manufacturing, Inc. · 2006 · cites it directly47descendants
K113550Vanguard Complete Knee SystemBiomet Manufacturing Corp · 2012 · 2 generations on46descendants
K221479Persona Personalized Knee SystemZimmer, Inc. · 2022 · 3 generations on8descendants
K151266Physica CR Knee SystemLima Corporate S.P.A. · 2015 · 3 generations on8descendants
K152008Physica PS Knee SystemLima Corporate S.P.A. · 2015 · 3 generations on7descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K912245	Agc Revision Knee Prothesis	Biomet, Inc.	1991	3
0 (this device)	K040770	Vanguard Patella Components	Biomet Manufacturing, Inc.	2004	—
+1	K061340	23 MM Single-Peg Patella Component	Biomet Manufacturing, Inc.	2006	—
+2	K113550	Vanguard Complete Knee System	Biomet Manufacturing Corp	2012	7
+3	K221479	Persona Personalized Knee System	Zimmer, Inc.	2022	—
+3	K151266	Physica CR Knee System	Lima Corporate S.P.A.	2015	—
+3	K152008	Physica PS Knee System	Lima Corporate S.P.A.	2015	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1993	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	2	0
2011	1	0
2012	1	0
2013	5	0
2014	3	0
2015	4	0
2016	2	0
2017	1	0
2018	3	0
2019	4	0
2020	2	0
2021	5	0
2022	2	0
2023	2	0
2024	7	0
2025	4	0
2026	6	0

FIG. 1 — Lineage of K040770, 1991–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 K221479 Persona Personalized Knee Systemscore 22.4 · 11 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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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	Applicant	Decided	Recalls
*	K912245	Agc Revision Knee Prothesis Summary page 1 …patellofemorotibial, cemented, polymer/metal/ polymer, semi-constrained Legally Marketed Devices To Which Substantial Equivalence Is Claimed: AGC® LP Patellar Button - K912245 and K921182 Device Description: Features of the Vanguard TM Patella Components are as follows: * 1", true dome shape :…	Biomet, Inc.	1991	3
*	K921182	Ultra High Molecular Weight Polyethylene Component Summary page 1 …rotibial, cemented, polymer/metal/ polymer, semi-constrained Legally Marketed Devices To Which Substantial Equivalence Is Claimed: AGC® LP Patellar Button - K912245 and K921182 Device Description: Features of the Vanguard TM Patella Components are as follows: * 1", true dome shape : Grooves on…	Biomet, Inc.	1993	3

Also cleared against K912245: 6 other devices →

What descends from it? (54)

See all 54

8 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K061340	23 MM Single-Peg Patella Component	Biomet Manufacturing, Inc.	2006	47
K110362	Vanguard Asymmetrical Patellar Component	Biomet Manufacturing Corp	2011	7
K140902	E1 Series a Patellae, Standard 3-Peg, E1 Series a Patellae, Thin 3-Peg, E1 Series…	Biomet, Inc.	2014	6
K171054	Biomet Knee Joint Replacement Prostheses	Biomet, Inc.	2017	5
K123907	Prelude PF Femoral Components (Mim Cocrmo), Prelude PF Femoral Components (Cast Cocrmo)…	Biomet Manufacturing Corp	2013	1
K143543	Prelude PF Patellae	Biomet, Inc.	2015	0
K123692	Pipeline Knee System	Pipeline Orthopedics	2013	0
K061433	Vanguard Anatomic Patella Groove (Apg) / Vanguard V Groove	Biomet Manufacturing, Inc.	2006	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Apr 17, 2020	Class II	Z-2154-2020	Process control	Potential presence of elevated endotoxin levels that exceed the specification limit
Dec 21, 2018	Class II	Z-0937-2019	Under Investigation by firm	Vanguard Knee System Series-A Standard Patella a potential commingle that could result in the size of the implant not matching the size on the label.
Feb 17, 2017	Class II	Z-1861-2017	Process design	Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.
Oct 4, 2011	Not classified	Z-0697-2012	Error in labeling	Correcting language on product labeling which incorrectly states patella buttons are intended for use with the AGC knee system.
Oct 4, 2011	Not classified	Z-0695-2012	Error in labeling	Correcting language on product labeling which incorrectly states patella buttons are intended for use with the AGC knee system.
Oct 4, 2011	Not classified	Z-0699-2012	Error in labeling	Correcting language on product labeling which incorrectly states patella buttons are intended for use with the AGC knee system.
Oct 4, 2011	Not classified	Z-0701-2012	Error in labeling	Correcting language on product labeling which incorrectly states patella buttons are intended for use with the AGC knee system.
Oct 4, 2011	Not classified	Z-0702-2012	Error in labeling	Correcting language on product labeling which incorrectly states patella buttons are intended for use with the AGC knee system.
Oct 4, 2011	Not classified	Z-0704-2012	Error in labeling	Correcting language on product labeling which incorrectly states patella buttons are intended for use with the AGC knee system.
Oct 4, 2011	Not classified	Z-0696-2012	Error in labeling	Correcting language on product labeling which incorrectly states patella buttons are intended for use with the AGC knee system.
Oct 4, 2011	Not classified	Z-0698-2012	Error in labeling	Correcting language on product labeling which incorrectly states patella buttons are intended for use with the AGC knee system.
Oct 4, 2011	Not classified	Z-0700-2012	Error in labeling	Correcting language on product labeling which incorrectly states patella buttons are intended for use with the AGC knee system.
Oct 4, 2011	Not classified	Z-0703-2012	Error in labeling	Correcting language on product labeling which incorrectly states patella buttons are intended for use with the AGC knee system.

The 5 latest of 13 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

2 of the 2 ancestors have a recall of any class.
Of its descendants, K061340 (Biomet Manufacturing, Inc., 2006) has gone furthest, with 47 descendants of its own.
6 other devices also cite its predicate K912245.

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.

FDA decisions per year · JWH

20in 2025

2007high 33 (2012) · low 11 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JWH

55in 2025

2007high 168 (2009) · low 55 (2025)2026

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

Recalls per year · JWH

2in 2025

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	18	74	14	1,305
2008	17	81	10	1,483
2009	11	168	109	1,870
2010	19	85	32	3,286
2011	25	87	27	5,133
2012	33	85	85	5,203
2013	31	128	31	6,135
2014	33	98	13	6,722
2015	27	87	11	6,881
2016	18	88	17	7,586
2017	25	118	61	12,263
2018	25	90	14	14,071
2019	28	133	5	14,987
2020	22	59	2	12,592
2021	24	61	8	9,408
2022	17	56	12	8,364
2023	20	57	67	8,947
2024	19	89	7	10,828
2025	20	55	2	9,306
2026	12	63	4	—

What is it indicated for?

The Vanguard T M Patella is intended use is for replacement of part of the knee joint in conjunction with a femoral and tibial component. Specifically:

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

2. Correction of varus, valgus or posttraumatic deformity.

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

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K040770 · printed Nov 5, 2026

Cite this page

510(k) Report. “K040770: Vanguard 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/K040770

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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