510(k) · Cleared

Recalled · Class II · 2020

Vanguard Removable Molded Poly Tibia

K060525510(k) TraditionalCleared May 25, 200687-day reviewClass II21 CFR 888.3560Recalls 3

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

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

Cleared on May 25, 2006 as substantially equivalent to K991753 (Biomet, Inc., 1999) and 2 other predicates after an 87-day review. Its family tree reaches back 2 generations to 1992. 16 later devices descend from it. It has been recalled 3 times.

Decided: May 25, 2006
Review: 87 days
Class: Class II
Product code: JWH
Recalls: 3
Predicates: 3

Its longest line of descent runs back 2 generations to K915132 (1992). 5 ancestors in all. 16 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 2 generations backK915132 MCK Maximum Congruent Knee) Knee SystemBiomet, Inc. · 1992 · Recalled
1 generation backK023546 Maxim Accel Knee SystemBiomet, Inc. · 2003 · Recalled
This deviceK060525 Vanguard Removable Molded Poly TibiaBiomet Manufacturing Corp · 2006
Descendant · cites it directly · 9 of its ownK102580 Vanguard Removable Molded Poly TibiaBiomet Manufacturing Corp · 2011
Descendant · 2 generations on · 6 of its ownK122160 Vanguard XP Knee SystemBiomet Manufacturing Corp · 2013 · Recalled
Descendant · cites it directly · 5 of its ownK171054 Biomet Knee Joint Replacement ProsthesesBiomet, Inc. · 2017 · Recalled
Descendant · 2 generations on · 4 of its ownK181947 Persona Revision Knee SystemZimmer, Inc. · 2018 · Recalled
Descendant · 3 generations on · 3 of its ownK132873 Vanguard XP Knee SystemBiomet, Inc. · 2013 · Recalled

Showing 5 of 16 descendants. See all descendants

Descendants cleared per year

2011high 2 (2013) · low 0 (2012)2026

Most influential descendants

Showing 5 of 16 · See all

K102580Vanguard Removable Molded Poly TibiaBiomet Manufacturing Corp · 2011 · cites it directly9descendants
K122160Vanguard XP Knee SystemBiomet Manufacturing Corp · 2013 · 2 generations on6descendants
K171054Biomet Knee Joint Replacement ProsthesesBiomet, Inc. · 2017 · cites it directly5descendants
K181947Persona Revision Knee SystemZimmer, Inc. · 2018 · 2 generations on4descendants
K132873Vanguard XP Knee SystemBiomet, Inc. · 2013 · 3 generations on3descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K915132	MCK Maximum Congruent Knee) Knee System	Biomet, Inc.	1992	6
−1	K023546	Maxim Accel Knee System	Biomet, Inc.	2003	13
0 (this device)	K060525	Vanguard Removable Molded Poly Tibia	Biomet Manufacturing Corp	2006	—
+1	K102580	Vanguard Removable Molded Poly Tibia	Biomet Manufacturing Corp	2011	—
+2	K122160	Vanguard XP Knee System	Biomet Manufacturing Corp	2013	12
+1	K171054	Biomet Knee Joint Replacement Prostheses	Biomet, Inc.	2017	4
+2	K181947	Persona Revision Knee System	Zimmer, Inc.	2018	1
+3	K132873	Vanguard XP Knee System	Biomet, Inc.	2013	22

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	1	0
1999	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	1	0
2013	2	0
2014	2	0
2015	2	0
2016	1	0
2017	1	0
2018	1	0
2019	2	0
2021	2	0
2025	1	0
2026	1	0

FIG. 1 — Lineage of K060525, 1992–2026Source: 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? (3)

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
*	K991753	Maxim Removable Molded Poly Tibia Summary page 1 …polymer/metal/polymer (888.3560) Legally Marketed Devices To Which Substantial Equivalence is Claimed: Maxim® Removable Molded Polyethylene Tibia (Pop-Top) - K991753 and K984623 (Biomet, Inc.): Vanguard TM System- K023546 (Biomet, Inc.) Device Description: Vanguard Removable Molded Polyethylen…	Biomet, Inc.	1999	—
*	K984623	Maxim Removable Molded Poly Tibia Summary page 1 …olymer/metal/polymer (888.3560) Legally Marketed Devices To Which Substantial Equivalence is Claimed: Maxim® Removable Molded Polyethylene Tibia (Pop-Top) - K991753 and K984623 (Biomet, Inc.): Vanguard TM System- K023546 (Biomet, Inc.) Device Description: Vanguard Removable Molded Polyethylene Tibia is i…	Biomet, Inc.	1999	—
*	K023546	Maxim Accel Knee System Summary page 1 …keted Devices To Which Substantial Equivalence is Claimed: Maxim® Removable Molded Polyethylene Tibia (Pop-Top) - K991753 and K984623 (Biomet, Inc.): Vanguard TM System- K023546 (Biomet, Inc.) Device Description: Vanguard Removable Molded Polyethylene Tibia is intended to replace…	Biomet, Inc.	2003	13

What descends from it? (16)

See all 16

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

Number	Device	Applicant	Decided	Descendants
K102580	Vanguard Removable Molded Poly Tibia	Biomet Manufacturing Corp	2011	9
K171054	Biomet Knee Joint Replacement Prostheses	Biomet, Inc.	2017	5

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-2152-2020	Process control	Potential presence of elevated endotoxin levels that exceed the specification limit
Apr 17, 2020	Class II	Z-2151-2020	Process control	Potential presence of elevated endotoxin levels that exceed the specification limit
Feb 17, 2017	Class II	Z-1861-2017	Process design	Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 14 years and passes through 2 companies; a new generation was cleared every 10.9 years on median.
2 of the 5 ancestors have a recall of any class.
Of its descendants, K102580 (Biomet Manufacturing Corp, 2011) has gone furthest, with 9 descendants of its own.

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?

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.

The device is a single use implant intended for use with bone cement.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K060525 · printed Nov 5, 2026

Cite this page

510(k) Report. “K060525: Vanguard Removable Molded Poly Tibia.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K060525

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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