510(k) · Cleared

Cleared

Vanguard Removable Molded Poly Tibia

K102580510(k) TraditionalCleared Mar 3, 2011176-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 Manufacturing Corp · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Cleared on Mar 3, 2011 as substantially equivalent to K060525 (Biomet Manufacturing Corp, 2006) and 1 other predicate after a 176-day review. Its family tree reaches back 3 generations to 1992. 9 later devices descend from it.

Decided: Mar 3, 2011
Review: 176 days
Class: Class II
Product code: JWH
Recalls: None
Predicates: 2

Its longest line of descent runs back 3 generations to K915132 (1992). 6 ancestors in all. 9 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 3 generations backK915132 MCK Maximum Congruent Knee) Knee SystemBiomet, Inc. · 1992 · Recalled
2 generations backK023546 Maxim Accel Knee SystemBiomet, Inc. · 2003 · Recalled
1 generation backK060525 Vanguard Removable Molded Poly TibiaBiomet Manufacturing Corp · 2006 · Recalled
This deviceK102580 Vanguard Removable Molded Poly TibiaBiomet Manufacturing Corp · 2011
Descendant · cites it directly · 6 of its ownK122160 Vanguard XP Knee SystemBiomet Manufacturing Corp · 2013 · Recalled
Descendant · 2 generations on · 3 of its ownK132873 Vanguard XP Knee SystemBiomet, Inc. · 2013 · Recalled
Descendant · 2 generations on · 2 of its ownK141407 Vanguard XP Femoral Component (Gen II)/Vanguard XP Femoral TrialBiomet, Inc. · 2014 · Recalled
Descendant · 2 generations on · 1 of its ownK153657 Vanguard XP Knee SystemBiomet, Inc. · 2016 · Recalled
Descendant · cites it directly · 1 of its ownK142814 Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral &…Biomet Manufacturing, LLC · 2015 · Recalled

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2013high 2 (2013) · low 0 (2017)2026

Most influential descendants

Showing 5 of 9 · See all

K122160Vanguard XP Knee SystemBiomet Manufacturing Corp · 2013 · cites it directly6descendants
K132873Vanguard XP Knee SystemBiomet, Inc. · 2013 · 2 generations on3descendants
K141407Vanguard XP Femoral Component (Gen II)/Vanguard XP Femoral TrialBiomet, Inc. · 2014 · 2 generations on2descendants
K153657Vanguard XP Knee SystemBiomet, Inc. · 2016 · 2 generations on1descendant
K142814Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid TibialBiomet Manufacturing, LLC · 2015 · cites it directly1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K915132	MCK Maximum Congruent Knee) Knee System	Biomet, Inc.	1992	6
−2	K023546	Maxim Accel Knee System	Biomet, Inc.	2003	13
−1	K060525	Vanguard Removable Molded Poly Tibia	Biomet Manufacturing Corp	2006	3
0 (this device)	K102580	Vanguard Removable Molded Poly Tibia	Biomet Manufacturing Corp	2011	—
+1	K122160	Vanguard XP Knee System	Biomet Manufacturing Corp	2013	12
+2	K132873	Vanguard XP Knee System	Biomet, Inc.	2013	22
+2	K141407	Vanguard XP Femoral Component (Gen II)/Vanguard XP Femoral Trial	Biomet, Inc.	2014	1
+2	K153657	Vanguard XP Knee System	Biomet, Inc.	2016	1
+1	K142814	Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid Tibial	Biomet Manufacturing, LLC	2015	6

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
2013	2	0
2014	2	0
2015	2	0
2016	1	0
2019	1	0
2026	1	0

FIG. 1 — Lineage of K102580, 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? (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
*	K060525	Vanguard Removable Molded Poly Tibia Summary page 1 …etal/polymer semi- constrained cemented prosthesis (21CFR §888.3560) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: K060525 Vanguard Removable Molded Poly Tibia Biomet Manufacturing Corp. K915132 MCK [Maxim] Knee System…	Biomet Manufacturing Corp	2006	3
*	K915132	MCK Maximum Congruent Knee) Knee System Summary page 1 …3560) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: K060525 Vanguard Removable Molded Poly Tibia Biomet Manufacturing Corp. K915132 MCK [Maxim] Knee System Biomet Manufacturing Corp. Device Description: The Vanguard® Removable M…	Biomet, Inc.	1992	6

Also cleared against K060525: 1 other device →

What descends from it? (9)

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

Number	Device	Applicant	Decided	Descendants
K122160	Vanguard XP Knee System	Biomet Manufacturing Corp	2013	6
K142814	Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid Tibial	Biomet Manufacturing, LLC	2015	1

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 19 years and passes through 2 companies; a new generation was cleared every 4.8 years on median.
3 of the 6 ancestors have a recall of any class.
Of its descendants, K122160 (Biomet Manufacturing Corp, 2013) has gone furthest, with 6 descendants of its own.
1 other device also cites its predicate K060525.

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. 2011, this device’s year, is highlighted.

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® Cruciate Molded Poly Tibia is intended for:

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

2. Failure of a previous joint replacement procedure

3. Correction of varus, valgus, or post traumatic deformity;

4. Correction or revision of unsuccessful osteotomy or arthrodesis.

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/K102580 · printed Nov 6, 2026

Cite this page

510(k) Report. “K102580: Vanguard Removable Molded Poly Tibia.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102580

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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