510(k) · Cleared
ClearedVanguard Knee System Titanium Femoral Components
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet, Inc. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Mar 20, 2008 as substantially equivalent to K981996 (Biomet, Inc., 1999) and 2 other predicates after a 52-day review. Its family tree reaches back 3 generations to 1992. 6 later devices descend from it.
- Decided
- Mar 20, 2008
- Review
- 52 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K915132 (1992). 5 ancestors in all. 6 later devices descend from it, 1 citing it directly.
- 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 backK042757 Vanguard SSK Knee SystemBiomet, Inc. · 2005 · Recalled
- This deviceK080204 Vanguard Knee System Titanium Femoral ComponentsBiomet, Inc. · 2008
- 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 · 1 of its ownK191625 Persona Revision Knee SystemZimmer, Inc. · 2019 · Recalled
- Descendant · 3 generations on · 0 of its ownK243724 Persona® Revision Knee System (Persona Revision SoluTion™ Femoral…Zimmer, Inc. · 2025
- 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
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
| 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 | K042757 | Vanguard SSK Knee System | Biomet, Inc. | 2005 | 1 |
| 0 (this device) | K080204 | Vanguard Knee System Titanium Femoral Components | Biomet, Inc. | 2008 | — |
| +1 | K171054 | Biomet Knee Joint Replacement Prostheses | Biomet, Inc. | 2017 | 4 |
| +2 | K181947 | Persona Revision Knee System | Zimmer, Inc. | 2018 | 1 |
| +3 | K191625 | Persona Revision Knee System | Zimmer, Inc. | 2019 | 1 |
| +3 | K243724 | Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components) | Zimmer, Inc. | 2025 | — |
| +3 | K210829 | Persona Revision Knee System Femoral Metaphyseal Cones | Zimmer, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 2 | 0 |
| 2025 | 1 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K981996 | Titanium Femoral ComponentSummary page 1…constrained cemented prosthesis (21 CFR § 888.3560) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Biomet Titanium Femoral Component - K98 1996 (Biomet inc.) Maxim® Accel Knee System - K023 546 (Biomet Inc.) Vanguard Tm SSK Knee System - K042757 (Biomet Inc.) Device Descr… | 1999 |
| * | K023546 | Maxim Accel Knee SystemSummary page 1…§ 888.3560) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Biomet Titanium Femoral Component - K98 1996 (Biomet inc.) Maxim® Accel Knee System - K023 546 (Biomet Inc.) Vanguard Tm SSK Knee System - K042757 (Biomet Inc.) Device Description: The Vanguardt Kne System Titanium Femoral… | 2003 |
| * | K042757 | Vanguard SSK Knee SystemSummary page 1…antial Equivalence Is Claimed: Biomet Titanium Femoral Component - K98 1996 (Biomet inc.) Maxim® Accel Knee System - K023 546 (Biomet Inc.) Vanguard Tm SSK Knee System - K042757 (Biomet Inc.) Device Description: The Vanguardt Kne System Titanium Femoral Components have the same design as the predicate Van… | 2005 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171054 | Biomet Knee Joint Replacement Prostheses | 2017 | 5 |
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 16 years and passes through 1 company; a new generation was cleared every 3.1 years on median.
- 3 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.
- 2 other devices also cite its predicate K981996.
How does its category compare?
All JWH devicesJWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · JWH
20in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JWH
55in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JWH
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JWH
9,306in 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, or traumatic arthritis where one or more compartments are involved.
2. Failure of previous joint replacement procedure.
3. Correction of varus/valgus or post-traumatic deformity.
4. Correction or revision of unsuccessful osteotomy, or arthrodesis.
* Device designed for use in patients with metal sensitivity.
* Standard surgical and rehabilitative procedures are indicated with this device.
* The device is a single-use device intended for use with bone cement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080204 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080204: Vanguard Knee System Titanium Femoral Components.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080204
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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