510(k) · Cleared
ClearedPatient-Specific Vanguard Femoral Componets
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 Feb 23, 2011 as substantially equivalent to K023546 (Biomet, Inc., 2003) after a 209-day review. Its family tree reaches back 2 generations to 1992. 6 later devices descend from it.
- Decided
- Feb 23, 2011
- Review
- 209 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K915132 (1992). 3 ancestors in all. 6 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK915132 MCK Maximum Congruent Knee) Knee SystemBiomet, Inc. · 1992 · Recalled
- 1 generation backK023546 Maxim Accel Knee SystemBiomet, Inc. · 2003 · Recalled
- This deviceK102125 Patient-Specific Vanguard Femoral ComponetsBiomet, Inc. · 2011
- 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 |
|---|---|---|---|---|---|
| −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) | K102125 | Patient-Specific Vanguard Femoral Componets | Biomet, Inc. | 2011 | — |
| +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 |
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? (1)
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 |
|---|---|---|---|
| * | K023546 | Maxim Accel Knee SystemSummary page 1…Product Code: JWH Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Maxim® Acel Knee System Interlok®'Femoral Components - K023546 Biomet Device Description: The Patient-Specific Vanguard T"Femoral Components are comprised of a series of CoCrMo… | 2003 |
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 19 years and passes through 1 company; a new generation was cleared every 10.9 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K171054 (Biomet, Inc., 2017) has gone furthest, with 5 descendants of its own.
- 14 other devices also cite its predicate K023546.
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. 2011, 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?
The indications for the Patient-Specific VanguardTM Femurs are as follows:
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 total joint replacement procedure.
These devices are single-use implants intended for cemented use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102125 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102125: Patient-Specific Vanguard Femoral Componets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102125
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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