510(k) · Cleared
ClearedVanguard PS Open Box Porous Femoral Components
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Manufacturing Corp · MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Cleared on Mar 30, 2006 as substantially equivalent to K023546 (Biomet, Inc., 2003) and 1 other predicate after a 52-day review. Its family tree reaches back 3 generations to 1992. 47 later devices descend from it.
- Decided
- Mar 30, 2006
- Review
- 52 days
- Class
- Class II
- Product code
- MBH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K915132 (1992). 18 ancestors in all, the oldest K833921 (1984). 47 later devices descend from it, 2 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 backK033489 Agc Total Knee System Knee, Ascent Total Knee System, Maxim Complete…Biomet, Inc. · 2004
- This deviceK060303 Vanguard PS Open Box Porous Femoral ComponentsBiomet Manufacturing Corp · 2006
- Descendant · cites it directly · 46 of its ownK113550 Vanguard Complete Knee SystemBiomet Manufacturing Corp · 2012 · Recalled
- Descendant · 2 generations on · 8 of its ownK221479 Persona Personalized Knee SystemZimmer, Inc. · 2022
- Descendant · 2 generations on · 8 of its ownK151266 Physica CR Knee SystemLima Corporate S.P.A. · 2015
- Descendant · 2 generations on · 7 of its ownK152008 Physica PS Knee SystemLima Corporate S.P.A. · 2015
- Descendant · 2 generations on · 6 of its ownK193284 Physica LMC Knee SystemLima Corporate S.P.A. · 2020
Showing 5 of 47 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 47 · See all- K113550Vanguard Complete Knee SystemBiomet Manufacturing Corp · 2012 · cites it directly46descendants
- K221479Persona Personalized Knee SystemZimmer, Inc. · 2022 · 2 generations on8descendants
- K151266Physica CR Knee SystemLima Corporate S.P.A. · 2015 · 2 generations on8descendants
- K152008Physica PS Knee SystemLima Corporate S.P.A. · 2015 · 2 generations on7descendants
- K193284Physica LMC Knee SystemLima Corporate S.P.A. · 2020 · 2 generations on6descendants
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 | K033489 | Agc Total Knee System Knee, Ascent Total Knee System, Maxim Complete Knee… | Biomet, Inc. | 2004 | — |
| 0 (this device) | K060303 | Vanguard PS Open Box Porous Femoral Components | Biomet Manufacturing Corp | 2006 | — |
| +1 | K113550 | Vanguard Complete Knee System | Biomet Manufacturing Corp | 2012 | 7 |
| +2 | K221479 | Persona Personalized Knee System | Zimmer, Inc. | 2022 | — |
| +2 | K151266 | Physica CR Knee System | Lima Corporate S.P.A. | 2015 | — |
| +2 | K152008 | Physica PS Knee System | Lima Corporate S.P.A. | 2015 | — |
| +2 | K193284 | Physica LMC Knee System | Lima Corporate S.P.A. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1986 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 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 |
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 MBH? 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 MBH device
- #1 K241597 Freedom® Total Knee System - Porous Tibial…score 20.0 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 | Decided |
|---|---|---|---|
| * | K023546 | Maxim Accel Knee SystemSummary page 1…femorotibial metal/polymer porous-coated uncemented prosthesis (888.3565) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Maxim® Accel Knee System (K023546); Non-Cemented Porous Coated Knees (K033489) Device Description: The Vanguard TM PS Open Box Porous Femoral Components described… | 2003 |
| * | K033489 | Agc Total Knee System Knee, Ascent Total Knee System, Maxim Complete Knee System, Maxim…Summary page 1…emented prosthesis (888.3565) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Maxim® Accel Knee System (K023546); Non-Cemented Porous Coated Knees (K033489) Device Description: The Vanguard TM PS Open Box Porous Femoral Components described in this submission have the same articulatin… | 2004 |
What descends from it? (47)
See all 472 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 14 years and passes through 2 companies; a new generation was cleared every 1.8 years on median.
- 6 of the 18 ancestors have a recall of any class.
- Of its descendants, K113550 (Biomet Manufacturing Corp, 2012) has gone furthest, with 46 descendants of its own.
- 14 other devices also cite its predicate K023546.
How does its category compare?
All MBH devicesMBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MBH
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MBH
98in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MBH
1in 2024
Class I (5 since 2007) Class II/III not classified
Adverse event reports per year · MBH
1,561in 2025
MAUDE reports naming product code MBH, 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 | 10 | 59 | 0 | 27 |
| 2008 | 3 | 70 | 0 | 21 |
| 2009 | 3 | 209 | 2 | 89 |
| 2010 | 4 | 84 | 0 | 121 |
| 2011 | 5 | 84 | 15 | 247 |
| 2012 | 5 | 90 | 1 (1) | 370 |
| 2013 | 6 | 138 | 4 (4) | 308 |
| 2014 | 9 | 114 | 0 | 385 |
| 2015 | 8 | 100 | 0 | 955 |
| 2016 | 4 | 74 | 1 | 1,034 |
| 2017 | 4 | 115 | 9 | 1,007 |
| 2018 | 6 | 89 | 1 | 1,191 |
| 2019 | 1 | — | 1 | 1,394 |
| 2020 | 7 | 112 | 2 | 1,089 |
| 2021 | 6 | 48 | 0 | 1,539 |
| 2022 | 7 | 57 | 0 | 1,261 |
| 2023 | 6 | 94 | 2 | 1,263 |
| 2024 | 10 | 84 | 1 | 1,497 |
| 2025 | 8 | 98 | 0 | 1,561 |
| 2026 | 7 | 153 | 4 | — |
What is it indicated for?
The VanguardTM PS Open Box Porous Femoral Components are indicated for cemented or non-cemented use in cases of:
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060303 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060303: Vanguard PS Open Box Porous Femoral Components.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060303
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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