510(k) · Cleared
Recalled · Class II · 2024Vanguard Anterior Stabilized Tibial Bearings
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet, Inc. · MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Cleared on Aug 16, 2005 as substantially equivalent to K023546 (Biomet, Inc., 2003) after a 197-day review. Its family tree reaches back 2 generations to 1992. 255 later devices descend from it. It has been recalled once.
- Decided
- Aug 16, 2005
- Review
- 197 days
- Class
- Class II
- Product code
- MBH
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K915132 (1992). 3 ancestors in all. 255 later devices descend from it, 7 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 deviceK050222 Vanguard Anterior Stabilized Tibial BearingsBiomet, Inc. · 2005
- Descendant · cites it directly · 248 of its ownK080528 E-Poly Tibial BearingsBiomet Orthopedics, Inc. · 2008
- Descendant · 2 generations on · 119 of its ownK091956 Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model…Encore Medical L.P. · 2010 · Recalled
- Descendant · 2 generations on · 114 of its ownK100048 E1 Antioxidant Infused TechnologyBiomet Manufacturing Corp · 2010
- Descendant · 3 generations on · 88 of its ownK120370 Vivacit-E Vitamin E Highly Crosslinked Polyethylene LinersZimmer, Inc. · 2012
- Descendant · 3 generations on · 59 of its ownK121771 Zimmer Persona the Personalized Knee SystemZimmer, Inc. · 2012 · Recalled
Showing 5 of 255 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 255 · See all- K080528E-Poly Tibial BearingsBiomet Orthopedics, Inc. · 2008 · cites it directly248descendants
- K091956Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model 391/392-09_19-702_712Encore Medical L.P. · 2010 · 2 generations on119descendants
- K100048E1 Antioxidant Infused TechnologyBiomet Manufacturing Corp · 2010 · 2 generations on114descendants
- K120370Vivacit-E Vitamin E Highly Crosslinked Polyethylene LinersZimmer, Inc. · 2012 · 3 generations on88descendants
- K121771Zimmer Persona the Personalized Knee SystemZimmer, Inc. · 2012 · 3 generations on59descendants
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) | K050222 | Vanguard Anterior Stabilized Tibial Bearings | Biomet, Inc. | 2005 | — |
| +1 | K080528 | E-Poly Tibial Bearings | Biomet Orthopedics, Inc. | 2008 | — |
| +2 | K091956 | Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model 391/392-09_19-702_712 | Encore Medical L.P. | 2010 | 4 |
| +2 | K100048 | E1 Antioxidant Infused Technology | Biomet Manufacturing Corp | 2010 | — |
| +3 | K120370 | Vivacit-E Vitamin E Highly Crosslinked Polyethylene Liners | Zimmer, Inc. | 2012 | — |
| +3 | K121771 | Zimmer Persona the Personalized Knee System | Zimmer, Inc. | 2012 | 2 |
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 |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 2 | 0 |
| 2012 | 9 | 0 |
| 2013 | 12 | 0 |
| 2014 | 16 | 0 |
| 2015 | 11 | 0 |
| 2016 | 15 | 0 |
| 2017 | 9 | 0 |
| 2018 | 12 | 0 |
| 2019 | 17 | 0 |
| 2020 | 19 | 0 |
| 2021 | 24 | 0 |
| 2022 | 21 | 0 |
| 2023 | 19 | 0 |
| 2024 | 21 | 0 |
| 2025 | 24 | 0 |
| 2026 | 20 | 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 19.9 · 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? (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…hesis (§888.3565). Legally Marketed Devices To Which Substantial Equivalence Is Claimed: T M) CR - Lipped Tibial Bearings - K023546 Maxim Accel (Vanguard Device Description: The Vanguard Tm Anterior Stabilized Tibial Bearings are int… | 2003 |
What descends from it? (255)
See all 2557 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 13, 2024 | Class II | Z-1607-2024 | Process change control | Possible damage to the Vanguard Knee System AS Tibial Bearing caused during the manufacturing process. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 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, K080528 (Biomet Orthopedics, Inc., 2008) has gone furthest, with 248 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?
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.
Femoral components and tibial tray components with porous coating are indicated for cemented and uncemented biological fixation application. Non-coated (Interlok®) devices and all polyethylene patellar components are indicated for cemented application only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050222 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050222: Vanguard Anterior Stabilized Tibial Bearings.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050222
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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