510(k) · Cleared
Recalled · Class II · 2016Vanguard XP Femoral Component (Gen II)/Vanguard XP Femoral Trial
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 Oct 27, 2014 as substantially equivalent to K132873 (Biomet, Inc., 2013) and 3 other predicates after a 152-day review. Its family tree reaches back 9 generations to 1981. 2 later devices descend from it. It has been recalled once.
- Decided
- Oct 27, 2014
- Review
- 152 days
- Class
- Class II
- Product code
- MBH
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 9 generations to K810258 (1981). 56 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 5 generations between
- 3 generations backK113550 Vanguard Complete Knee SystemBiomet Manufacturing Corp · 2012 · Recalled
- 2 generations backK122160 Vanguard XP Knee SystemBiomet Manufacturing Corp · 2013 · Recalled
- 1 generation backK132873 Vanguard XP Knee SystemBiomet, Inc. · 2013 · Recalled
- This deviceK141407 Vanguard XP Femoral Component (Gen II)/Vanguard XP Femoral TrialBiomet, Inc. · 2014
- Descendant · cites it directly · 1 of its ownK153657 Vanguard XP Knee SystemBiomet, Inc. · 2016 · Recalled
- Descendant · cites it directly · 0 of its ownK190068 Vanguard XP Knee SystemZimmer, Inc. · 2019
Show all 9 generations
- Root · 9 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 8 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
- 7 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
- 6 generations backK050327 E-Poly (Vitamin E) Acetabular LinersBiomet, Inc. · 2005
- 5 generations backK070364 100KGY E-Poly Maxrom Acetabular LinersBiomet, Inc. · 2007
- 4 generations backK080528 E-Poly Tibial BearingsBiomet Orthopedics, Inc. · 2008
- 3 generations backK113550 Vanguard Complete Knee SystemBiomet Manufacturing Corp · 2012 · Recalled
- 2 generations backK122160 Vanguard XP Knee SystemBiomet Manufacturing Corp · 2013 · Recalled
- 1 generation backK132873 Vanguard XP Knee SystemBiomet, Inc. · 2013 · Recalled
- This deviceK141407 Vanguard XP Femoral Component (Gen II)/Vanguard XP Femoral TrialBiomet, Inc. · 2014
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K810258 | Proximal Fermoral Hip Replacement | Biomet, Inc. | 1981 | — |
| −8 | K974558 | Salvage/Onocology Hip and Total Femur System | Biomet, Inc. | 1998 | — |
| −7 | K032396 | Ringloc 36MM Line and Modular Femoral Heads | Biomet, Inc. | 2003 | 3 |
| −6 | K050327 | E-Poly (Vitamin E) Acetabular Liners | Biomet, Inc. | 2005 | — |
| −5 | K070364 | 100KGY E-Poly Maxrom Acetabular Liners | Biomet, Inc. | 2007 | — |
| −4 | K080528 | E-Poly Tibial Bearings | Biomet Orthopedics, Inc. | 2008 | — |
| −3 | K113550 | Vanguard Complete Knee System | Biomet Manufacturing Corp | 2012 | 7 |
| −2 | K122160 | Vanguard XP Knee System | Biomet Manufacturing Corp | 2013 | 12 |
| −1 | K132873 | Vanguard XP Knee System | Biomet, Inc. | 2013 | 22 |
| 0 (this device) | K141407 | Vanguard XP Femoral Component (Gen II)/Vanguard XP Femoral Trial | Biomet, Inc. | 2014 | — |
| +1 | K153657 | Vanguard XP Knee System | Biomet, Inc. | 2016 | 1 |
| +1 | K190068 | Vanguard XP Knee System | Zimmer, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 2 | 0 |
| 1986 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 3 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 7 | 0 |
| 1996 | 3 | 0 |
| 1997 | 3 | 0 |
| 1998 | 1 | 0 |
| 1999 | 4 | 0 |
| 2000 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 5 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2019 | 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 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? (4)
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 |
|---|---|---|---|
| * | K132873 | Vanguard XP Knee SystemSummary page 4…21CFR §888.3560 Product Code(s) JWH, MBH, MBV, OIY Legally marketed device(s) to which equivalence is K132873 Vanguard XP Knee System (JWH, MBH, MBV, OIY) claimed K122160 Vanguard XP Knee System (JWH, MBH… | 2013 |
| * | K122160 | Vanguard XP Knee SystemSummary page 4…OIY Legally marketed device(s) to which equivalence is K132873 Vanguard XP Knee System (JWH, MBH, MBV, OIY) claimed K122160 Vanguard XP Knee System (JWH, MBH, MBV, OIY) K113550 Vanguard Knee System (JWH, MBH, O… | 2013 |
| * | K113550 | Vanguard Complete Knee SystemSummary page 4…ee System (JWH, MBH, MBV, OIY) claimed K122160 Vanguard XP Knee System (JWH, MBH, MBV, OIY) K113550 Vanguard Knee System (JWH, MBH, OIY) K904448 Townley Total Knee (JWH) Reason for 510(… | 2012 |
| * | K904448 | Townley Total Knee (TTK)Summary page 4…rd XP Knee System (JWH, MBH, MBV, OIY) K113550 Vanguard Knee System (JWH, MBH, OIY) K904448 Townley Total Knee (JWH) Reason for 510(k) Line Extension of XP Femoral Component submission Mailing Ad… | 1991 |
What descends from it? (2)
2 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 |
|---|---|---|---|---|
| Feb 5, 2016 | Class II | Z-1265-2016 | Device Design | The anterior/posterior (AP) dimension may be oversized by 0.016 . If the femoral component does not fit as tightly as intended, bony ingrowth may not occur causing loosening of the femoral component. A revision surgery may be necessary. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 33 years and passes through 3 companies; a new generation was cleared every 1.6 years on median.
- 22 of the 56 ancestors have a recall of any class.
- Of its descendants, K153657 (Biomet, Inc., 2016) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K132873.
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. 2014, this device’s year, is highlighted.
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, or 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. Femoral components and tibial tray components with porous coatings are indicated for cemented and uncemented…
Read the full statement (93 words)
1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, or 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.
Femoral components and tibial tray components with porous coatings are indicated for cemented and uncemented biological fixation application. Non-coated (Interlok) femoral components, tibial tray components and all polyethylene patellar components are indicated for cemented application only. Regenerex components* are intended only for uncemented biologic fixation application.
*Where Available
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141407 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141407: Vanguard XP Femoral Component (Gen II)/Vanguard XP Femoral Trial.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141407
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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