510(k) · Cleared
Recalled · Class II · 2022Vanguard Complete Knee System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Manufacturing Corp · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Feb 29, 2012 as substantially equivalent to K023546 (Biomet, Inc., 2003) and 6 other predicates after a 90-day review. Its family tree reaches back 6 generations to 1981. 46 later devices descend from it. It has been recalled 7 times.
- Decided
- Feb 29, 2012
- Review
- 90 days
- Class
- Class II
- Product code
- JWH
- Recalls
- 7
- Predicates
- 7
Its longest line of descent runs back 6 generations to K810258 (1981). 40 ancestors in all. 46 later devices descend from it, 18 citing it directly.
- Root · 6 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 5 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
- 4 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
- 3 generations backK050327 E-Poly (Vitamin E) Acetabular LinersBiomet, Inc. · 2005
- 2 generations backK070364 100KGY E-Poly Maxrom Acetabular LinersBiomet, Inc. · 2007
- 1 generation backK080528 E-Poly Tibial BearingsBiomet Orthopedics, Inc. · 2008
- This deviceK113550 Vanguard Complete Knee SystemBiomet Manufacturing Corp · 2012
- Descendant · cites it directly · 8 of its ownK221479 Persona Personalized Knee SystemZimmer, Inc. · 2022
- Descendant · cites it directly · 8 of its ownK151266 Physica CR Knee SystemLima Corporate S.P.A. · 2015
- Descendant · cites it directly · 7 of its ownK152008 Physica PS Knee SystemLima Corporate S.P.A. · 2015
- Descendant · cites it directly · 6 of its ownK193284 Physica LMC Knee SystemLima Corporate S.P.A. · 2020
- Descendant · cites it directly · 6 of its ownK122160 Vanguard XP Knee SystemBiomet Manufacturing Corp · 2013 · Recalled
Showing 5 of 46 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 46 · See all- K221479Persona Personalized Knee SystemZimmer, Inc. · 2022 · cites it directly8descendants
- K151266Physica CR Knee SystemLima Corporate S.P.A. · 2015 · cites it directly8descendants
- K152008Physica PS Knee SystemLima Corporate S.P.A. · 2015 · cites it directly7descendants
- K193284Physica LMC Knee SystemLima Corporate S.P.A. · 2020 · cites it directly6descendants
- K122160Vanguard XP Knee SystemBiomet Manufacturing Corp · 2013 · cites it directly6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K810258 | Proximal Fermoral Hip Replacement | Biomet, Inc. | 1981 | — |
| −5 | K974558 | Salvage/Onocology Hip and Total Femur System | Biomet, Inc. | 1998 | — |
| −4 | K032396 | Ringloc 36MM Line and Modular Femoral Heads | Biomet, Inc. | 2003 | 3 |
| −3 | K050327 | E-Poly (Vitamin E) Acetabular Liners | Biomet, Inc. | 2005 | — |
| −2 | K070364 | 100KGY E-Poly Maxrom Acetabular Liners | Biomet, Inc. | 2007 | — |
| −1 | K080528 | E-Poly Tibial Bearings | Biomet Orthopedics, Inc. | 2008 | — |
| 0 (this device) | K113550 | Vanguard Complete Knee System | Biomet Manufacturing Corp | 2012 | — |
| +1 | K221479 | Persona Personalized Knee System | Zimmer, Inc. | 2022 | — |
| +1 | K151266 | Physica CR Knee System | Lima Corporate S.P.A. | 2015 | — |
| +1 | K152008 | Physica PS Knee System | Lima Corporate S.P.A. | 2015 | — |
| +1 | K193284 | Physica LMC Knee System | Lima Corporate S.P.A. | 2020 | — |
| +1 | K122160 | Vanguard XP Knee System | Biomet Manufacturing Corp | 2013 | 12 |
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 |
| 1992 | 3 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 6 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 4 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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? (7)
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…semi-constrained cemented prosthesis (2ICFR §888.3560) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: K023 546 Vanguard® CR Knee System K033489 Vanguard® CR Knee System K04 1046 Vanguard®D PS± Beari… | 2003 |
| * | K033489 | Agc Total Knee System Knee, Ascent Total Knee System, Maxim Complete Knee System, Maxim…Summary page 1…esis (2ICFR §888.3560) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: K023 546 Vanguard® CR Knee System K033489 Vanguard® CR Knee System K04 1046 Vanguard®D PS± Bearings K050222 Vanguard® AS Tibial B… | 2004 |
| * | K041046 | Maxim Accel (Vanguard) PS+ BearingsSummary page 1…ich Substantial Equivalence Is Claimed: K023 546 Vanguard® CR Knee System K033489 Vanguard® CR Knee System K04 1046 Vanguard®D PS± Bearings K050222 Vanguard® AS Tibial Bearings K060303 Vanguard®'PS Open… | 2004 |
| * | K050222 | Vanguard Anterior Stabilized Tibial BearingsSummary page 1…K023 546 Vanguard® CR Knee System K033489 Vanguard® CR Knee System K04 1046 Vanguard®D PS± Bearings K050222 Vanguard® AS Tibial Bearings K060303 Vanguard®'PS Open Box Porous Femoral K06 1340 Vang… | 2005 |
| * | K060303 | Vanguard PS Open Box Porous Femoral ComponentsSummary page 1…K033489 Vanguard® CR Knee System K04 1046 Vanguard®D PS± Bearings K050222 Vanguard® AS Tibial Bearings K060303 Vanguard®'PS Open Box Porous Femoral K06 1340 Vanguard@ Single Peg Patella K080528 El®… | 2006 |
| * | K061340 | 23 MM Single-Peg Patella ComponentSummary page 1…Vanguard®D PS± Bearings K050222 Vanguard® AS Tibial Bearings K060303 Vanguard®'PS Open Box Porous Femoral K06 1340 Vanguard@ Single Peg Patella K080528 El® Tibial Components (previously E-poly)… | 2006 |
| * | K080528 | E-Poly Tibial BearingsSummary page 1…ard® AS Tibial Bearings K060303 Vanguard®'PS Open Box Porous Femoral K06 1340 Vanguard@ Single Peg Patella K080528 El® Tibial Components (previously E-poly) Section III - Page I of 2… | 2008 |
What descends from it? (46)
See all 4618 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K221479 | Persona Personalized Knee System | 2022 | 8 |
| K151266 | Physica CR Knee System | 2015 | 8 |
| K152008 | Physica PS Knee System | 2015 | 7 |
| K193284 | Physica LMC Knee System | 2020 | 6 |
| K122160 | Vanguard XP Knee System | 2013 | 6 |
| K201084 | Physica system | 2020 | 5 |
| K171054 | Biomet Knee Joint Replacement Prostheses | 2017 | 5 |
| K122883 | Exp Tibial Inserts and Patellar Components for the Proven Gen-Flex Total Knee System | 2013 | 4 |
| K132873 | Vanguard XP Knee System | 2013 | 3 |
| K210554 | Physica system | 2021 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 29, 2022 | Class II | Z-1042-2023 | Labeling Change Control | Components Incorrectly labeled as either smaller or larger and incorrect side (right/left). |
| Dec 29, 2022 | Class II | Z-1043-2023 | Labeling Change Control | Components Incorrectly labeled as either smaller or larger and incorrect side (right/left). |
| Oct 22, 2018 | Class II | Z-0495-2019 | Labeling mix-ups | Label on the outer carton or the patient labels does not match label on the inner sterile packaging |
| Oct 22, 2018 | Class II | Z-0496-2019 | Labeling mix-ups | Label on the outer carton or the patient labels does not match label on the inner sterile packaging |
| May 24, 2018 | Class II | Z-2289-2018 | Under Investigation by firm | Two lots of tibial bearings were commingled. There is a possibility that a 14mm tibial bearing is packaged in a box labeled as 12 mm tibial bearing and vice versa. This may lead to extension of surgery to find another implant. |
| May 11, 2018 | Class II | Z-2183-2018 | Under Investigation by firm | The label master file was errantly set up as a 63/37mm instead of a 63/67mm. There is no 63/37 size offered, and the product is laser marked with the correct size. |
| Oct 3, 2017 | Class II | Z-1011-2018 | Error in labeling | The affected products are labeled as a 62.5mm LEFT Femur; however, the contents are a Vanguard 70mm RIGHT Femur. |
The 5 latest of 7 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 31 years and passes through 3 companies; a new generation was cleared every 3.7 years on median.
- 13 of the 40 ancestors have a recall of any class.
- Of its descendants, K221479 (Zimmer, Inc., 2022) has gone furthest, with 8 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. 2012, 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 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113550 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113550: Vanguard Complete Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113550
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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