510(k) · Cleared
ClearedVanguard Complete Knee System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer, Inc. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on May 10, 2019 as substantially equivalent to K023546 (Biomet, Inc., 2003) and 6 other predicates after a 140-day review. Its family tree reaches back 11 generations to 1981. 1 later device descends from it.
- Decided
- May 10, 2019
- Review
- 140 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 11 generations to K810258 (1981). 97 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 11 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 7 generations between
- 3 generations backK120370 Vivacit-E Vitamin E Highly Crosslinked Polyethylene LinersZimmer, Inc. · 2012
- 2 generations backK121771 Zimmer Persona the Personalized Knee SystemZimmer, Inc. · 2012 · Recalled
- 1 generation backK150090 Zimmer Persona Personalized Knee SystemZimmer, Inc. · 2015
- This deviceK183583 Vanguard Complete Knee SystemZimmer, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK253961 SK Knee SystemJust Medical Devices (Tianjin) Co., Ltd. · 2026
Show all 11 generations
- Root · 11 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 10 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
- 9 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
- 8 generations backK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
- 7 generations backK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
- 6 generations backK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
- 5 generations backK073102 Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular LinersBiomet Manufacturing Corp · 2007
- 4 generations backK100048 E1 Antioxidant Infused TechnologyBiomet Manufacturing Corp · 2010
- 3 generations backK120370 Vivacit-E Vitamin E Highly Crosslinked Polyethylene LinersZimmer, Inc. · 2012
- 2 generations backK121771 Zimmer Persona the Personalized Knee SystemZimmer, Inc. · 2012 · Recalled
- 1 generation backK150090 Zimmer Persona Personalized Knee SystemZimmer, Inc. · 2015
- This deviceK183583 Vanguard Complete Knee SystemZimmer, Inc. · 2019
Most influential descendants
Showing 1 of 1 · See all- K253961SK Knee SystemJust Medical Devices (Tianjin) Co., Ltd. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K810258 | Proximal Fermoral Hip Replacement | Biomet, Inc. | 1981 | — |
| −10 | K974558 | Salvage/Onocology Hip and Total Femur System | Biomet, Inc. | 1998 | — |
| −9 | K032396 | Ringloc 36MM Line and Modular Femoral Heads | Biomet, Inc. | 2003 | 3 |
| −8 | K042051 | Arcomxl Polyethylene Liners | Biomet, Inc. | 2005 | 1 |
| −7 | K051411 | Arcomxl Polyethylene Liners and Biolox Delta Heads | Biomet, Inc. | 2005 | 1 |
| −6 | K061312 | 36MM Biolox Delta Ceramic Heads | Biomet, Inc. | 2006 | — |
| −5 | K073102 | Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular Liners | Biomet Manufacturing Corp | 2007 | — |
| −4 | K100048 | E1 Antioxidant Infused Technology | Biomet Manufacturing Corp | 2010 | — |
| −3 | K120370 | Vivacit-E Vitamin E Highly Crosslinked Polyethylene Liners | Zimmer, Inc. | 2012 | — |
| −2 | K121771 | Zimmer Persona the Personalized Knee System | Zimmer, Inc. | 2012 | 2 |
| −1 | K150090 | Zimmer Persona Personalized Knee System | Zimmer, Inc. | 2015 | — |
| 0 (this device) | K183583 | Vanguard Complete Knee System | Zimmer, Inc. | 2019 | — |
| +1 | K253961 | SK Knee System | Just Medical Devices (Tianjin) Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1986 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 4 | 0 |
| 1993 | 2 | 0 |
| 1994 | 6 | 0 |
| 1995 | 10 | 0 |
| 1996 | 5 | 0 |
| 1997 | 4 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 4 | 0 |
| 2001 | 4 | 0 |
| 2002 | 4 | 0 |
| 2003 | 7 | 0 |
| 2004 | 5 | 0 |
| 2005 | 4 | 0 |
| 2006 | 3 | 0 |
| 2007 | 5 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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? (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 4…Design Predicates: x Vanguard® CR Knee System, manufactured by Biomet, K023546, cleared 01/17/2003 x Vanguard® PS+ Knee System, manufactured by… | 2003 |
| * | K041046 | Maxim Accel (Vanguard) PS+ BearingsSummary page 4…met, K023546, cleared 01/17/2003 x Vanguard® PS+ Knee System, manufactured by Biomet, K041046, cleared 05/21/2004 x Vanguard® AS Tibial Bearings, manufactured by… | 2004 |
| * | K050222 | Vanguard Anterior Stabilized Tibial BearingsSummary page 4…, K041046, cleared 05/21/2004 x Vanguard® AS Tibial Bearings, manufactured by Biomet, K050222, cleared 08/16/2005 x E1 Tibial Components (previously E-poly),… | 2005 |
| * | K080528 | E-Poly Tibial BearingsSummary page 4…leared 08/16/2005 x E1 Tibial Components (previously E-poly), manufactured by Biomet, K080528, cleared 06/17/2008 . - 3DJHRI… | 2008 |
| * | K113550 | Vanguard Complete Knee SystemSummary page 5…. - 3DJHRI x Vanguard® Complete Knee System, manufactured by Biomet, K113550, cleared 02/29/2012 Material Predicate: x… | 2012 |
| * | K121771 | Zimmer Persona the Personalized Knee SystemSummary page 5…12 Material Predicate: x Persona® Personalized Knee System, manufactured by Zimmer, K121771, cleared 11/07/2012 x Persona® Personalized Knee System,… | 2012 |
| * | K150090 | Zimmer Persona Personalized Knee SystemSummary page 5…eared 11/07/2012 x Persona® Personalized Knee System, manufactured by Zimmer, K150090, cleared 05/20/2015 Purpose and Device The purpose of this subject 510(k) is to introduce… | 2015 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K253961 | SK Knee System | 2026 | 0 |
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 38 years and passes through 3 companies; a new generation was cleared every 2.2 years on median.
- 42 of the 97 ancestors have a recall of any class.
- Of its descendants, K253961 (Just Medical Devices (Tianjin) Co., Ltd., 2026) has gone furthest, with 0 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. 2019, 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.
Femoral components and tibial tray components with porous coatings are indicated for cemented and un-cemented 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/K183583 · printed Nov 4, 2026
Cite this page
510(k) Report. “K183583: Vanguard Complete Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K183583
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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