510(k) · Cleared
ClearedVanguard SSK 360 Revision 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 May 16, 2012 as substantially equivalent to K093293 (Biomet, Inc., 2010) after a 30-day review. Its family tree reaches back 4 generations to 1992. 7 later devices descend from it.
- Decided
- May 16, 2012
- Review
- 30 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K915132 (1992). 6 ancestors in all. 7 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK915132 MCK Maximum Congruent Knee) Knee SystemBiomet, Inc. · 1992 · Recalled
- 3 generations backK023546 Maxim Accel Knee SystemBiomet, Inc. · 2003 · Recalled
- 2 generations backK042757 Vanguard SSK Knee SystemBiomet, Inc. · 2005 · Recalled
- 1 generation backK093293 Vanguard 360 Revision Knee SystemBiomet, Inc. · 2010 · Recalled
- This deviceK121149 Vanguard SSK 360 Revision Knee SystemBiomet Manufacturing Corp · 2012
- Descendant · cites it directly · 5 of its ownK171054 Biomet Knee Joint Replacement ProsthesesBiomet, Inc. · 2017 · Recalled
- Descendant · cites it directly · 4 of its ownK181947 Persona Revision Knee SystemZimmer, Inc. · 2018 · Recalled
- Descendant · 2 generations on · 1 of its ownK191625 Persona Revision Knee SystemZimmer, Inc. · 2019 · Recalled
- Descendant · 2 generations on · 0 of its ownK243724 Persona® Revision Knee System (Persona Revision SoluTion™ Femoral…Zimmer, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK210829 Persona Revision Knee System Femoral Metaphyseal ConesZimmer, Inc. · 2021
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K171054Biomet Knee Joint Replacement ProsthesesBiomet, Inc. · 2017 · cites it directly5descendants
- K181947Persona Revision Knee SystemZimmer, Inc. · 2018 · cites it directly4descendants
- K191625Persona Revision Knee SystemZimmer, Inc. · 2019 · 2 generations on1descendant
- K243724Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components)Zimmer, Inc. · 2025 · 2 generations on0descendants
- K210829Persona Revision Knee System Femoral Metaphyseal ConesZimmer, Inc. · 2021 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K915132 | MCK Maximum Congruent Knee) Knee System | Biomet, Inc. | 1992 | 6 |
| −3 | K023546 | Maxim Accel Knee System | Biomet, Inc. | 2003 | 13 |
| −2 | K042757 | Vanguard SSK Knee System | Biomet, Inc. | 2005 | 1 |
| −1 | K093293 | Vanguard 360 Revision Knee System | Biomet, Inc. | 2010 | 5 |
| 0 (this device) | K121149 | Vanguard SSK 360 Revision Knee System | Biomet Manufacturing Corp | 2012 | — |
| +1 | K171054 | Biomet Knee Joint Replacement Prostheses | Biomet, Inc. | 2017 | 4 |
| +1 | K181947 | Persona Revision Knee System | Zimmer, Inc. | 2018 | 1 |
| +2 | K191625 | Persona Revision Knee System | Zimmer, Inc. | 2019 | 1 |
| +2 | K243724 | Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components) | Zimmer, Inc. | 2025 | — |
| +2 | K210829 | Persona Revision Knee System Femoral Metaphyseal Cones | Zimmer, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 2 | 0 |
| 2025 | 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? (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 |
|---|---|---|---|
| * | K093293 | Vanguard 360 Revision Knee SystemSummary page 1…Fax: 574-371-1027 e-mail: 2arv.baker(ibiomnet.com Proprietary Name: Vanguard® S5K 360 Revision Knee System - K093293 Common Name: Knee prosthesis Classification Name(s): Knee joint patellofemorotibial, semi -constrained,… | 2010 |
What descends from it? (7)
3 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 20 years and passes through 2 companies; a new generation was cleared every 5.7 years on median.
- 5 of the 6 ancestors have a recall of any class.
- Of its descendants, K171054 (Biomet, Inc., 2017) has gone furthest, with 5 descendants of its own.
- 5 other devices also cite its predicate K093293.
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. The Regenerexm femoral augments are indicated for use with the Vanguard" Total Knee System. The Regenerex tibial augments…
Read the full statement (115 words)
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.
The Regenerexm femoral augments are indicated for use with the Vanguard" Total Knee System.
The Regenerex tibial augments are indicated for use with standard and offset Biomet® Tibial Trays.
Femoral components and tibial tray components with porous coatings are indicated for cemented and uncemented biological fixation application. Non-coated (InterlokTM) devices and all-polyethylene patellar components are indicated for cemented application only. Regenerex TM components are intended only for uncemented biologic fixation application.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121149 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121149: Vanguard SSK 360 Revision 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/K121149
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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