510(k) · Cleared
Recalled · Class II · 2020Vanguard 360 Revision Knee System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet, Inc. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Oct 22, 2010 as substantially equivalent to K042757 (Biomet, Inc., 2005) and 2 other predicates after a 366-day review. Its family tree reaches back 3 generations to 1992. 21 later devices descend from it. It has been recalled 5 times.
- Decided
- Oct 22, 2010
- Review
- 366 days
- Class
- Class II
- Product code
- JWH
- Recalls
- 5
- Predicates
- 3
Its longest line of descent runs back 3 generations to K915132 (1992). 5 ancestors in all. 21 later devices descend from it, 6 citing it directly.
- Root · 3 generations backK915132 MCK Maximum Congruent Knee) Knee SystemBiomet, Inc. · 1992 · Recalled
- 2 generations backK023546 Maxim Accel Knee SystemBiomet, Inc. · 2003 · Recalled
- 1 generation backK042757 Vanguard SSK Knee SystemBiomet, Inc. · 2005 · Recalled
- This deviceK093293 Vanguard 360 Revision Knee SystemBiomet, Inc. · 2010
- Descendant · cites it directly · 10 of its ownK122183 Augment and Screw, Psa TypeUnited Orthopedic Corp. · 2013
- Descendant · cites it directly · 7 of its ownK121149 Vanguard SSK 360 Revision Knee SystemBiomet Manufacturing Corp · 2012
- Descendant · 2 generations on · 5 of its ownK171054 Biomet Knee Joint Replacement ProsthesesBiomet, Inc. · 2017 · Recalled
- Descendant · 2 generations on · 5 of its ownK131864 U2 Tibial Baseplate- Cma Type, Tibial Insert and AugmentUnited Orthopedic Corporation · 2014
- Descendant · cites it directly · 4 of its ownK181947 Persona Revision Knee SystemZimmer, Inc. · 2018 · Recalled
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K122183Augment and Screw, Psa TypeUnited Orthopedic Corp. · 2013 · cites it directly10descendants
- K121149Vanguard SSK 360 Revision Knee SystemBiomet Manufacturing Corp · 2012 · cites it directly7descendants
- K171054Biomet Knee Joint Replacement ProsthesesBiomet, Inc. · 2017 · 2 generations on5descendants
- K131864U2 Tibial Baseplate- Cma Type, Tibial Insert and AugmentUnited Orthopedic Corporation · 2014 · 2 generations on5descendants
- K181947Persona Revision Knee SystemZimmer, Inc. · 2018 · cites it directly4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K915132 | MCK Maximum Congruent Knee) Knee System | Biomet, Inc. | 1992 | 6 |
| −2 | K023546 | Maxim Accel Knee System | Biomet, Inc. | 2003 | 13 |
| −1 | K042757 | Vanguard SSK Knee System | Biomet, Inc. | 2005 | 1 |
| 0 (this device) | K093293 | Vanguard 360 Revision Knee System | Biomet, Inc. | 2010 | — |
| +1 | K122183 | Augment and Screw, Psa Type | United Orthopedic Corp. | 2013 | — |
| +1 | K121149 | Vanguard SSK 360 Revision Knee System | Biomet Manufacturing Corp | 2012 | — |
| +2 | K171054 | Biomet Knee Joint Replacement Prostheses | Biomet, Inc. | 2017 | 4 |
| +2 | K131864 | U2 Tibial Baseplate- Cma Type, Tibial Insert and Augment | United Orthopedic Corporation | 2014 | — |
| +1 | K181947 | Persona Revision Knee System | Zimmer, Inc. | 2018 | 1 |
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 |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2021 | 4 | 0 |
| 2022 | 1 | 0 |
| 2025 | 3 | 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? (3)
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 |
|---|---|---|---|
| * | K042757 | Vanguard SSK Knee SystemSummary page 1…prosthesis (21 CFR §888.3560) Product Codes: .TWH, MBV Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Vanguard TM SSK Knee System K042757 Biomet Offset Tibial Tray K010212 Biomet MCK [Maxim®g] Knee System K915 132 Biomet Device… | 2005 |
| * | K010212 | Offset Tibial TraySummary page 1….TWH, MBV Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Vanguard TM SSK Knee System K042757 Biomet Offset Tibial Tray K010212 Biomet MCK [Maxim®g] Knee System K915 132 Biomet Device Description: The Vanguard Tm 360 Revision Knee System… | 2001 |
| * | K915132 | MCK Maximum Congruent Knee) Knee SystemSummary page 1…tial Equivalence Is Claimed: Vanguard TM SSK Knee System K042757 Biomet Offset Tibial Tray K010212 Biomet MCK [Maxim®g] Knee System K915 132 Biomet Device Description: The Vanguard Tm 360 Revision Knee System is a series of femoral, tibial and offset adapter compo… | 1992 |
What descends from it? (21)
See all 216 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K122183 | Augment and Screw, Psa Type | 2013 | 10 |
| K121149 | Vanguard SSK 360 Revision Knee System | 2012 | 7 |
| K181947 | Persona Revision Knee System | 2018 | 4 |
| K143192 | Vanguard 360 Revision Knee System | 2015 | 0 |
| K140883 | Vanguard 360 Osseoti Tibial Sleeve Augment | 2014 | 0 |
| K131116 | U2 Total Knee System - Psa Type, Offset Stem Adapter | 2013 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 1, 2020 | Class II | Z-0723-2021 | Process control | Incorrect bolt -tibial bolts in package instead of femoral bolts may delay procedure |
| Aug 2, 2018 | Class II | Z-3249-2018 | Under Investigation by firm | The implant only has one bolt in the sterile package but it should have had two. |
| Aug 2, 2018 | Class II | Z-3250-2018 | Under Investigation by firm | The implant only has one bolt in the sterile package but it should have had two. |
| Aug 8, 2016 | Class II | Z-0003-2017 | Process control | The drill bit used to drill the hex pre-drilled hole in the screw head of the Tibial Augment Bolts included in the Vanguard 360 Revision Knee System was larger than allowable per the process specification. As a result, the hex geometry… |
| Jul 1, 2014 | Class II | Z-2242-2014 | Process change control | The Vanguard 360 Femoral Boss Reamers were manufactured oversized to the print. The instrument may not fit into the mating component. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 1 company; a new generation was cleared every 5.7 years on median.
- 4 of the 5 ancestors have a recall of any class.
- Of its descendants, K122183 (United Orthopedic Corp., 2013) has gone furthest, with 10 descendants of its own.
- 3 other devices also cite its predicate K042757.
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. 2010, 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?
The indications for the Vanguard 360 Revision Knee System are as follows:
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.
These devices are single-use implants intended for cemented use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093293 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093293: Vanguard 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/K093293
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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