510(k) · Cleared
Recalled · Class II · 2017Vanguard SSK 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 Feb 11, 2005 as substantially equivalent to K023546 (Biomet, Inc., 2003) and 1 other predicate after a 130-day review. Its family tree reaches back 2 generations to 1992. 23 later devices descend from it. It has been recalled once.
- Decided
- Feb 11, 2005
- Review
- 130 days
- Class
- Class II
- Product code
- JWH
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K915132 (1992). 3 ancestors in all. 23 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK915132 MCK Maximum Congruent Knee) Knee SystemBiomet, Inc. · 1992 · Recalled
- 1 generation backK023546 Maxim Accel Knee SystemBiomet, Inc. · 2003 · Recalled
- This deviceK042757 Vanguard SSK Knee SystemBiomet, Inc. · 2005
- Descendant · cites it directly · 21 of its ownK093293 Vanguard 360 Revision Knee SystemBiomet, Inc. · 2010 · Recalled
- Descendant · 2 generations on · 10 of its ownK122183 Augment and Screw, Psa TypeUnited Orthopedic Corp. · 2013
- Descendant · 2 generations on · 7 of its ownK121149 Vanguard SSK 360 Revision Knee SystemBiomet Manufacturing Corp · 2012
- Descendant · cites it directly · 6 of its ownK080204 Vanguard Knee System Titanium Femoral ComponentsBiomet, Inc. · 2008
- Descendant · cites it directly · 5 of its ownK171054 Biomet Knee Joint Replacement ProsthesesBiomet, Inc. · 2017 · Recalled
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · See all- K093293Vanguard 360 Revision Knee SystemBiomet, Inc. · 2010 · cites it directly21descendants
- K122183Augment and Screw, Psa TypeUnited Orthopedic Corp. · 2013 · 2 generations on10descendants
- K121149Vanguard SSK 360 Revision Knee SystemBiomet Manufacturing Corp · 2012 · 2 generations on7descendants
- K080204Vanguard Knee System Titanium Femoral ComponentsBiomet, Inc. · 2008 · cites it directly6descendants
- K171054Biomet Knee Joint Replacement ProsthesesBiomet, Inc. · 2017 · cites it directly5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K915132 | MCK Maximum Congruent Knee) Knee System | Biomet, Inc. | 1992 | 6 |
| −1 | K023546 | Maxim Accel Knee System | Biomet, Inc. | 2003 | 13 |
| 0 (this device) | K042757 | Vanguard SSK Knee System | Biomet, Inc. | 2005 | — |
| +1 | K093293 | Vanguard 360 Revision Knee System | Biomet, Inc. | 2010 | 5 |
| +2 | K122183 | Augment and Screw, Psa Type | United Orthopedic Corp. | 2013 | — |
| +2 | K121149 | Vanguard SSK 360 Revision Knee System | Biomet Manufacturing Corp | 2012 | — |
| +1 | K080204 | Vanguard Knee System Titanium Femoral Components | Biomet, Inc. | 2008 | — |
| +1 | K171054 | Biomet Knee Joint Replacement Prostheses | Biomet, Inc. | 2017 | 4 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 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? (2)
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…prosthesis (21 CFR § 888.3560) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Maxim Accel (Vanguard) Knee System - K023546 (Biomet Inc.) Maximum Congruent Knee System - K9151332 (Biomet Inc.) Device Description: The Vanguard TM SSK Knee Syste… | 2003 |
| * | K915132 | MCK Maximum Congruent Knee) Knee System Our reading of the summary gave K915332, FDA’s number for Model 795 Fluorometer/Densitometer (Ciba Corning Diagnostics Corp.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Maximum Congruent Knee System”. | 1992 |
What descends from it? (23)
See all 234 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 17, 2017 | Class II | Z-1861-2017 | Process design | Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 1 company; a new generation was cleared every 10.9 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K093293 (Biomet, Inc., 2010) has gone furthest, with 21 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.
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 joint replacement procedure.
VanguardTM SSK components are intended for cemented use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042757 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042757: Vanguard SSK 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/K042757
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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