510(k) · Cleared
Cleared23 MM Single-Peg Patella Component
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Manufacturing, Inc. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Sep 25, 2006 as substantially equivalent to K040770 (Biomet Manufacturing, Inc., 2004) and 2 other predicates after a 133-day review. Its family tree reaches back 2 generations to 1991. 47 later devices descend from it.
- Decided
- Sep 25, 2006
- Review
- 133 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K912245 (1991). 3 ancestors in all. 47 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK912245 Agc Revision Knee ProthesisBiomet, Inc. · 1991 · Recalled
- 1 generation backK040770 Vanguard Patella ComponentsBiomet Manufacturing, Inc. · 2004 · Recalled
- This deviceK061340 23 MM Single-Peg Patella ComponentBiomet Manufacturing, Inc. · 2006
- Descendant · cites it directly · 46 of its ownK113550 Vanguard Complete Knee SystemBiomet Manufacturing Corp · 2012 · Recalled
- Descendant · 2 generations on · 8 of its ownK221479 Persona Personalized Knee SystemZimmer, Inc. · 2022
- Descendant · 2 generations on · 8 of its ownK151266 Physica CR Knee SystemLima Corporate S.P.A. · 2015
- Descendant · 2 generations on · 7 of its ownK152008 Physica PS Knee SystemLima Corporate S.P.A. · 2015
- Descendant · 2 generations on · 6 of its ownK193284 Physica LMC Knee SystemLima Corporate S.P.A. · 2020
Showing 5 of 47 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 47 · See all- K113550Vanguard Complete Knee SystemBiomet Manufacturing Corp · 2012 · cites it directly46descendants
- K221479Persona Personalized Knee SystemZimmer, Inc. · 2022 · 2 generations on8descendants
- K151266Physica CR Knee SystemLima Corporate S.P.A. · 2015 · 2 generations on8descendants
- K152008Physica PS Knee SystemLima Corporate S.P.A. · 2015 · 2 generations on7descendants
- K193284Physica LMC Knee SystemLima Corporate S.P.A. · 2020 · 2 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K912245 | Agc Revision Knee Prothesis | Biomet, Inc. | 1991 | 3 |
| −1 | K040770 | Vanguard Patella Components | Biomet Manufacturing, Inc. | 2004 | 13 |
| 0 (this device) | K061340 | 23 MM Single-Peg Patella Component | Biomet Manufacturing, Inc. | 2006 | — |
| +1 | K113550 | Vanguard Complete Knee System | Biomet Manufacturing Corp | 2012 | 7 |
| +2 | K221479 | Persona Personalized Knee System | Zimmer, Inc. | 2022 | — |
| +2 | K151266 | Physica CR Knee System | Lima Corporate S.P.A. | 2015 | — |
| +2 | K152008 | Physica PS Knee System | Lima Corporate S.P.A. | 2015 | — |
| +2 | K193284 | Physica LMC Knee System | Lima Corporate S.P.A. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K040770 | Vanguard Patella ComponentsSummary page 1…emi-constrained cemented prosthesis (21 CFR 888.3560) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: 1. Vanguard' TM Patella (K040770) 2. Ultra High Molecular Weight Components Knees (K921182) 3. AGC Revision Knee Prosthesis (K912245) Device Description: The 23… | 2004 |
| * | K921182 | Ultra High Molecular Weight Polyethylene ComponentSummary page 1…21 CFR 888.3560) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: 1. Vanguard' TM Patella (K040770) 2. Ultra High Molecular Weight Components Knees (K921182) 3. AGC Revision Knee Prosthesis (K912245) Device Description: The 23 mm Single-Peg Patella Component has the following features… | 1993 |
| * | K912245 | Agc Revision Knee ProthesisSummary page 1…To Which Substantial Equivalence Is Claimed: 1. Vanguard' TM Patella (K040770) 2. Ultra High Molecular Weight Components Knees (K921182) 3. AGC Revision Knee Prosthesis (K912245) Device Description: The 23 mm Single-Peg Patella Component has the following features: (1) 23 mm diameter with a I" true dome s… | 1991 |
What descends from it? (47)
See all 471 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K113550 | Vanguard Complete Knee System | 2012 | 46 |
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 15 years and passes through 2 companies; a new generation was cleared every 12.7 years on median.
- 3 of the 3 ancestors have a recall of any class.
- Of its descendants, K113550 (Biomet Manufacturing Corp, 2012) has gone furthest, with 46 descendants of its own.
- 7 other devices also cite its predicate K040770.
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?
The 23 mm Single Peg Patella Components intended use is for replacement of part of the knee joint in conjunction with a femoral and tibial component. Specifically:
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.
The device is indicated for cemented application only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061340 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061340: 23 MM Single-Peg Patella Component.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061340
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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