510(k) · Cleared
ClearedZimmer Persona the Personalized Knee System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer, Inc. · MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Cleared on Dec 5, 2012 as substantially equivalent to K113369 (Zimmer, Inc., 2012) and 3 other predicates after an 89-day review. Its family tree reaches back 6 generations to 1995. 21 later devices descend from it.
- Decided
- Dec 5, 2012
- Review
- 89 days
- Class
- Class II
- Product code
- MBH
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 6 generations to K933785 (1995). 18 ancestors in all. 21 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK933785 Next Generation Knee SystemZimmer, Inc. · 1995 · Recalled
- 5 generations backK023211 Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral…Zimmer, Inc. · 2002 · Recalled
- 4 generations backK060370 Nexgen Knee Gender Solutions Female (GSF) Femoral ComponentsZimmer, Inc. · 2006 · Recalled
- 3 generations backK070214 Gender Solutions Natural-Knee Flex SystemZimmer, Inc. · 2007 · Recalled
- 2 generations backK073286 Gender Solutions Natural-Knee Flex SystemZimmer, Inc. · 2008 · Recalled
- 1 generation backK113369 Zimmer Persona Knee SystemZimmer, Inc. · 2012 · Recalled
- This deviceK122745 Zimmer Persona the Personalized Knee SystemZimmer, Inc. · 2012
- Descendant · cites it directly · 15 of its ownK172524 Zimmer Persona Personalized Knee SystemZimmer, Inc. · 2018
- Descendant · cites it directly · 8 of its ownK221479 Persona Personalized Knee SystemZimmer, Inc. · 2022
- Descendant · 2 generations on · 6 of its ownK173890 GMK Sphere - Kinematic AlignmentMedacta International S.A. · 2018
- Descendant · 2 generations on · 3 of its ownK240299 Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella)Zimmer, Inc. · 2024
- Descendant · 2 generations on · 3 of its ownK201343 Triathlon Total KneeSystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2020
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K172524Zimmer Persona Personalized Knee SystemZimmer, Inc. · 2018 · cites it directly15descendants
- K221479Persona Personalized Knee SystemZimmer, Inc. · 2022 · cites it directly8descendants
- K173890GMK Sphere - Kinematic AlignmentMedacta International S.A. · 2018 · 2 generations on6descendants
- K240299Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella)Zimmer, Inc. · 2024 · 2 generations on3descendants
- K201343Triathlon Total KneeSystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2020 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K933785 | Next Generation Knee System | Zimmer, Inc. | 1995 | 83 |
| −5 | K023211 | Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral Components | Zimmer, Inc. | 2002 | 6 |
| −4 | K060370 | Nexgen Knee Gender Solutions Female (GSF) Femoral Components | Zimmer, Inc. | 2006 | 17 |
| −3 | K070214 | Gender Solutions Natural-Knee Flex System | Zimmer, Inc. | 2007 | 63 |
| −2 | K073286 | Gender Solutions Natural-Knee Flex System | Zimmer, Inc. | 2008 | 5 |
| −1 | K113369 | Zimmer Persona Knee System | Zimmer, Inc. | 2012 | 39 |
| 0 (this device) | K122745 | Zimmer Persona the Personalized Knee System | Zimmer, Inc. | 2012 | — |
| +1 | K172524 | Zimmer Persona Personalized Knee System | Zimmer, Inc. | 2018 | — |
| +1 | K221479 | Persona Personalized Knee System | Zimmer, Inc. | 2022 | — |
| +2 | K173890 | GMK Sphere - Kinematic Alignment | Medacta International S.A. | 2018 | — |
| +2 | K240299 | Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella) | Zimmer, Inc. | 2024 | — |
| +2 | K201343 | Triathlon Total KneeSystem | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 2 | 0 |
| 2020 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 3 | 0 |
| 2024 | 4 | 0 |
| 2025 | 1 | 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 MBH? 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 MBH device
- #1 K241597 Freedom® Total Knee System - Porous Tibial…score 19.9 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K113369 | Zimmer Persona Knee System | 2012 |
| * | K072160 | Nexgen Trabecular Metal Tibial TraySummary page 1…March 27, 2012) NexGen® TrabecularMetaTM Metal Tibial Tray (K072 160, cleared September 5, 2007) Nex~en® Complete Knee Solution Cruciate Retaining Flex… | 2007 |
| * | K023211 | Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral ComponentsSummary page 1…olution Cruciate Retaining Flex Femoral (CR Flex) Components,,manufactured by Zimmer, Inc. (K02321 1, cleared October 17, 2002) 9 ==… | 2002 |
| * | K072619 | Nexgen Complete Knee Solution LPS-Flex and Knee Gender Solutions Female (GSF) Porous…Summary page 2…Solutions Female (GSF), CR-Flex and LPS-Flex Porous Femoral components, manufactured by Zimmer, Inc. (K0726 19, cleared November 21, 2007 Device Description: The PersonaTM Personalized Knee System is a semi-… | 2007 |
What descends from it? (21)
See all 212 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 17 years and passes through 1 company; a new generation was cleared every 3.5 years on median.
- 15 of the 18 ancestors have a recall of any class.
- Of its descendants, K172524 (Zimmer, Inc., 2018) has gone furthest, with 15 descendants of its own.
- 16 other devices also cite its predicate K113369.
How does its category compare?
All MBH devicesMBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, 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 · MBH
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MBH
98in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MBH
1in 2024
Class I (5 since 2007) Class II/III not classified
Adverse event reports per year · MBH
1,561in 2025
MAUDE reports naming product code MBH, 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 | 10 | 59 | 0 | 27 |
| 2008 | 3 | 70 | 0 | 21 |
| 2009 | 3 | 209 | 2 | 89 |
| 2010 | 4 | 84 | 0 | 121 |
| 2011 | 5 | 84 | 15 | 247 |
| 2012 | 5 | 90 | 1 (1) | 370 |
| 2013 | 6 | 138 | 4 (4) | 308 |
| 2014 | 9 | 114 | 0 | 385 |
| 2015 | 8 | 100 | 0 | 955 |
| 2016 | 4 | 74 | 1 | 1,034 |
| 2017 | 4 | 115 | 9 | 1,007 |
| 2018 | 6 | 89 | 1 | 1,191 |
| 2019 | 1 | — | 1 | 1,394 |
| 2020 | 7 | 112 | 2 | 1,089 |
| 2021 | 6 | 48 | 0 | 1,539 |
| 2022 | 7 | 57 | 0 | 1,261 |
| 2023 | 6 | 94 | 2 | 1,263 |
| 2024 | 10 | 84 | 1 | 1,497 |
| 2025 | 8 | 98 | 0 | 1,561 |
| 2026 | 7 | 153 | 4 | — |
What is it indicated for?
This device is indicated for patients with severe knee pain and disability due to: - Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. - Collagen disorders, and/or avascular necrosis of the femoral condyle. - Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. - Moderate valgus, varus, or flexion deformities. - The salvage of previously failed surgical…
Read the full statement (109 words)
This device is indicated for patients with severe knee pain and disability due to:
- Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
- Collagen disorders, and/or avascular necrosis of the femoral condyle.
- Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.
- Moderate valgus, varus, or flexion deformities.
- The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.
Porous coated components may be used cemented or uncemented (biological fixation). All other femoral, tibial baseplate, and all-polyethylene (UHMWPE and VEXLPE) patella components are indicated for cemented use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122745 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122745: Zimmer Persona the Personalized 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/K122745
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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