510(k) · Cleared
Recalled · Class II · 2016Zimmer 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 Nov 7, 2012 as substantially equivalent to K113369 (Zimmer, Inc., 2012) and 4 other predicates after a 145-day review. Its family tree reaches back 9 generations to 1981. 59 later devices descend from it. It has been recalled 2 times.
- Decided
- Nov 7, 2012
- Review
- 145 days
- Class
- Class II
- Product code
- MBH
- Recalls
- 2
- Predicates
- 5
Its longest line of descent runs back 9 generations to K810258 (1981). 75 ancestors in all. 59 later devices descend from it, 9 citing it directly.
- Root · 9 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 5 generations between
- 3 generations backK073102 Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular LinersBiomet Manufacturing Corp · 2007
- 2 generations backK100048 E1 Antioxidant Infused TechnologyBiomet Manufacturing Corp · 2010
- 1 generation backK120370 Vivacit-E Vitamin E Highly Crosslinked Polyethylene LinersZimmer, Inc. · 2012
- This deviceK121771 Zimmer Persona the Personalized Knee SystemZimmer, Inc. · 2012
- Descendant · cites it directly · 17 of its ownK150090 Zimmer Persona Personalized Knee SystemZimmer, Inc. · 2015
- Descendant · cites it directly · 15 of its ownK172524 Zimmer Persona Personalized Knee SystemZimmer, Inc. · 2018
- Descendant · cites it directly · 15 of its ownK141635 Arthrex Ibalance Tka SystemArthrex, Inc. · 2014
- Descendant · 2 generations on · 10 of its ownK151256 Arthrex BioSync® Bone WedgeArthex, Inc. · 2015 · Recalled
- Descendant · cites it directly · 9 of its ownK173417 Zimmer Persona Personalized Knee SystemZimmer, Inc. · 2018
Show all 9 generations
- Root · 9 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 8 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
- 7 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
- 6 generations backK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
- 5 generations backK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
- 4 generations backK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
- 3 generations backK073102 Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular LinersBiomet Manufacturing Corp · 2007
- 2 generations backK100048 E1 Antioxidant Infused TechnologyBiomet Manufacturing Corp · 2010
- 1 generation backK120370 Vivacit-E Vitamin E Highly Crosslinked Polyethylene LinersZimmer, Inc. · 2012
- This deviceK121771 Zimmer Persona the Personalized Knee SystemZimmer, Inc. · 2012
Showing 5 of 59 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 59 · See all- K150090Zimmer Persona Personalized Knee SystemZimmer, Inc. · 2015 · cites it directly17descendants
- K172524Zimmer Persona Personalized Knee SystemZimmer, Inc. · 2018 · cites it directly15descendants
- K141635Arthrex Ibalance Tka SystemArthrex, Inc. · 2014 · cites it directly15descendants
- K151256Arthrex BioSync® Bone WedgeArthex, Inc. · 2015 · 2 generations on10descendants
- K173417Zimmer Persona Personalized Knee SystemZimmer, Inc. · 2018 · cites it directly9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K810258 | Proximal Fermoral Hip Replacement | Biomet, Inc. | 1981 | — |
| −8 | K974558 | Salvage/Onocology Hip and Total Femur System | Biomet, Inc. | 1998 | — |
| −7 | K032396 | Ringloc 36MM Line and Modular Femoral Heads | Biomet, Inc. | 2003 | 3 |
| −6 | K042051 | Arcomxl Polyethylene Liners | Biomet, Inc. | 2005 | 1 |
| −5 | K051411 | Arcomxl Polyethylene Liners and Biolox Delta Heads | Biomet, Inc. | 2005 | 1 |
| −4 | K061312 | 36MM Biolox Delta Ceramic Heads | Biomet, Inc. | 2006 | — |
| −3 | K073102 | Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular Liners | Biomet Manufacturing Corp | 2007 | — |
| −2 | K100048 | E1 Antioxidant Infused Technology | Biomet Manufacturing Corp | 2010 | — |
| −1 | K120370 | Vivacit-E Vitamin E Highly Crosslinked Polyethylene Liners | Zimmer, Inc. | 2012 | — |
| 0 (this device) | K121771 | Zimmer Persona the Personalized Knee System | Zimmer, Inc. | 2012 | — |
| +1 | K150090 | Zimmer Persona Personalized Knee System | Zimmer, Inc. | 2015 | — |
| +1 | K172524 | Zimmer Persona Personalized Knee System | Zimmer, Inc. | 2018 | — |
| +1 | K141635 | Arthrex Ibalance Tka System | Arthrex, Inc. | 2014 | — |
| +2 | K151256 | Arthrex BioSync® Bone Wedge | Arthex, Inc. | 2015 | 6 |
| +1 | K173417 | Zimmer Persona Personalized Knee System | Zimmer, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1992 | 4 | 0 |
| 1993 | 1 | 0 |
| 1994 | 6 | 0 |
| 1995 | 8 | 0 |
| 1996 | 3 | 0 |
| 1997 | 3 | 0 |
| 1999 | 2 | 0 |
| 2000 | 3 | 0 |
| 2001 | 4 | 0 |
| 2002 | 4 | 0 |
| 2003 | 4 | 0 |
| 2004 | 3 | 0 |
| 2005 | 4 | 0 |
| 2006 | 1 | 0 |
| 2007 | 5 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2018 | 4 | 0 |
| 2019 | 4 | 0 |
| 2020 | 6 | 0 |
| 2021 | 6 | 0 |
| 2022 | 5 | 0 |
| 2023 | 5 | 0 |
| 2024 | 10 | 0 |
| 2025 | 7 | 0 |
| 2026 | 8 | 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? (5)
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 SystemSummary page 1…ibial polymer/metal/polymer semi-constrained cemented Predicate Device: PersonaTM Personalized Knee System (K 113369, cleared March 27, 2012) NexGen® TrabecularMetal… | 2012 |
| * | K072160 | Nexgen Trabecular Metal Tibial TraySummary page 1…e System (K 113369, cleared March 27, 2012) NexGen® TrabecularMetalTM Metal Tibial Tray (K072 160, cleared September 5, 2007) Vivacit-ht Vitamin E… | 2007 |
| * | K120370 | Vivacit-E Vitamin E Highly Crosslinked Polyethylene LinersSummary page 1…Vivacit-ht Vitamin E Highly Crosslinked Polyethylene Liners, manufactured by Zimmer, Inc. (K120370, cleared June 4, 2012) ElTm Antioxidant Infused… | 2012 |
| * | K100048 | E1 Antioxidant Infused TechnologySummary page 1…2012) ElTm Antioxidant Infused Technology, Manufactured by Biomet Manufacturing Corp. (K]100048, cleared March 9, 2010) DePuy Attune Knee System… | 2010 |
| * | K101433 | Depuy Attune Knee SystemSummary page 1…2010) DePuy Attune Knee System, manufactured by DePuy Orthopaedics, Inc. (K101433, cleared December 10, 2010) Page 1 of 4 Device Description:… | 2010 |
What descends from it? (59)
See all 599 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150090 | Zimmer Persona Personalized Knee System | 2015 | 17 |
| K172524 | Zimmer Persona Personalized Knee System | 2018 | 15 |
| K141635 | Arthrex Ibalance Tka System | 2014 | 15 |
| K173417 | Zimmer Persona Personalized Knee System | 2018 | 9 |
| K123459 | Zimmer Persona TM Personalized Knee System | 2013 | 9 |
| K181947 | Persona Revision Knee System | 2018 | 4 |
| K222566 | Zimmer Persona Personalized Knee System | 2022 | 2 |
| K183583 | Vanguard Complete Knee System | 2019 | 1 |
| K190068 | Vanguard XP Knee System | 2019 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 11, 2016 | Class II | Z-1917-2016 | Component design/selection | Zimmer Inc. is initiating a recall of specific Persona" Trabecular Metal" Tibial Plate Instruments and Modular Brackets, due to incidents of radiolucent lines and loosening in implants. |
| Jan 28, 2015 | Class II | Z-1266-2015 | Under Investigation by firm | An increase in complaints of loosening and radiolucent lines. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 31 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- 34 of the 75 ancestors have a recall of any class.
- Of its descendants, K150090 (Zimmer, Inc., 2015) has gone furthest, with 17 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 (111 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 tibial baseplate components may be used cemented or uncemented (biological fixation). All other femoral, tibial baseplates 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/K121771 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121771: 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/K121771
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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