510(k) · Cleared
ClearedPersona Personalized Knee System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer, Inc. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Nov 17, 2022 as substantially equivalent to K113369 (Zimmer, Inc., 2012) and 5 other predicates after a 178-day review. Its family tree reaches back 11 generations to 1981. 8 later devices descend from it.
- Decided
- Nov 17, 2022
- Review
- 178 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 11 generations to K810258 (1981). 157 ancestors in all. 8 later devices descend from it, 5 citing it directly.
- Root · 11 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 7 generations between
- 3 generations backK093549 44MM E1 Acetabular Liner with 44MM Biolox Delta Option Ceramic Head…Biomet Manufacturing Corp · 2009
- 2 generations backK121874 G7 Acetabular SystemBiomet Manufacturing Corp · 2012 · Recalled
- 1 generation backK140669 G7 Osseoti Acetublar ShellsBiomet, Inc. · 2014
- This deviceK221479 Persona Personalized Knee SystemZimmer, Inc. · 2022
- Descendant · cites it directly · 3 of its ownK240299 Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella)Zimmer, Inc. · 2024
- Descendant · 2 generations on · 1 of its ownK243293 Zimmer® Persona® Personalized Knee SystemZimmer Biomet · 2024
- Descendant · cites it directly · 0 of its ownK251840 Zimmer® Persona® Personalized Knee SystemZimmer, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK253189 Persona the Personalized Knee System (Persona Porous Plasma Spray…Zimmer, Inc. · 2026
- Descendant · 3 generations on · 0 of its ownK253637 Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2026
Show all 11 generations
- Root · 11 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 10 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
- 9 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
- 8 generations backK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
- 7 generations backK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
- 6 generations backK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
- 5 generations backK073102 Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular LinersBiomet Manufacturing Corp · 2007
- 4 generations backK082996 Biolox Delta Option Ceramic HeadsBiomet, Inc. · 2009 · Recalled
- 3 generations backK093549 44MM E1 Acetabular Liner with 44MM Biolox Delta Option Ceramic Head…Biomet Manufacturing Corp · 2009
- 2 generations backK121874 G7 Acetabular SystemBiomet Manufacturing Corp · 2012 · Recalled
- 1 generation backK140669 G7 Osseoti Acetublar ShellsBiomet, Inc. · 2014
- This deviceK221479 Persona Personalized Knee SystemZimmer, Inc. · 2022
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K240299Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella)Zimmer, Inc. · 2024 · cites it directly3descendants
- K243293Zimmer® Persona® Personalized Knee SystemZimmer Biomet · 2024 · 2 generations on1descendant
- K251840Zimmer® Persona® Personalized Knee SystemZimmer, Inc. · 2026 · cites it directly0descendants
- K253189Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)Zimmer, Inc. · 2026 · cites it directly0descendants
- K253637Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing InsertHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K810258 | Proximal Fermoral Hip Replacement | Biomet, Inc. | 1981 | — |
| −10 | K974558 | Salvage/Onocology Hip and Total Femur System | Biomet, Inc. | 1998 | — |
| −9 | K032396 | Ringloc 36MM Line and Modular Femoral Heads | Biomet, Inc. | 2003 | 3 |
| −8 | K042051 | Arcomxl Polyethylene Liners | Biomet, Inc. | 2005 | 1 |
| −7 | K051411 | Arcomxl Polyethylene Liners and Biolox Delta Heads | Biomet, Inc. | 2005 | 1 |
| −6 | K061312 | 36MM Biolox Delta Ceramic Heads | Biomet, Inc. | 2006 | — |
| −5 | K073102 | Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular Liners | Biomet Manufacturing Corp | 2007 | — |
| −4 | K082996 | Biolox Delta Option Ceramic Heads | Biomet, Inc. | 2009 | 4 |
| −3 | K093549 | 44MM E1 Acetabular Liner with 44MM Biolox Delta Option Ceramic Head or 44MM M… | Biomet Manufacturing Corp | 2009 | — |
| −2 | K121874 | G7 Acetabular System | Biomet Manufacturing Corp | 2012 | 3 |
| −1 | K140669 | G7 Osseoti Acetublar Shells | Biomet, Inc. | 2014 | — |
| 0 (this device) | K221479 | Persona Personalized Knee System | Zimmer, Inc. | 2022 | — |
| +1 | K240299 | Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella) | Zimmer, Inc. | 2024 | — |
| +2 | K243293 | Zimmer® Persona® Personalized Knee System | Zimmer Biomet | 2024 | — |
| +1 | K251840 | Zimmer® Persona® Personalized Knee System | Zimmer, Inc. | 2026 | — |
| +1 | K253189 | Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs) | Zimmer, Inc. | 2026 | — |
| +3 | K253637 | Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing… | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 3 | 0 |
| 1989 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 4 | 0 |
| 1993 | 4 | 0 |
| 1994 | 15 | 0 |
| 1995 | 11 | 0 |
| 1996 | 10 | 0 |
| 1997 | 7 | 0 |
| 1998 | 2 | 0 |
| 1999 | 7 | 0 |
| 2000 | 9 | 0 |
| 2001 | 7 | 0 |
| 2002 | 5 | 0 |
| 2003 | 11 | 0 |
| 2004 | 7 | 0 |
| 2005 | 7 | 0 |
| 2006 | 3 | 0 |
| 2007 | 8 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2010 | 6 | 0 |
| 2011 | 1 | 0 |
| 2012 | 6 | 0 |
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 4 | 0 |
| 2026 | 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 K221404 Identity Imprint Knee Replacement System…score 22.3 · 23 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (6)
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 4…ellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis (21 CFR 888.3560) Predicate Device(s): K113369 Zimmer® Zimmer, Inc. Persona™ Knee… | 2012 |
| * | K122745 | Zimmer Persona the Personalized Knee SystemSummary page 4…113369 Zimmer® Zimmer, Inc. Persona™ Knee System K122745 Zimmer® Zimmer, Inc. Persona™ Knee… | 2012 |
| * | K173417 | Zimmer Persona Personalized Knee SystemSummary page 4…122745 Zimmer® Zimmer, Inc. Persona™ Knee System K173417 Zimmer® Zimmer, Inc. Persona™ Knee… | 2018 |
| * | K113550 | Vanguard Complete Knee SystemSummary page 4…173417 Zimmer® Zimmer, Inc. Persona™ Knee System K113550 Vanguard Biomet, Inc. Complete Knee… | 2012 |
| * | K140669 | G7 Osseoti Acetublar ShellsSummary page 4…113550 Vanguard Biomet, Inc. Complete Knee System K140669 G7 OsseoTiTM Biomet, Inc. Acetabular Shells K936159… | 2014 |
| * | K936159 | Natural-Knee II SystemSummary page 4…System K140669 G7 OsseoTiTM Biomet, Inc. Acetabular Shells K936159 Natural Knee II Zimmer, Inc. System… | 1995 |
What descends from it? (8)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K240299 | Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella) | 2024 | 3 |
| K251840 | Zimmer® Persona® Personalized Knee System | 2026 | 0 |
| K253189 | Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs) | 2026 | 0 |
| K242543 | Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs) | 2024 | 0 |
| K230321 | Persona™ Personalized Knee System | 2023 | 0 |
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 41 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- 56 of the 157 ancestors have a recall of any class.
- Of its descendants, K240299 (Zimmer, Inc., 2024) has gone furthest, with 3 descendants of its own.
- 16 other devices also cite its predicate K113369.
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. 2022, 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?
When a mechanical alignment approach is utilized, 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…
Read the full statement (219 words)
When a mechanical alignment approach is utilized, 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.
When a kinematic alignment approach is utilized, 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.
• Moderate valgus, varus, or flexion deformities.
The kinematic alignment (KA) surgical technique may only be used with Persona porous and cemented non-porous CR femoral components, Persona CR or UC articular surface components, and the cemented nonporous Persona Natural cemented 5 degree tibial components without a stem extension,
Porous coated components may be used cemented or uncemented (biological fixation), except for the Persona porous 0 degree OsseoTi Spiked Keel Tibia which is for uncemented use only. All other femoral, tibial baseplate and all-polyethylene (UHMWPE and VEHXPE) patella components are indicated for cemented use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221479 · printed Nov 5, 2026
Cite this page
510(k) Report. “K221479: Persona Personalized Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K221479
Report an extraction error
Are you the manufacturer?
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