510(k) · Cleared
Recalled · Class II · 2017Zimmer Persona 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 Mar 27, 2012 as substantially equivalent to K936159 (Intermedics Orthopedics, 1995) and 7 other predicates after a 133-day review. Its family tree reaches back 5 generations to 1995. 96 later devices descend from it. It has been recalled 39 times.
- Decided
- Mar 27, 2012
- Review
- 133 days
- Class
- Class II
- Product code
- JWH
- Recalls
- 39
- Predicates
- 8
Its longest line of descent runs back 5 generations to K933785 (1995). 14 ancestors in all. 96 later devices descend from it, 17 citing it directly.
- Root · 5 generations backK933785 Next Generation Knee SystemZimmer, Inc. · 1995 · Recalled
- 4 generations backK023211 Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral…Zimmer, Inc. · 2002 · Recalled
- 3 generations backK060370 Nexgen Knee Gender Solutions Female (GSF) Femoral ComponentsZimmer, Inc. · 2006 · Recalled
- 2 generations backK070214 Gender Solutions Natural-Knee Flex SystemZimmer, Inc. · 2007 · Recalled
- 1 generation backK073286 Gender Solutions Natural-Knee Flex SystemZimmer, Inc. · 2008 · Recalled
- This deviceK113369 Zimmer Persona Knee SystemZimmer, Inc. · 2012
- Descendant · cites it directly · 59 of its ownK121771 Zimmer Persona the Personalized Knee SystemZimmer, Inc. · 2012 · Recalled
- Descendant · cites it directly · 26 of its ownK140833 Itotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc. · 2014
- Descendant · cites it directly · 25 of its ownK122765 Persona Natural Tibia BaseplatesZimmer, Inc. · 2012 · Recalled
- Descendant · 2 generations on · 24 of its ownK142404 iTotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc. · 2014 · Recalled
- Descendant · 2 generations on · 24 of its ownK142161 Itotal Cruciate Retaining (CR) Knee Replacement System, Itotal…Conformis, Inc. · 2014 · Recalled
Showing 5 of 96 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 96 · See all- K121771Zimmer Persona the Personalized Knee SystemZimmer, Inc. · 2012 · cites it directly59descendants
- K140833Itotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc. · 2014 · cites it directly26descendants
- K122765Persona Natural Tibia BaseplatesZimmer, Inc. · 2012 · cites it directly25descendants
- K142404iTotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc. · 2014 · 2 generations on24descendants
- K142161Itotal Cruciate Retaining (CR) Knee Replacement System, Itotal Posterior Stabilized (PS)…Conformis, Inc. · 2014 · 2 generations on24descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K933785 | Next Generation Knee System | Zimmer, Inc. | 1995 | 83 |
| −4 | K023211 | Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral Components | Zimmer, Inc. | 2002 | 6 |
| −3 | K060370 | Nexgen Knee Gender Solutions Female (GSF) Femoral Components | Zimmer, Inc. | 2006 | 17 |
| −2 | K070214 | Gender Solutions Natural-Knee Flex System | Zimmer, Inc. | 2007 | 63 |
| −1 | K073286 | Gender Solutions Natural-Knee Flex System | Zimmer, Inc. | 2008 | 5 |
| 0 (this device) | K113369 | Zimmer Persona Knee System | Zimmer, Inc. | 2012 | — |
| +1 | K121771 | Zimmer Persona the Personalized Knee System | Zimmer, Inc. | 2012 | 2 |
| +1 | K140833 | Itotal Posterior Stabilized (PS) Knee Replacement System | Conformis, Inc. | 2014 | — |
| +1 | K122765 | Persona Natural Tibia Baseplates | Zimmer, Inc. | 2012 | 2 |
| +2 | K142404 | iTotal Posterior Stabilized (PS) Knee Replacement System | Conformis, Inc. | 2014 | 2 |
| +2 | K142161 | Itotal Cruciate Retaining (CR) Knee Replacement System, Itotal Posterior… | Conformis, Inc. | 2014 | 6 |
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 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 3 | 0 |
| 2013 | 3 | 0 |
| 2014 | 6 | 0 |
| 2015 | 4 | 0 |
| 2016 | 6 | 0 |
| 2017 | 1 | 0 |
| 2018 | 5 | 0 |
| 2019 | 5 | 0 |
| 2020 | 10 | 0 |
| 2021 | 12 | 0 |
| 2022 | 7 | 0 |
| 2023 | 8 | 0 |
| 2024 | 10 | 0 |
| 2025 | 7 | 0 |
| 2026 | 9 | 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? (8)
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 |
|---|---|---|---|
| * | K936159 | Natural-Knee II SystemSummary page 1…etallpolymer semi-constrained cemented Predicate Device: NaturalKnee H System, manufactured by Zimmer, Inc. (K936159, cleared May 22, 1995) Gender Solutions~m NaturalKnee® Flex System,… | 1995 |
| * | K070214 | Gender Solutions Natural-Knee Flex SystemSummary page 1…d May 22, 1995) Gender Solutions~m NaturalKnee® Flex System, manufactured by Zimmer, Inc. (K0702 14, cleared March 16, 2007 and K073286, cleared March 7,… | 2007 |
| * | K073286 | Gender Solutions Natural-Knee Flex SystemSummary page 1…aturalKnee® Flex System, manufactured by Zimmer, Inc. (K0702 14, cleared March 16, 2007 and K073286, cleared March 7, 2008) NextGen Complete Knee Syst… | 2008 |
| * | K933785 | Next Generation Knee SystemSummary page 1…2008) NextGen Complete Knee System, manufactured by Zimmer, Inc. (K933785, cleared January 30,.1995) NexGen Complete Knee Solution Legacy Posterior… | 1995 |
| * | K960279 | Nexgen Compl. Knee Sol. Legacy Posterior Stabilized/Constrained Condylar Knee Femoral…Summary page 1…osterior Stabilized (PS) and Constrained Condylar Knee (CCK), manufactured by Zimmer, Inc. (K960279, cleared April 26, 1996) NexGen® Complete Knee Solu… | 1996 |
| * | K991581 | Nexgen Complete Knee Solution Legacy Posterior Stabilized (LPS); LPS-Flex Fixed Bearing…Summary page 1…Elex Fixed Bearing Femoral and Articular Surface Components, manufactured by Zinmmer, Inc. (K99158 1, cleared July 30, 1999) _?rqZ 7t Ll31 Pa… | 1999 |
| * | K023211 | Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral ComponentsSummary page 2…Knee Solution Cruciate Retaining Flex Femoral (CR Flex) Components, manufactured by Zimmer, Inc. (K02321 1,cleared October 17, 2002) NexGen® Knee Gender Solutions Female (GSF)… | 2002 |
| * | K060370 | Nexgen Knee Gender Solutions Female (GSF) Femoral ComponentsSummary page 2…NexGen® Knee Gender Solutions Female (GSF) Femoral Components, manufactured by Zimmer, Inc. (K060370, cleared April 28, 2006) Device Description: The Zimmer&®esn TM Personalized Knee… | 2006 |
What descends from it? (96)
See all 9617 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K121771 | Zimmer Persona the Personalized Knee System | 2012 | 59 |
| K140833 | Itotal Posterior Stabilized (PS) Knee Replacement System | 2014 | 26 |
| K122765 | Persona Natural Tibia Baseplates | 2012 | 25 |
| K130143 | Persona Natural Tibia Baseplates | 2013 | 21 |
| K122745 | Zimmer Persona the Personalized Knee System | 2012 | 21 |
| K142787 | Zimmer Persona Personalized Knee System | 2014 | 16 |
| K172524 | Zimmer Persona Personalized Knee System | 2018 | 15 |
| K123459 | Zimmer Persona TM Personalized Knee System | 2013 | 9 |
| K221479 | Persona Personalized Knee System | 2022 | 8 |
| K133737 | Zimmer (R) Persona the Personalized Kee System 14X +30MM Tapered Stem Extension | 2014 | 5 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 7, 2017 | Class II | Z-1806-2018 | Under Investigation by firm | There is a potential for intermittent cracks in the raw material batch used to produce the affected products. The cleanliness of the affected products could be compromised if cracks penetrate the surface of the instrument as a result of… |
| Aug 7, 2017 | Class II | Z-1808-2018 | Under Investigation by firm | There is a potential for intermittent cracks in the raw material batch used to produce the affected products. The cleanliness of the affected products could be compromised if cracks penetrate the surface of the instrument as a result of… |
| Aug 7, 2017 | Class II | Z-1805-2018 | Under Investigation by firm | There is a potential for intermittent cracks in the raw material batch used to produce the affected products. The cleanliness of the affected products could be compromised if cracks penetrate the surface of the instrument as a result of… |
| Aug 7, 2017 | Class II | Z-1807-2018 | Under Investigation by firm | There is a potential for intermittent cracks in the raw material batch used to produce the affected products. The cleanliness of the affected products could be compromised if cracks penetrate the surface of the instrument as a result of… |
| Mar 17, 2016 | Class II | Z-1340-2016 | Employee error | The firm received a customer complaint establishing that the product (Persona PS Articular Surfaces)information shown on the box differed by sides. One side showed P/N: 42-5114-008-18/ Lot: 62632101 and the other side showed P/N… |
| Mar 17, 2016 | Class II | Z-1341-2016 | Employee error | The firm received a customer complaint establishing that the product (Persona PS Articular Surfaces)information shown on the box differed by sides. One side showed P/N: 42-5114-008-18/ Lot: 62632101 and the other side showed P/N… |
| Jan 11, 2016 | Class II | Z-1157-2016 | Packaging | As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile. |
| Mar 10, 2015 | Class II | Z-1360-2015 | Nonconforming Material/Component | Zimmer, Inc is voluntarily recalling 22 lots of Persona¿ Anterior Referencing Sizer with Locking Boom, part number 42-5099-088-10. Devices are being removed from distribution due to nonconforming to print specifications. |
| Dec 4, 2014 | Class II | Z-0853-2015 | Process design | The affected lot was supplied by contract manufacturer and are potentially subject to disassociation of the magnet cover. Zimmer received one complaint indicating the magnet cover of a Persona Cemented Tibial Broach Inserter/Extractor… |
| Nov 25, 2014 | Class II | Z-1042-2015 | Process control | Potential for fracture of the tip of the product. The fractured tip is approximately 4mm x 7mm x 3.5mm in size. Retained tip may result in: pain, soft tissue irritation, soft tissue damage, or increased wear due to contact with the… |
| Oct 9, 2014 | Class II | Z-0198-2015 | Nonconforming Material/Component | Cleaning process validation failure. |
| Oct 7, 2014 | Class II | Z-0123-2015 | Process control | Affected product did not undergo heat treatment hardening step leading to the potential for deformation of the tip. |
| Aug 7, 2014 | Class II | Z-2575-2014 | Device Design | Reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). The Persona primary knee surgical technique has been updated. This field action correction is to ensure that all distributors and users of this… |
| Aug 7, 2014 | Class II | Z-2577-2014 | Device Design | Reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). The Persona primary knee surgical technique has been updated. This field action correction is to ensure that all distributors and users of this… |
| Aug 7, 2014 | Class II | Z-2580-2014 | Device Design | Reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). The Persona primary knee surgical technique has been updated. This field action correction is to ensure that all distributors and users of this… |
| Aug 7, 2014 | Class II | Z-2579-2014 | Device Design | Reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). The Persona primary knee surgical technique has been updated. This field action correction is to ensure that all distributors and users of this… |
| Aug 7, 2014 | Class II | Z-2578-2014 | Device Design | Reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). The Persona primary knee surgical technique has been updated. This field action correction is to ensure that all distributors and users of this… |
| Aug 7, 2014 | Class II | Z-2576-2014 | Device Design | Reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). The Persona primary knee surgical technique has been updated. This field action correction is to ensure that all distributors and users of this… |
| Jun 10, 2013 | Class II | Z-2296-2014 | Device Design | Zimmer had received complaints that reported breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). This is a retrospective recall which covers Zimmer's corrective actions taken earlier this year concerning the TASPs. |
| Jun 10, 2013 | Class II | Z-2297-2014 | Device Design | Zimmer had received complaints that reported breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). This is a retrospective recall which covers Zimmer's corrective actions taken earlier this year concerning the TASPs. |
| Jun 10, 2013 | Class II | Z-2299-2014 | Device Design | Zimmer had received complaints that reported breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). This is a retrospective recall which covers Zimmer's corrective actions taken earlier this year concerning the TASPs. |
| Nov 14, 2012 | Class II | Z-0539-2013 | Device Design | All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and replaced with enhanced products and… |
| Nov 14, 2012 | Class II | Z-0543-2013 | Device Design | All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and replaced with enhanced products and… |
| Nov 14, 2012 | Class II | Z-0544-2013 | Device Design | All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and replaced with enhanced products and… |
| Nov 14, 2012 | Class II | Z-0546-2013 | Device Design | All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and replaced with enhanced products and… |
| Nov 14, 2012 | Class II | Z-0547-2013 | Device Design | All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and replaced with enhanced products and… |
| Nov 14, 2012 | Class II | Z-0550-2013 | Device Design | All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and replaced with enhanced products and… |
| Nov 14, 2012 | Class II | Z-0553-2013 | Device Design | All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and replaced with enhanced products and… |
| Nov 14, 2012 | Class II | Z-0554-2013 | Device Design | All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and replaced with enhanced products and… |
| Nov 14, 2012 | Class II | Z-0540-2013 | Device Design | All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and replaced with enhanced products and… |
| Nov 14, 2012 | Class II | Z-0545-2013 | Device Design | All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and replaced with enhanced products and… |
| Nov 14, 2012 | Class II | Z-0548-2013 | Device Design | All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and replaced with enhanced products and… |
| Nov 14, 2012 | Class II | Z-0552-2013 | Device Design | All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and replaced with enhanced products and… |
| Nov 14, 2012 | Class II | Z-0541-2013 | Device Design | All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and replaced with enhanced products and… |
| Nov 14, 2012 | Class II | Z-0542-2013 | Device Design | All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and replaced with enhanced products and… |
| Nov 14, 2012 | Class II | Z-0549-2013 | Device Design | All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and replaced with enhanced products and… |
| Nov 14, 2012 | Class II | Z-0551-2013 | Device Design | All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and replaced with enhanced products and… |
| Nov 14, 2012 | Class II | Z-0555-2013 | Device Design | All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and replaced with enhanced products and… |
| Sep 7, 2012 | Class II | Z-2493-2012 | Device Design | Zimmer is initiating a recall of the Cemented Tibial Drill for the Zimmer Persona Personalized Knee System due to three reports being received as of August 29. 2012 for tibial cortex perforation during preparation of the tibial bone. The… |
The 5 latest of 39 recalls; the web page lists all.
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.
- 11 of the 14 ancestors have a recall of any class.
- Of its descendants, K121771 (Zimmer, Inc., 2012) has gone furthest, with 59 descendants of its own.
- 7 other devices also cite its predicate K936159.
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. 2012, 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?
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.
This device is intended for cemented use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113369 · printed Nov 5, 2026
Cite this page
510(k) Report. “K113369: Zimmer Persona 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/K113369
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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