510(k) Report

510(k) · Cleared

Recalled · Class II · 2017

Zimmer Persona Knee System

K113369510(k) TraditionalCleared Mar 27, 2012133-day reviewClass II21 CFR 888.3560Recalls 39

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

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.

Other ancestors, by year clearedDescendants, by year cleared 1999: 1 other ancestor1996: 1 other ancestor1995: 1 other ancestor2007: 1 other ancestor2001: 2 other ancestors1997: 1 other ancestor2005: 1 other ancestor2000: 1 other ancestor2012: 3 descendants cleared2023: 8 descendants cleared2014: 6 descendants cleared2018: 5 descendants cleared2021: 12 descendants cleared2020: 10 descendants cleared2013: 3 descendants cleared2022: 7 descendants cleared2019: 5 descendants cleared2015: 4 descendants cleared2025: 7 descendants cleared2024: 10 descendants cleared2026: 9 descendants cleared2016: 6 descendants cleared2017: 1 descendant clearedK933785 · Next Generation Knee System · Zimmer, Inc. · 1995 · recalledK023211 · Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral Components · Zimmer, Inc. · 2002 · recalledK060370 · Nexgen Knee Gender Solutions Female (GSF) Femoral Components · Zimmer, Inc. · 2006 · recalledK070214 · Gender Solutions Natural-Knee Flex System · Zimmer, Inc. · 2007 · recalledK073286 · Gender Solutions Natural-Knee Flex System · Zimmer, Inc. · 2008 · recalled1995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 3 other ancestors3 generations back: 3 other ancestors 1 generation forward: 17 descendants2 generations forward: 22 descendants3 generations forward: 19 descendants4 generations forward: 13 descendants5 generations forward: 12 descendants6 generations forward: 6 descendants7 generations forward: 2 descendants8 generations forward: 3 descendants9 generations forward: 1 descendant10 generations forward: 1 descendant K073286 · Gender Solutions Natural-Knee Flex System · Zimmer, Inc. · 2008 · recalledK070214 · Gender Solutions Natural-Knee Flex System · Zimmer, Inc. · 2007 · recalledK060370 · Nexgen Knee Gender Solutions Female (GSF) Femoral Components · Zimmer, Inc. · 2006 · recalledK023211 · Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral Components · Zimmer, Inc. · 2002 · recalledK933785 · Next Generation Knee System · Zimmer, Inc. · 1995 · recalled−50+5+10
  1. Root · 5 generations backK933785 Next Generation Knee SystemZimmer, Inc. · 1995 · Recalled
  2. 4 generations backK023211 Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral…Zimmer, Inc. · 2002 · Recalled
  3. 3 generations backK060370 Nexgen Knee Gender Solutions Female (GSF) Femoral ComponentsZimmer, Inc. · 2006 · Recalled
  4. 2 generations backK070214 Gender Solutions Natural-Knee Flex SystemZimmer, Inc. · 2007 · Recalled
  5. 1 generation backK073286 Gender Solutions Natural-Knee Flex SystemZimmer, Inc. · 2008 · Recalled
  6. This deviceK113369 Zimmer Persona Knee SystemZimmer, Inc. · 2012
  7. Descendant · cites it directly · 59 of its ownK121771 Zimmer Persona the Personalized Knee SystemZimmer, Inc. · 2012 · Recalled
  8. Descendant · cites it directly · 26 of its ownK140833 Itotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc. · 2014
  9. Descendant · cites it directly · 25 of its ownK122765 Persona Natural Tibia BaseplatesZimmer, Inc. · 2012 · Recalled
  10. Descendant · 2 generations on · 24 of its ownK142404 iTotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc. · 2014 · Recalled
  11. 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

2012: 32013: 32014: 62015: 42016: 62017: 12018: 52019: 52020: 102021: 122022: 72023: 82024: 102025: 72026: 9
2012high 12 (2021) · low 1 (2017)2026

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

GenerationNumberDeviceApplicantDecidedRecalls
−5K933785Next Generation Knee SystemZimmer, Inc.199583
−4K023211Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral ComponentsZimmer, Inc.20026
−3K060370Nexgen Knee Gender Solutions Female (GSF) Femoral ComponentsZimmer, Inc.200617
−2K070214Gender Solutions Natural-Knee Flex SystemZimmer, Inc.200763
−1K073286Gender Solutions Natural-Knee Flex SystemZimmer, Inc.20085
0 (this device)K113369Zimmer Persona Knee SystemZimmer, Inc.2012—
+1K121771Zimmer Persona the Personalized Knee SystemZimmer, Inc.20122
+1K140833Itotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc.2014—
+1K122765Persona Natural Tibia BaseplatesZimmer, Inc.20122
+2K142404iTotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc.20142
+2K142161Itotal Cruciate Retaining (CR) Knee Replacement System, Itotal Posterior…Conformis, Inc.20146

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510
199610
199710
199910
200010
200120
200510
200710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201230
201330
201460
201540
201660
201710
201850
201950
2020100
2021120
202270
202380
2024100
202570
202690
FIG. 1 — Lineage of K113369, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K221479 Persona Personalized Knee Systemscore 22.4 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K936159Natural-Knee II System
Summary 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,…
Intermedics Orthopedics19956
*K070214Gender Solutions Natural-Knee Flex System
Summary 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,…
Zimmer, Inc.200763
*K073286Gender Solutions Natural-Knee Flex System
Summary 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…
Zimmer, Inc.20085
*K933785Next Generation Knee System
Summary page 1
…2008) NextGen Complete Knee System, manufactured by Zimmer, Inc. (K933785, cleared January 30,.1995) NexGen Complete Knee Solution Legacy Posterior…
Zimmer, Inc.199583
*K960279Nexgen 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…
Zimmer, Inc.199621
*K991581Nexgen 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…
Zimmer, Inc.19997
*K023211Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral Components
Summary 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)…
Zimmer, Inc.20026
*K060370Nexgen Knee Gender Solutions Female (GSF) Femoral Components
Summary 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…
Zimmer, Inc.200617

Also cleared against K936159: 7 other devices →

What descends from it? (96)

See all 96

17 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K121771Zimmer Persona the Personalized Knee SystemZimmer, Inc.201259
K140833Itotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc.201426
K122765Persona Natural Tibia BaseplatesZimmer, Inc.201225
K130143Persona Natural Tibia BaseplatesZimmer, Inc.201321
K122745Zimmer Persona the Personalized Knee SystemZimmer, Inc.201221
K142787Zimmer Persona Personalized Knee SystemZimmer, Inc.201416
K172524Zimmer Persona Personalized Knee SystemZimmer, Inc.201815
K123459Zimmer Persona TM Personalized Knee SystemZimmer, Inc.20139
K221479Persona Personalized Knee SystemZimmer, Inc.20228
K133737Zimmer (R) Persona the Personalized Kee System 14X +30MM Tapered Stem ExtensionZimmer, Inc.20145

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Aug 7, 2017Class IIZ-1806-2018Under Investigation by firmThere 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, 2017Class IIZ-1808-2018Under Investigation by firmThere 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, 2017Class IIZ-1805-2018Under Investigation by firmThere 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, 2017Class IIZ-1807-2018Under Investigation by firmThere 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, 2016Class IIZ-1340-2016Employee errorThe 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, 2016Class IIZ-1341-2016Employee errorThe 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, 2016Class IIZ-1157-2016PackagingAs 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, 2015Class IIZ-1360-2015Nonconforming Material/ComponentZimmer, 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, 2014Class IIZ-0853-2015Process designThe 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, 2014Class IIZ-1042-2015Process controlPotential 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, 2014Class IIZ-0198-2015Nonconforming Material/ComponentCleaning process validation failure.
Oct 7, 2014Class IIZ-0123-2015Process controlAffected product did not undergo heat treatment hardening step leading to the potential for deformation of the tip.
Aug 7, 2014Class IIZ-2575-2014Device DesignReports 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, 2014Class IIZ-2577-2014Device DesignReports 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, 2014Class IIZ-2580-2014Device DesignReports 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, 2014Class IIZ-2579-2014Device DesignReports 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, 2014Class IIZ-2578-2014Device DesignReports 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, 2014Class IIZ-2576-2014Device DesignReports 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, 2013Class IIZ-2296-2014Device DesignZimmer 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, 2013Class IIZ-2297-2014Device DesignZimmer 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, 2013Class IIZ-2299-2014Device DesignZimmer 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, 2012Class IIZ-0539-2013Device DesignAll 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, 2012Class IIZ-0543-2013Device DesignAll 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, 2012Class IIZ-0544-2013Device DesignAll 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, 2012Class IIZ-0546-2013Device DesignAll 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, 2012Class IIZ-0547-2013Device DesignAll 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, 2012Class IIZ-0550-2013Device DesignAll 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, 2012Class IIZ-0553-2013Device DesignAll 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, 2012Class IIZ-0554-2013Device DesignAll 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, 2012Class IIZ-0540-2013Device DesignAll 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, 2012Class IIZ-0545-2013Device DesignAll 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, 2012Class IIZ-0548-2013Device DesignAll 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, 2012Class IIZ-0552-2013Device DesignAll 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, 2012Class IIZ-0541-2013Device DesignAll 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, 2012Class IIZ-0542-2013Device DesignAll 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, 2012Class IIZ-0549-2013Device DesignAll 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, 2012Class IIZ-0551-2013Device DesignAll 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, 2012Class IIZ-0555-2013Device DesignAll 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, 2012Class IIZ-2493-2012Device DesignZimmer 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…

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 devices

JWH 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

2007: 182008: 172009: 112010: 192011: 252012: 332013: 312014: 332015: 272016: 182017: 252018: 252019: 282020: 222021: 242022: 172023: 202024: 192025: 202026 (partial year): 12
2007high 33 (2012) · low 11 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JWH

55in 2025

2007: 74 days median2008: 81 days median2009: 168 days median2010: 85 days median2011: 87 days median2012: 85 days median2013: 128 days median2014: 98 days median2015: 87 days median2016: 88 days median2017: 118 days median2018: 90 days median2019: 133 days median2020: 59 days median2021: 61 days median2022: 56 days median2023: 57 days median2024: 89 days median2025: 55 days median2026 (partial year): 63 days median
2007high 168 (2009) · low 55 (2025)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JWH

2in 2025

2007: 142008: 102009: 1092010: 322011: 272012: 852013: 312014: 132015: 112016: 172017: 612018: 142019: 52020: 22021: 82022: 122023: 672024: 72025: 22026 (partial year): 4
2007high 109 (2009) · low 2 (2020)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JWH

9,306in 2025

2007: 1,3052008: 1,4832009: 1,8702010: 3,2862011: 5,1332012: 5,2032013: 6,1352014: 6,7222015: 6,8812016: 7,5862017: 12,2632018: 14,0712019: 14,9872020: 12,5922021: 9,4082022: 8,3642023: 8,9472024: 10,8282025: 9,306
2007high 14,987 (2019) · low 1,305 (2007)2025

MAUDE reports naming product code JWH, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071874141,305
20081781101,483
2009111681091,870
20101985323,286
20112587275,133
20123385855,203
201331128316,135
20143398136,722
20152787116,881
20161888177,586
2017251186112,263
201825901414,071
201928133514,987
20202259212,592
2021246189,408
20221756128,364
20232057678,947
20241989710,828
2025205529,306
202612634—

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.

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

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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