510(k) · Cleared

Recalled · Class II · 2026

Persona Revision Knee System

K181947510(k) TraditionalCleared Oct 25, 201897-day reviewClass II21 CFR 888.3560Recalls 1

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 Oct 25, 2018 as substantially equivalent to K133737 (Zimmer, Inc., 2014) and 23 other predicates after a 97-day review. Its family tree reaches back 11 generations to 1981. 4 later devices descend from it. It has been recalled once.

Decided: Oct 25, 2018
Review: 97 days
Class: Class II
Product code: JWH
Recalls: 1
Predicates: 24

Its longest line of descent runs back 11 generations to K810258 (1981). 159 ancestors in all. 4 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 11 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
7 generations between
3 generations backK120370 Vivacit-E Vitamin E Highly Crosslinked Polyethylene LinersZimmer, Inc. · 2012
2 generations backK121771 Zimmer Persona the Personalized Knee SystemZimmer, Inc. · 2012 · Recalled
1 generation backK123459 Zimmer Persona TM Personalized Knee SystemZimmer, Inc. · 2013 · Recalled
This deviceK181947 Persona Revision Knee SystemZimmer, Inc. · 2018
Descendant · cites it directly · 1 of its ownK191625 Persona Revision Knee SystemZimmer, Inc. · 2019 · Recalled
Descendant · cites it directly · 0 of its ownK243724 Persona® Revision Knee System (Persona Revision SoluTion™ Femoral…Zimmer, Inc. · 2025
Descendant · cites it directly · 0 of its ownK210829 Persona Revision Knee System Femoral Metaphyseal ConesZimmer, Inc. · 2021
Descendant · 2 generations on · 0 of its ownK210551 Persona Revision Knee SystemZimmer, Inc. · 2021 · Recalled

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 backK100048 E1 Antioxidant Infused TechnologyBiomet Manufacturing Corp · 2010
3 generations backK120370 Vivacit-E Vitamin E Highly Crosslinked Polyethylene LinersZimmer, Inc. · 2012
2 generations backK121771 Zimmer Persona the Personalized Knee SystemZimmer, Inc. · 2012 · Recalled
1 generation backK123459 Zimmer Persona TM Personalized Knee SystemZimmer, Inc. · 2013 · Recalled
This deviceK181947 Persona Revision Knee SystemZimmer, Inc. · 2018

Most influential descendants

Showing 4 of 4 · See all

K191625Persona Revision Knee SystemZimmer, Inc. · 2019 · cites it directly1descendant
K243724Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components)Zimmer, Inc. · 2025 · cites it directly0descendants
K210829Persona Revision Knee System Femoral Metaphyseal ConesZimmer, Inc. · 2021 · cites it directly0descendants
K210551Persona Revision Knee SystemZimmer, Inc. · 2021 · 2 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	K100048	E1 Antioxidant Infused Technology	Biomet Manufacturing Corp	2010	—
−3	K120370	Vivacit-E Vitamin E Highly Crosslinked Polyethylene Liners	Zimmer, Inc.	2012	—
−2	K121771	Zimmer Persona the Personalized Knee System	Zimmer, Inc.	2012	2
−1	K123459	Zimmer Persona TM Personalized Knee System	Zimmer, Inc.	2013	10
0 (this device)	K181947	Persona Revision Knee System	Zimmer, Inc.	2018	—
+1	K191625	Persona Revision Knee System	Zimmer, Inc.	2019	1
+1	K243724	Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components)	Zimmer, Inc.	2025	—
+1	K210829	Persona Revision Knee System Femoral Metaphyseal Cones	Zimmer, Inc.	2021	—
+2	K210551	Persona Revision Knee System	Zimmer, Inc.	2021	1

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1984	1	0
1986	1	0
1987	2	0
1989	2	0
1991	2	0
1992	4	0
1993	2	0
1994	7	0
1995	12	0
1996	8	0
1997	8	0
1998	5	0
1999	6	0
2000	6	0
2001	6	0
2002	5	0
2003	10	0
2004	10	0
2005	10	0
2006	7	0
2007	7	0
2008	5	0
2009	3	0
2010	4	0
2011	4	0
2012	4	0
2013	1	0
2014	3	0
2015	1	0
2017	1	0
2018	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2019	1	0
2021	2	0
2025	1	0

FIG. 1 — Lineage of K181947, 1981–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) Report

What was it cleared against? (24)

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	Applicant	Decided	Recalls
*	K133737	Zimmer (R) Persona the Personalized Kee System 14X +30MM Tapered Stem Extension Summary page 4 …Additive (21 CFR 888.3560) Predicate Devices: Zimmer Persona K133737 The Personalized Knee System K130143…	Zimmer, Inc.	2014	—
*	K130143	Persona Natural Tibia Baseplates Summary page 4 …Zimmer Persona K133737 The Personalized Knee System K130143 K123459…	Zimmer, Inc.	2013	—
*	K123459	Zimmer Persona TM Personalized Knee System Summary page 4 …The Personalized Knee System K130143 K123459 K122765…	Zimmer, Inc.	2013	10
*	K122765	Persona Natural Tibia Baseplates Summary page 4 …K123459 K122765 K121771…	Zimmer, Inc.	2012	2
*	K121771	Zimmer Persona the Personalized Knee System Summary page 4 …K122765 K121771 K113369…	Zimmer, Inc.	2012	2
*	K113369	Zimmer Persona Knee System Summary page 4 …K121771 K113369 NexGen Complete Knee Solution K173057…	Zimmer, Inc.	2012	39
*	K173057	Zimmer Knee Joint Replacement Prostheses MR Labeling Summary page 4 …K113369 NexGen Complete Knee Solution K173057 K152494…	Zimmer, Inc.	2018	2
*	K152494	Zimmer NexGen Complete Knee Solution Tibial and Femoral Augments Summary page 4 …NexGen Complete Knee Solution K173057 K152494 K181947 - Page 2 of 6…	Zimmer, Inc.	2015	1
*	K960279	Nexgen Compl. Knee Sol. Legacy Posterior Stabilized/Constrained Condylar Knee Femoral… Summary page 5 …K152494 K181947 - Page 2 of 6 K960279 K946150…	Zimmer, Inc.	1996	21
*	K946150	Cruciate Retaining (Augmentable) and Constrained Condylar Knee (CCK) Summary page 5 …K960279 K946150 K933785 NexG…	Zimmer, Inc.	1995	—
*	K933785	Next Generation Knee System Summary page 5 …279 K946150 K933785 NexGen TM Augments and Cones K103517…	Zimmer, Inc.	1995	83
*	K103517	Trabecular Metal Femoral Cone Augments Summary page 5 …50 K933785 NexGen TM Augments and Cones K103517 K040630…	Zimmer Trabecular Metal Technology, Inc.	2011	—
*	K040630	Trabecular Metal Femoral Cone Augments, Model 03-125-ZZZZ Summary page 5 …85 NexGen TM Augments and Cones K103517 K040630 K031962…	Implex Corp.	2004	2
*	K031962	Nexgen Trabecular Metal Tibial Cone Augments Summary page 5 …517 K040630 K031962 K024161 Vang…	Implex Corp.	2004	—
*	K024161	Nexgen Complete Knee Solution - Trabecular Metal Augments Summary page 5 …630 K031962 K024161 Vanguard SSK 360 Revision Knee K171054 Syst…	Implex Corp.	2003	2
*	K171054	Biomet Knee Joint Replacement Prostheses Summary page 5 …62 K024161 Vanguard SSK 360 Revision Knee K171054 System K121149…	Biomet, Inc.	2017	4
*	K121149	Vanguard SSK 360 Revision Knee System Summary page 5 …61 Vanguard SSK 360 Revision Knee K171054 System K121149 K093293…	Biomet Manufacturing Corp	2012	—
*	K093293	Vanguard 360 Revision Knee System Summary page 5 …054 System K121149 K093293 K042757 Natu…	Biomet, Inc.	2010	5
*	K042757	Vanguard SSK Knee System Summary page 5 …149 K093293 K042757 Natural-Knee II K173057…	Biomet, Inc.	2005	1
*	K023528	Natural-Knee II Cemented Modular Tibial Baseplate Summary page 5 …57 Natural-Knee II K173057 K023528 K013031…	Centerplus Orthopedics, Inc.	2003	5
*	K013031	Most Options System Summary page 5 …057 K023528 K013031 K982903…	Sulzer Orthopedics, Inc.	2001	3
*	K982903	Sulzer Orthopedics Fluted Stems Summary page 5 …528 K013031 K982903 K973412…	Sulzer Orthopedics, Inc.	1998	—
*	K973412	Natural-Knee II Constrained Knee System Summary page 5 …031 K982903 K973412 K972501 Purpose and Device Description: The pur…	Sulzer Orthopedics, Inc.	1997	2
*	K972501	Apollo Revision/Constrained Knee System Summary page 5 …903 K973412 K972501 Purpose and Device Description: The purpose of this submission is for introduction of the Pe…	Sulzer Orthopedics, Inc.	1997	1

What descends from it? (4)

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

Number	Device	Applicant	Decided	Descendants
K191625	Persona Revision Knee System	Zimmer, Inc.	2019	1
K243724	Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components)	Zimmer, Inc.	2025	0
K210829	Persona Revision Knee System Femoral Metaphyseal Cones	Zimmer, Inc.	2021	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
May 11, 2026	Class II	Z-2578-2026	Labeling Change Control	Firm received a complaint with no clinical impact in which a posterior augment was found within the distal augment package.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 37 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
75 of the 159 ancestors have a recall of any class.
Of its descendants, K191625 (Zimmer, Inc., 2019) has gone furthest, with 1 descendant of its own.

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. 2018, this device’s year, is highlighted.

FDA decisions per year · JWH

20in 2025

2007high 33 (2012) · low 11 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JWH

55in 2025

2007high 168 (2009) · low 55 (2025)2026

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

Recalls per year · JWH

2in 2025

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

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

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…

Read the full statement (137 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 components may be used cemented or uncemented (biological fixation). Augments may be attached via bone cement or screw to the tibial plates and/or femoral components. Splined stem extension components are intended to be used press-fit (uncemented). All other femoral component, tibial plate, stem extension, and femoral and tibial augment components are indicated for cemented use only.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K181947 · printed Nov 6, 2026

Cite this page

510(k) Report. “K181947: Persona Revision 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/K181947

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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