510(k) · Cleared

Cleared

Nexgen Complete Knee Solution Mis Modular Tibial Plates and Keels

K052879510(k) SpecialCleared Nov 22, 200541-day reviewClass II21 CFR 888.3560

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 Nov 22, 2005 as substantially equivalent to K933785 (Zimmer, Inc., 1995) after a 41-day review. Its family tree reaches back 1 generation to 1995. 6 later devices descend from it.

Decided: Nov 22, 2005
Review: 41 days
Class: Class II
Product code: JWH
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K933785 (1995). 6 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK933785 Next Generation Knee SystemZimmer, Inc. · 1995 · Recalled
This deviceK052879 Nexgen Complete Knee Solution Mis Modular Tibial Plates and KeelsZimmer, Inc. · 2005
Descendant · cites it directly · 5 of its ownK173057 Zimmer Knee Joint Replacement Prostheses MR LabelingZimmer, Inc. · 2018 · Recalled
Descendant · 2 generations on · 4 of its ownK181947 Persona Revision Knee SystemZimmer, Inc. · 2018 · Recalled
Descendant · 2 generations on · 1 of its ownK191625 Persona Revision Knee SystemZimmer, Inc. · 2019 · Recalled
Descendant · 3 generations on · 0 of its ownK243724 Persona® Revision Knee System (Persona Revision SoluTion™ Femoral…Zimmer, Inc. · 2025
Descendant · 3 generations on · 0 of its ownK210829 Persona Revision Knee System Femoral Metaphyseal ConesZimmer, Inc. · 2021

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2018high 2 (2018) · low 0 (2020)2026

Most influential descendants

Showing 5 of 6 · See all

K173057Zimmer Knee Joint Replacement Prostheses MR LabelingZimmer, Inc. · 2018 · cites it directly5descendants
K181947Persona Revision Knee SystemZimmer, Inc. · 2018 · 2 generations on4descendants
K191625Persona Revision Knee SystemZimmer, Inc. · 2019 · 2 generations on1descendant
K243724Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components)Zimmer, Inc. · 2025 · 3 generations on0descendants
K210829Persona Revision Knee System Femoral Metaphyseal ConesZimmer, Inc. · 2021 · 3 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K933785	Next Generation Knee System	Zimmer, Inc.	1995	83
0 (this device)	K052879	Nexgen Complete Knee Solution Mis Modular Tibial Plates and Keels	Zimmer, Inc.	2005	—
+1	K173057	Zimmer Knee Joint Replacement Prostheses MR Labeling	Zimmer, Inc.	2018	2
+2	K181947	Persona Revision Knee System	Zimmer, Inc.	2018	1
+2	K191625	Persona Revision Knee System	Zimmer, Inc.	2019	1
+3	K243724	Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components)	Zimmer, Inc.	2025	—
+3	K210829	Persona Revision Knee System Femoral Metaphyseal Cones	Zimmer, Inc.	2021	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2018	2	0
2019	1	0
2021	2	0
2025	1	0

FIG. 1 — Lineage of K052879, 1995–2025Source: 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

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What was it cleared against? (1)

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
*	K933785	Next Generation Knee System Summary page 1 …21 CFR § 888.3560 Predicate Device: Nexcen®'Comnplete Knee Solution, manufactured by Zimmer, Inc., K933785, cleared January 30, 1995 Device Description: The Nex~en MIS Modular Tib…	Zimmer, Inc.	1995	83

Also cleared against K933785: 14 other devices →

What descends from it? (6)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K173057	Zimmer Knee Joint Replacement Prostheses MR Labeling	Zimmer, Inc.	2018	5

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?

Its one ancestor has a recall.
Of its descendants, K173057 (Zimmer, Inc., 2018) has gone furthest, with 5 descendants of its own.
14 other devices also cite its predicate K933785.

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.

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 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/K052879 · printed Nov 4, 2026

Cite this page

510(k) Report. “K052879: Nexgen Complete Knee Solution Mis Modular Tibial Plates and Keels.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K052879

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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