510(k) · Cleared

Recalled · Class II · 2017

Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral Components

K023211510(k) SpecialCleared Oct 17, 200221-day reviewClass II21 CFR 888.3560Recalls 6

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 17, 2002 as substantially equivalent to K933785 (Zimmer, Inc., 1995) and 1 other predicate after a 21-day review. Its family tree reaches back 1 generation to 1995. 293 later devices descend from it. It has been recalled 6 times.

Decided: Oct 17, 2002
Review: 21 days
Class: Class II
Product code: JWH
Recalls: 6
Predicates: 2

Its longest line of descent runs back 1 generation to K933785 (1995). 2 ancestors in all. 293 later devices descend from it, 12 citing it directly.

By dateBy generation

Root · 1 generation backK933785 Next Generation Knee SystemZimmer, Inc. · 1995 · Recalled
This deviceK023211 Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral…Zimmer, Inc. · 2002
Descendant · cites it directly · 197 of its ownK060370 Nexgen Knee Gender Solutions Female (GSF) Femoral ComponentsZimmer, Inc. · 2006 · Recalled
Descendant · cites it directly · 193 of its ownK031061 Nexgen Porous, Uncemented Femoral and Tibial Baseplate ComponentsZimmer, Inc. · 2003 · Recalled
Descendant · 2 generations on · 123 of its ownK070214 Gender Solutions Natural-Knee Flex SystemZimmer, Inc. · 2007 · Recalled
Descendant · 2 generations on · 122 of its ownK070695 Zimmer Patellofemoral Joint ProsthesisZimmer, Inc. · 2007 · Recalled
Descendant · 3 generations on · 117 of its ownK073286 Gender Solutions Natural-Knee Flex SystemZimmer, Inc. · 2008 · Recalled

Showing 5 of 293 descendants. See all descendants

Descendants cleared per year

2003high 28 (2025) · low 1 (2003)2026

Most influential descendants

Showing 5 of 293 · See all

K060370Nexgen Knee Gender Solutions Female (GSF) Femoral ComponentsZimmer, Inc. · 2006 · cites it directly197descendants
K031061Nexgen Porous, Uncemented Femoral and Tibial Baseplate ComponentsZimmer, Inc. · 2003 · cites it directly193descendants
K070214Gender Solutions Natural-Knee Flex SystemZimmer, Inc. · 2007 · 2 generations on123descendants
K070695Zimmer Patellofemoral Joint ProsthesisZimmer, Inc. · 2007 · 2 generations on122descendants
K073286Gender Solutions Natural-Knee Flex SystemZimmer, Inc. · 2008 · 3 generations on117descendants

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)	K023211	Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral Components	Zimmer, Inc.	2002	—
+1	K060370	Nexgen Knee Gender Solutions Female (GSF) Femoral Components	Zimmer, Inc.	2006	17
+1	K031061	Nexgen Porous, Uncemented Femoral and Tibial Baseplate Components	Zimmer, Inc.	2003	24
+2	K070214	Gender Solutions Natural-Knee Flex System	Zimmer, Inc.	2007	63
+2	K070695	Zimmer Patellofemoral Joint Prosthesis	Zimmer, Inc.	2007	5
+3	K073286	Gender Solutions Natural-Knee Flex System	Zimmer, Inc.	2008	5

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2004	2	0
2005	1	0
2006	1	0
2007	5	0
2008	2	0
2009	2	0
2010	4	0
2011	9	0
2012	16	0
2013	18	0
2014	17	0
2015	13	0
2016	10	0
2017	9	0
2018	12	0
2019	13	0
2020	24	0
2021	26	0
2022	18	0
2023	21	0
2024	21	0
2025	28	0
2026	20	0

FIG. 1 — Lineage of K023211, 1995–2026Source: 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? (2)

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 …knee prosthesis - 21 CFR 5 888.3560 Predicate Devices: NexGen CR knee, manufactured by Zimmer, K933785, cleared January 30, 1995 and the NexGen LPS-Flex knee, manufactured by Zimmer,…	Zimmer, Inc.	1995	83
*	K991581	Nexgen Complete Knee Solution Legacy Posterior Stabilized (LPS); LPS-Flex Fixed Bearing… Summary page 1 …K933785, cleared January 30, 1995 and the NexGen LPS-Flex knee, manufactured by Zimmer, K99 1581, cleared July 30, 1999. Device Description: The NexGen CR-Flex femoral components are part…	Zimmer, Inc.	1999	7

Also cleared against K933785: 14 other devices →

What descends from it? (293)

See all 293

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

Number	Device	Applicant	Decided	Descendants
K060370	Nexgen Knee Gender Solutions Female (GSF) Femoral Components	Zimmer, Inc.	2006	197
K031061	Nexgen Porous, Uncemented Femoral and Tibial Baseplate Components	Zimmer, Inc.	2003	193
K113369	Zimmer Persona Knee System	Zimmer, Inc.	2012	96
K101499	Journey CR Knee System	Smith & Nephew, Inc.	2010	45
K122745	Zimmer Persona the Personalized Knee System	Zimmer, Inc.	2012	21
K173057	Zimmer Knee Joint Replacement Prostheses MR Labeling	Zimmer, Inc.	2018	5
K120313	Neo CR Knee System	Pipeline Orthopedics	2012	3
K170534	Prolixus Total Knee System	Otis Biotech Co., Ltd.	2017	2
K113122	Pipeline CR Primary Knee System	Pipeline Orthopedics	2012	1
K140222	Saiph Knee System	Matortho	2014	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Nov 29, 2017	Class II	Z-1047-2018	Packaging	The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.
Nov 29, 2017	Class II	Z-1049-2018	Packaging	The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.
Nov 29, 2017	Class II	Z-1050-2018	Packaging	The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.
Nov 29, 2017	Class II	Z-1046-2018	Packaging	The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.
Nov 29, 2017	Class II	Z-1048-2018	Packaging	The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.
Jan 11, 2016	Class II	Z-0831-2016	Process control	LDPE bag containing the implant adheres to the highly polished implant surface.

The 5 latest of 6 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

2 of the 2 ancestors have a recall of any class.
Of its descendants, K060370 (Zimmer, Inc., 2006) has gone furthest, with 197 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, dyshnction, or prior patellectomy), and moderate valgus, varus, or flexion deformities. - The salvage of previously failed surgical…

Read the full statement (139 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, dyshnction, or prior patellectomy), and moderate valgus, varus, or flexion deformities.

- The salvage of previously failed surgical attempts if the knee can be satisfactorily balanced and stabilized at the time of surgery.

This device is intended for cemented use only

Specific uses with CR-Flex femorals:

- Provides increased flexion capability for patients who have both the flexibility and desire to increase their flexion range.

- The CR-Flex femoral is designed for use with a hnctional posterior cruciate ligament and when load bearing range of motion (ROM) is expected to be less than or equal to 155 degrees.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K023211 · printed Nov 6, 2026

Cite this page

510(k) Report. “K023211: Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral Components.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023211

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