510(k) · Cleared

Cleared

Neo CR Knee System

K120313510(k) TraditionalCleared Apr 20, 201279-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

Pipeline Orthopedics · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Cleared on Apr 20, 2012 as substantially equivalent to K023211 (Zimmer, Inc., 2002) and 2 other predicates after a 79-day review. Its family tree reaches back 5 generations to 1995. 3 later devices descend from it.

Decided: Apr 20, 2012
Review: 79 days
Class: Class II
Product code: JWH
Recalls: None
Predicates: 3

Its longest line of descent runs back 5 generations to K933785 (1995). 13 ancestors in all. 3 later devices descend from it, 3 citing it directly.

By dateBy generation

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 deviceK120313 Neo CR Knee SystemPipeline Orthopedics · 2012
Descendant · cites it directly · 1 of its ownK131368 Neo Knee SystemPipeline Orthopedics · 2013
Descendant · cites it directly · 1 of its ownK122500 Neo PS Knee SystemPipeline Orthopedics · 2013
Descendant · cites it directly · 0 of its ownK142388 Neo Total Knee SystemNew Era Orthopedics, LLC · 2014

Most influential descendants

Showing 3 of 3 · See all

K131368Neo Knee SystemPipeline Orthopedics · 2013 · cites it directly1descendant
K122500Neo PS Knee SystemPipeline Orthopedics · 2013 · cites it directly1descendant
K142388Neo Total Knee SystemNew Era Orthopedics, LLC · 2014 · cites it directly0descendants

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)	K120313	Neo CR Knee System	Pipeline Orthopedics	2012	—
+1	K131368	Neo Knee System	Pipeline Orthopedics	2013	—
+1	K122500	Neo PS Knee System	Pipeline Orthopedics	2013	—
+1	K142388	Neo Total Knee System	New Era Orthopedics, LLC	2014	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
1999	1	0
2000	1	0
2001	2	0
2004	1	0
2005	1	0
2007	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2013	2	0
2014	1	0

FIG. 1 — Lineage of K120313, 1995–2014Source: 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? (3)

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
*	K023211	Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral Components Summary page 2 …he following. Trade/Proprietary Name .. . . o _ Manufacturer 510(K)# \| Clearance ‘ , ) . Date NexGen Complete Knee Solution Cruciate Retaining {CR)-Flex Femoral Zimmer K023211 10/17/2002 Components ' Gender Solutions Natural-Knee Flex Zimmer K073286 03/07/2008 System Triathlon Cruciate Retaining (Cr) Tot…	Zimmer, Inc.	2002	6
*	K073286	Gender Solutions Natural-Knee Flex System Summary page 2 …earance ‘ , ) . Date NexGen Complete Knee Solution Cruciate Retaining {CR)-Flex Femoral Zimmer K023211 10/17/2002 Components ' Gender Solutions Natural-Knee Flex Zimmer K073286 03/07/2008 System Triathlon Cruciate Retaining (Cr) Total Stryker K040267 5/5/2004 Knee System Technological Characteristics: T…	Zimmer, Inc.	2008	5
*	K040267	Triathlon Cruciate Retaining (CR) Total Knee Summary page 2 …)-Flex Femoral Zimmer K023211 10/17/2002 Components ' Gender Solutions Natural-Knee Flex Zimmer K073286 03/07/2008 System Triathlon Cruciate Retaining (Cr) Total Stryker K040267 5/5/2004 Knee System Technological Characteristics: The metals and standard UHMWPE material from which the components are manuf…	Howmedica Osteonics Corp.	2004	1

Also cleared against K023211: 11 other devices →

What descends from it? (3)

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

Number	Device	Applicant	Decided	Descendants
K131368	Neo Knee System	Pipeline Orthopedics	2013	1
K122500	Neo PS Knee System	Pipeline Orthopedics	2013	1
K142388	Neo Total Knee System	New Era Orthopedics, LLC	2014	0

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?

The line of descent spans 17 years and passes through 2 companies; a new generation was cleared every 3.5 years on median.
10 of the 13 ancestors have a recall of any class.
Of its descendants, K131368 (Pipeline Orthopedics, 2013) has gone furthest, with 1 descendant of its own.
11 other devices also cite its predicate K023211.

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

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?

The NEO CR Knee System components are indicated for use in skeletally mature individuals, with severe knee pain and disability, with an intact posterior cruciate ligament, undergoing surgery for total knee replacement due to: Osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, moderate deformities and femoral condyle osteonecrosis. Failed osteotomies, failed partial knee replacement, or failed total knee replacement whose age, weight and…

Read the full statement (107 words)

Osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, moderate deformities and femoral condyle osteonecrosis.

Failed osteotomies, failed partial knee replacement, or failed total knee replacement whose age, weight and activity level are compatible with an adequate long-term result.

Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.

Moderate valgus, varus, or flexion deformities.

Neo CR Knee System components are indicated for use only with cement and are single use devices.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K120313 · printed Nov 6, 2026

Cite this page

510(k) Report. “K120313: Neo CR 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/K120313

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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