510(k) · Cleared

Cleared

Journey CR Knee System

K101499510(k) AbbreviatedCleared Aug 26, 201086-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

Smith & Nephew, Inc. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Cleared on Aug 26, 2010 as substantially equivalent to K951987 (Smith & Nephew Richards, Inc., 1995) and 5 other predicates after an 86-day review. Its family tree reaches back 4 generations to 1995. 45 later devices descend from it.

Decided: Aug 26, 2010
Review: 86 days
Class: Class II
Product code: JWH
Recalls: None
Predicates: 6

Its longest line of descent runs back 4 generations to K951987 (1995). 15 ancestors in all, the oldest K933787 (1994). 45 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 4 generations backK951987 Genesis II Total Knee SystemSmith & Nephew Richards, Inc. · 1995 · Recalled
3 generations backK030612 Genesis II Total Knee SystemSmith & Nephew, Inc. · 2003
2 generations backK032295 Genesis II Posterior Stabilized High Flexion Articular InsertSmith & Nephew, Inc. · 2003 · Recalled
1 generation backK041825 Smith & Nephew Genesis II Deep Flexion Cruciate Retaining Articular…Smith & Nephew, Inc. · 2005
This deviceK101499 Journey CR Knee SystemSmith & Nephew, Inc. · 2010
Descendant · cites it directly · 37 of its ownK121443 Journey II CR Knee SystemSmith & Nephew, Inc. · 2012
Descendant · 2 generations on · 18 of its ownK141934 Physica KR Knee SystemLima Corporate S.P.A. · 2015
Descendant · 2 generations on · 12 of its ownK141471 Journey II XR Knee SystemSmith & Nephew, Inc. · 2014
Descendant · 3 generations on · 8 of its ownK190911 Physica KR Liner and SMR Reverse Humeral LinerLimacorporate · 2019
Descendant · 3 generations on · 8 of its ownK152315 JOURNEY II Uni Tibial Base and InsertSmith & Nephew, Inc. · 2015

Showing 5 of 45 descendants. See all descendants

Descendants cleared per year

2011high 6 (2015) · low 0 (2016)2026

Most influential descendants

Showing 5 of 45 · See all

K121443Journey II CR Knee SystemSmith & Nephew, Inc. · 2012 · cites it directly37descendants
K141934Physica KR Knee SystemLima Corporate S.P.A. · 2015 · 2 generations on18descendants
K141471Journey II XR Knee SystemSmith & Nephew, Inc. · 2014 · 2 generations on12descendants
K190911Physica KR Liner and SMR Reverse Humeral LinerLimacorporate · 2019 · 3 generations on8descendants
K152315JOURNEY II Uni Tibial Base and InsertSmith & Nephew, Inc. · 2015 · 3 generations on8descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K951987	Genesis II Total Knee System	Smith & Nephew Richards, Inc.	1995	6
−3	K030612	Genesis II Total Knee System	Smith & Nephew, Inc.	2003	—
−2	K032295	Genesis II Posterior Stabilized High Flexion Articular Insert	Smith & Nephew, Inc.	2003	6
−1	K041825	Smith & Nephew Genesis II Deep Flexion Cruciate Retaining Articular Insert	Smith & Nephew, Inc.	2005	—
0 (this device)	K101499	Journey CR Knee System	Smith & Nephew, Inc.	2010	—
+1	K121443	Journey II CR Knee System	Smith & Nephew, Inc.	2012	—
+2	K141934	Physica KR Knee System	Lima Corporate S.P.A.	2015	—
+2	K141471	Journey II XR Knee System	Smith & Nephew, Inc.	2014	—
+3	K190911	Physica KR Liner and SMR Reverse Humeral Liner	Limacorporate	2019	—
+3	K152315	JOURNEY II Uni Tibial Base and Insert	Smith & Nephew, Inc.	2015	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	2	0
1995	1	0
1996	3	0
1999	1	0
2002	1	0
2004	1	0
2005	1	0
2006	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	1	0
2012	2	0
2013	3	0
2014	2	0
2015	6	0
2017	2	0
2019	3	0
2020	4	0
2021	4	0
2022	4	0
2023	3	0
2024	5	0
2025	4	0
2026	2	0

FIG. 1 — Lineage of K101499, 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? (6)

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
*	K951987	Genesis II Total Knee System Summary page 1 …y and patellar components currently used with the Journey BCS Knee System (K0425151 and may also be used with existing patellar components of the Genesis II Knee System IK951987). Technological Characteristics This 5101k) was prepared in accordance with the Agency's, "Draft Guidance for the Preparation of…	Smith & Nephew Richards, Inc.	1995	6
*	K023211	Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral Components Summary page 2 …K951987 8/22/1995 Nexgen Complete Knee Solution Zimmer Cruciate Retaining (CR1-Flex K023211 10/17/200 2 Femoral Components Genesis II Deep Flexion Cruciate…	Zimmer, Inc.	2002	6
*	K041825	Smith & Nephew Genesis II Deep Flexion Cruciate Retaining Articular Insert Summary page 2 …Femoral Components Genesis II Deep Flexion Cruciate K41857620 Smith & Nephew. Inc. Retaining Articular Insert K041825 7/6/2004 Howmedica, Inc Triathlon Cruciate Retaining (CR) K040267 5/5/2004…	Smith & Nephew, Inc.	2005	—
*	K040267	Triathlon Cruciate Retaining (CR) Total Knee Summary page 2 …20 Smith & Nephew. Inc. Retaining Articular Insert K041825 7/6/2004 Howmedica, Inc Triathlon Cruciate Retaining (CR) K040267 5/5/2004 Total Knee Smith & Nephew High Performance Knee'…	Howmedica Osteonics Corp.	2004	1
*	K042515	Smith & Nephew, Inc. High Performance Knee Summary page 1 …factured from UHMWPE. The Journey CR Knee system will use existing cemented Journey tibiak tray and patellar components currently used with the Journey BCS Knee System (K0425151 and may also be used with existing patellar components of the Genesis II Knee System IK951987). Technological Characteristics T…	Smith & Nephew, Inc.	2005	3
*	K062654	Depuy Sigma Cruciate Retaining Porocoat Femoral Components Summary page 2 …ee Smith & Nephew High Performance Knee' K042515 3/14/2005 DePuy Orthopaedics Sigma Cruciate Retaining (C/RI K062654 9/29/2006 Inc. Porocoat®D Femoral Components _________________ Conclusion As previo…	DePuy Orthopaedics, Inc.	2006	—

Also cleared against K951987: 31 other devices →

What descends from it? (45)

See all 45

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

Number	Device	Applicant	Decided	Descendants
K121443	Journey II CR Knee System	Smith & Nephew, Inc.	2012	37
K121393	Smith & Nephew, Inc. Total Knee System Instrumentation	Smith & Nephew, Inc.	2012	5
K110240	Smith & Nephew, Inc. Sureshot Distal Targeting System V2.1	Smith & Nephew, Inc.	2011	2

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 15 years and passes through 2 companies; a new generation was cleared every 5.5 years on median.
10 of the 15 ancestors have a recall of any class.
Of its descendants, K121443 (Smith & Nephew, Inc., 2012) has gone furthest, with 37 descendants of its own.
31 other devices also cite its predicate K951987.

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. 2010, 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?

Total knee components are indicated for rheumatoid arthritis; post-traumatic arthritis, osteoarthritis, or degenerative arthritis; failed osteotomies, unicompartmental replacement, or total knee replacement.

Smith & Nephew, Inc. Journey CR Knee System components are indicated for use only with cement and are single use devices.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K101499 · printed Nov 6, 2026

Cite this page

510(k) Report. “K101499: Journey 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/K101499

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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