510(k) · Cleared

Recalled · Class II · 2023

Journey II BCS Constrained Inserts

K140555510(k) TraditionalCleared May 29, 201486-day reviewClass II21 CFR 888.3560Recalls 2

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 May 29, 2014 after an 86-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it. It has been recalled 2 times.

Decided: May 29, 2014
Review: 86 days
Class: Class II
Product code: JWH
Recalls: 2
Predicates: 0

6 later devices descend from it, 2 citing it directly.

This deviceK140555 Journey II BCS Constrained InsertsSmith & Nephew, Inc. · 2014
Descendant · cites it directly · 3 of its ownK230653 Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee…Smith & Nephew, Inc. · 2023 · Recalled
Descendant · cites it directly · 1 of its ownK211671 Journey II Mid-Level Tibial InsertsSmith & Nephew, Inc. · 2021
Descendant · 2 generations on · 0 of its ownK261462 LANDMARK Total Knee SystemSmith & Nephew, Inc. · 2026
Descendant · 2 generations on · 0 of its ownK250677 LEGION Total Knee SystemSmith & Nephew, Inc. · 2025
Descendant · 2 generations on · 0 of its ownK241260 ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc. · 2024

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2021high 2 (2024) · low 0 (2022)2026

Most influential descendants

Showing 5 of 6 · See all

K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…Smith & Nephew, Inc. · 2023 · cites it directly3descendants
K211671Journey II Mid-Level Tibial InsertsSmith & Nephew, Inc. · 2021 · cites it directly1descendant
K261462LANDMARK Total Knee SystemSmith & Nephew, Inc. · 2026 · 2 generations on0descendants
K250677LEGION Total Knee SystemSmith & Nephew, Inc. · 2025 · 2 generations on0descendants
K241260ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc. · 2024 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K140555	Journey II BCS Constrained Inserts	Smith & Nephew, Inc.	2014	—
+1	K230653	Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System…	Smith & Nephew, Inc.	2023	1
+1	K211671	Journey II Mid-Level Tibial Inserts	Smith & Nephew, Inc.	2021	—
+2	K261462	LANDMARK Total Knee System	Smith & Nephew, Inc.	2026	—
+2	K250677	LEGION Total Knee System	Smith & Nephew, Inc.	2025	—
+2	K241260	ACTIFY™ Unicondylar Knee System	Globus Medical, Inc.	2024	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2021	1	0
2023	1	0
2024	2	0
2025	1	0
2026	1	0

FIG. 1 — Lineage of K140555, 2014–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (6)

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

Number	Device	Applicant	Decided	Descendants
K230653	Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…	Smith & Nephew, Inc.	2023	3
K211671	Journey II Mid-Level Tibial Inserts	Smith & Nephew, Inc.	2021	1

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Sep 27, 2023	Class II	Z-0158-2024	Component change control	The JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM. And also, a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS…
Sep 27, 2023	Class II	Z-0157-2024	Component change control	The JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM. And also, a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS…

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K230653 (Smith & Nephew, Inc., 2023) has gone furthest, with 3 descendants 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. 2014, 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	—

https://510kreport.com/device/K140555 · printed Nov 6, 2026

Cite this page

510(k) Report. “K140555: Journey II BCS Constrained Inserts.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140555

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026