510(k) Report

510(k) · Cleared

Cleared

Journey II XR Knee System

K141471510(k) TraditionalCleared Nov 14, 2014164-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 Nov 14, 2014 as substantially equivalent to K904448 (Biopro, Inc., 1991) and 3 other predicates after a 164-day review. Its family tree reaches back 7 generations to 1995. 12 later devices descend from it.

Decided
Nov 14, 2014
Review
164 days
Class
Class II
Product code
JWH
Recalls
None
Predicates
4

Its longest line of descent runs back 7 generations to K951987 (1995). 23 ancestors in all, the oldest K904448 (1991). 12 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1991: 1 other ancestor2010: 1 other ancestor1996: 4 other ancestors2009: 1 other ancestor2007: 1 other ancestor2006: 1 other ancestor2005: 1 other ancestor2004: 1 other ancestor2002: 1 other ancestor1999: 1 other ancestor1995: 1 other ancestor1994: 2 other ancestors2015: 2 descendants cleared2017: 1 descendant cleared2023: 1 descendant cleared2019: 2 descendants cleared2020: 1 descendant cleared2024: 3 descendants cleared2022: 1 descendant cleared2026: 1 descendant clearedK951987 · Genesis II Total Knee System · Smith & Nephew Richards, Inc. · 1995 · recalled×2: 2 generations cleared close together, K030612 (2003), K032295 (2003) K041825 · Smith & Nephew Genesis II Deep Flexion Cruciate Retaining Articular Insert · Smith & Nephew, Inc. · 2005K071071 · Crosslinked Polyethylene Articular Inserts · Smith & Nephew, Inc. · 2007 · recalledK111711 · Journey II BCS Knee System · Smith & Nephew, Inc. · 2011 · recalledK121443 · Journey II CR Knee System · Smith & Nephew, Inc. · 20121990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 2 other ancestors3 generations back: 7 other ancestors4 generations back: 6 other ancestors 1 generation forward: 3 descendants2 generations forward: 3 descendants3 generations forward: 6 descendants K121443 · Journey II CR Knee System · Smith & Nephew, Inc. · 2012K111711 · Journey II BCS Knee System · Smith & Nephew, Inc. · 2011 · recalledK071071 · Crosslinked Polyethylene Articular Inserts · Smith & Nephew, Inc. · 2007 · recalledK041825 · Smith & Nephew Genesis II Deep Flexion Cruciate Retaining Articular Insert · Smith & Nephew, Inc. · 2005K032295 · Genesis II Posterior Stabilized High Flexion Articular Insert · Smith & Nephew, Inc. · 2003 · recalledK030612 · Genesis II Total Knee System · Smith & Nephew, Inc. · 2003K951987 · Genesis II Total Knee System · Smith & Nephew Richards, Inc. · 1995 · recalled−50
  1. Root · 7 generations backK951987 Genesis II Total Knee SystemSmith & Nephew Richards, Inc. · 1995 · Recalled
  2. 6 generations backK030612 Genesis II Total Knee SystemSmith & Nephew, Inc. · 2003
  3. 5 generations backK032295 Genesis II Posterior Stabilized High Flexion Articular InsertSmith & Nephew, Inc. · 2003 · Recalled
  4. 4 generations backK041825 Smith & Nephew Genesis II Deep Flexion Cruciate Retaining Articular…Smith & Nephew, Inc. · 2005
  5. 3 generations backK071071 Crosslinked Polyethylene Articular InsertsSmith & Nephew, Inc. · 2007 · Recalled
  6. 2 generations backK111711 Journey II BCS Knee SystemSmith & Nephew, Inc. · 2011 · Recalled
  7. 1 generation backK121443 Journey II CR Knee SystemSmith & Nephew, Inc. · 2012
  8. This deviceK141471 Journey II XR Knee SystemSmith & Nephew, Inc. · 2014
  9. Descendant · cites it directly · 8 of its ownK152315 JOURNEY II Uni Tibial Base and InsertSmith & Nephew, Inc. · 2015
  10. Descendant · 2 generations on · 7 of its ownK190085 Journey II Unicompartmental Knee SystemSmith & Nephew, Inc. · 2019 · Recalled
  11. Descendant · cites it directly · 4 of its ownK152726 JOURNEY II XR Knee SystemSmith & Nephew, Inc. · 2015
  12. Descendant · 2 generations on · 3 of its ownK230653 Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee…Smith & Nephew, Inc. · 2023 · Recalled
  13. Descendant · 3 generations on · 1 of its ownK191211 JOURNEY II Unicompartmental Knee SystemSmith & Nephew, Inc. · 2019

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

2015: 22017: 12019: 22020: 12022: 12023: 12024: 32026: 1
2015high 3 (2024) · low 0 (2016)2026

Most influential descendants

Showing 5 of 12 · See all
  • K152315JOURNEY II Uni Tibial Base and InsertSmith & Nephew, Inc. · 2015 · cites it directly8descendants
  • K190085Journey II Unicompartmental Knee SystemSmith & Nephew, Inc. · 2019 · 2 generations on7descendants
  • K152726JOURNEY II XR Knee SystemSmith & Nephew, Inc. · 2015 · cites it directly4descendants
  • K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…Smith & Nephew, Inc. · 2023 · 2 generations on3descendants
  • K191211JOURNEY II Unicompartmental Knee SystemSmith & Nephew, Inc. · 2019 · 3 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−7K951987Genesis II Total Knee SystemSmith & Nephew Richards, Inc.19956
−6K030612Genesis II Total Knee SystemSmith & Nephew, Inc.2003—
−5K032295Genesis II Posterior Stabilized High Flexion Articular InsertSmith & Nephew, Inc.20036
−4K041825Smith & Nephew Genesis II Deep Flexion Cruciate Retaining Articular InsertSmith & Nephew, Inc.2005—
−3K071071Crosslinked Polyethylene Articular InsertsSmith & Nephew, Inc.20075
−2K111711Journey II BCS Knee SystemSmith & Nephew, Inc.20113
−1K121443Journey II CR Knee SystemSmith & Nephew, Inc.2012—
0 (this device)K141471Journey II XR Knee SystemSmith & Nephew, Inc.2014—
+1K152315JOURNEY II Uni Tibial Base and InsertSmith & Nephew, Inc.2015—
+2K190085Journey II Unicompartmental Knee SystemSmith & Nephew, Inc.20193
+1K152726JOURNEY II XR Knee SystemSmith & Nephew, Inc.2015—
+2K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System…Smith & Nephew, Inc.20231
+3K191211JOURNEY II Unicompartmental Knee SystemSmith & Nephew, Inc.2019—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199110
199420
199510
199640
199910
200210
200410
200510
200610
200710
200910
201010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201520
201710
201920
202010
202210
202310
202430
202610
FIG. 1 — Lineage of K141471, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K221479 Persona Personalized Knee Systemscore 22.4 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (4)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K904448Townley Total Knee (TTK)
Summary page 5
…Genesis II CR Reviewed Knee System Knee (BioPro) Flex Inserts 510(k) Number Subject 510(k) K904448 K121443 K951987 K041825 Smith & Smith & S…
Biopro, Inc.1991—
*K121443Journey II CR Knee System
Summary page 5
…nesis II CR Reviewed Knee System Knee (BioPro) Flex Inserts 510(k) Number Subject 510(k) K904448 K121443 K951987 K041825 Smith & Smith & Smith & S…
Smith & Nephew, Inc.2012—
*K951987Genesis II Total Knee System
Summary page 5
…d Knee System Knee (BioPro) Flex Inserts 510(k) Number Subject 510(k) K904448 K121443 K951987 K041825 Smith & Smith & Smith & Smith & Manufacturer…
Smith & Nephew Richards, Inc.19956
*K041825Smith & Nephew Genesis II Deep Flexion Cruciate Retaining Articular Insert
Summary page 5
…tem Knee (BioPro) Flex Inserts 510(k) Number Subject 510(k) K904448 K121443 K951987 K041825 Smith & Smith & Smith & Smith & Manufacturer…
Smith & Nephew, Inc.2005—

Also cleared against K904448: 5 other devices →

What descends from it? (12)

See all 12

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

NumberDeviceApplicantDecidedDescendants
K152315JOURNEY II Uni Tibial Base and InsertSmith & Nephew, Inc.20158
K152726JOURNEY II XR Knee SystemSmith & Nephew, Inc.20154
K173331JOURNEY II XR Knee InstrumentsSmith & Nephew, Inc.20171

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 19 years and passes through 2 companies; a new generation was cleared every 2.3 years on median.
  • 13 of the 23 ancestors have a recall of any class.
  • Of its descendants, K152315 (Smith & Nephew, Inc., 2015) has gone furthest, with 8 descendants of its own.
  • 5 other devices also cite its predicate K904448.

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

2007: 182008: 172009: 112010: 192011: 252012: 332013: 312014: 332015: 272016: 182017: 252018: 252019: 282020: 222021: 242022: 172023: 202024: 192025: 202026 (partial year): 12
2007high 33 (2012) · low 11 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JWH

55in 2025

2007: 74 days median2008: 81 days median2009: 168 days median2010: 85 days median2011: 87 days median2012: 85 days median2013: 128 days median2014: 98 days median2015: 87 days median2016: 88 days median2017: 118 days median2018: 90 days median2019: 133 days median2020: 59 days median2021: 61 days median2022: 56 days median2023: 57 days median2024: 89 days median2025: 55 days median2026 (partial year): 63 days median
2007high 168 (2009) · low 55 (2025)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JWH

2in 2025

2007: 142008: 102009: 1092010: 322011: 272012: 852013: 312014: 132015: 112016: 172017: 612018: 142019: 52020: 22021: 82022: 122023: 672024: 72025: 22026 (partial year): 4
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

2007: 1,3052008: 1,4832009: 1,8702010: 3,2862011: 5,1332012: 5,2032013: 6,1352014: 6,7222015: 6,8812016: 7,5862017: 12,2632018: 14,0712019: 14,9872020: 12,5922021: 9,4082022: 8,3642023: 8,9472024: 10,8282025: 9,306
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071874141,305
20081781101,483
2009111681091,870
20101985323,286
20112587275,133
20123385855,203
201331128316,135
20143398136,722
20152787116,881
20161888177,586
2017251186112,263
201825901414,071
201928133514,987
20202259212,592
2021246189,408
20221756128,364
20232057678,947
20241989710,828
2025205529,306
202612634—

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.

The Journey II Total Knee system components are indicated for use only with cement and are single use devices.

Indications for use as stated in the FDA summary.

Also cleared against K904448

5 other devices cite the same predicate.

  • K153657Vanguard XP Knee SystemBiomet, Inc. · 20161 recall
  • K143635KINETIS Total Knee SystemMako Surgical · 2015
  • K141407Vanguard XP Femoral Component (Gen II)/Vanguard XP Femoral TrialBiomet, Inc. · 20141 recall
  • K132873Vanguard XP Knee SystemBiomet, Inc. · 201322 recalls
  • K122160Vanguard XP Knee SystemBiomet Manufacturing Corp · 201312 recalls

More from Smith & Nephew, Inc.

692 FDA decisions under this applicant name. See the company

  • K263348Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one ULTRABRAID Suture, Blue; Q-FIX KNOTLESS All-Suture Anchor…Smith & Nephew, Inc. · 2026
  • K261462LANDMARK Total Knee SystemSmith & Nephew, Inc. · 2026
  • K261968Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981)…Smith & Nephew, Inc. · 2026
  • DEN250037TESSA Spatial Surgery System; INTELLIO Tablet (72205455)Smith & Nephew, Inc. · 2026
  • K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc. · 2026

Recent decisions in JWH

The JWH category page

  • K262057GMK ExtensionMedacta International SA · 2026
  • K260063GSPE SpacerThe General Hospital Corporation, d/b/a Massachusetts · 2026
  • K262293EVOLUTION MPX™ Total Knee SystemSuzhou Microport Orthorecon Co., Ltd. · 2026
  • K262341b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem…B-One Ortho, Corp. · 2026
  • K262130ATTUNE Revision Knee SystemDepuy Orthopaedics, Inc. · 2026

https://510kreport.com/device/K141471 · printed Nov 6, 2026

Cite this page

510(k) Report. “K141471: Journey II XR 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/K141471

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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