510(k) Report

510(k) · Cleared

Recalled · Class II · 2023

Journey II BCS Knee System

K111711510(k) AbbreviatedCleared Sep 16, 201188-day reviewClass II21 CFR 888.3560Recalls 3

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 Sep 16, 2011 as substantially equivalent to K042515 (Smith & Nephew, Inc., 2005) and 5 other predicates after an 88-day review. Its family tree reaches back 5 generations to 1995. 40 later devices descend from it. It has been recalled 3 times.

Decided
Sep 16, 2011
Review
88 days
Class
Class II
Product code
JWH
Recalls
3
Predicates
6

Its longest line of descent runs back 5 generations to K951987 (1995). 12 ancestors in all. 40 later devices descend from it, 7 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2009: 1 other ancestor2007: 1 other ancestor2005: 1 other ancestor1999: 1 other ancestor1996: 3 other ancestors2023: 4 descendants cleared2021: 4 descendants cleared2012: 2 descendants cleared2020: 4 descendants cleared2013: 1 descendant cleared2015: 5 descendants cleared2014: 1 descendant cleared2026: 2 descendants cleared2025: 4 descendants cleared2022: 4 descendants cleared2024: 5 descendants cleared2017: 1 descendant cleared2019: 3 descendants 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 · recalled1995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 4 other ancestors 1 generation forward: 7 descendants2 generations forward: 7 descendants3 generations forward: 8 descendants4 generations forward: 7 descendants5 generations forward: 7 descendants6 generations forward: 3 descendants7 generations forward: 1 descendant K071071 · 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+5
  1. Root · 5 generations backK951987 Genesis II Total Knee SystemSmith & Nephew Richards, Inc. · 1995 · Recalled
  2. 4 generations backK030612 Genesis II Total Knee SystemSmith & Nephew, Inc. · 2003
  3. 3 generations backK032295 Genesis II Posterior Stabilized High Flexion Articular InsertSmith & Nephew, Inc. · 2003 · Recalled
  4. 2 generations backK041825 Smith & Nephew Genesis II Deep Flexion Cruciate Retaining Articular…Smith & Nephew, Inc. · 2005
  5. 1 generation backK071071 Crosslinked Polyethylene Articular InsertsSmith & Nephew, Inc. · 2007 · Recalled
  6. This deviceK111711 Journey II BCS Knee SystemSmith & Nephew, Inc. · 2011
  7. Descendant · cites it directly · 37 of its ownK121443 Journey II CR Knee SystemSmith & Nephew, Inc. · 2012
  8. Descendant · 2 generations on · 18 of its ownK141934 Physica KR Knee SystemLima Corporate S.P.A. · 2015
  9. Descendant · 2 generations on · 12 of its ownK141471 Journey II XR Knee SystemSmith & Nephew, Inc. · 2014
  10. Descendant · 3 generations on · 8 of its ownK190911 Physica KR Liner and SMR Reverse Humeral LinerLimacorporate · 2019
  11. Descendant · 3 generations on · 8 of its ownK152315 JOURNEY II Uni Tibial Base and InsertSmith & Nephew, Inc. · 2015

Showing 5 of 40 descendants. See all descendants

Descendants cleared per year

2012: 22013: 12014: 12015: 52017: 12019: 32020: 42021: 42022: 42023: 42024: 52025: 42026: 2
2012high 5 (2015) · low 0 (2016)2026

Most influential descendants

Showing 5 of 40 · 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

GenerationNumberDeviceApplicantDecidedRecalls
−5K951987Genesis II Total Knee SystemSmith & Nephew Richards, Inc.19956
−4K030612Genesis II Total Knee SystemSmith & Nephew, Inc.2003—
−3K032295Genesis II Posterior Stabilized High Flexion Articular InsertSmith & Nephew, Inc.20036
−2K041825Smith & Nephew Genesis II Deep Flexion Cruciate Retaining Articular InsertSmith & Nephew, Inc.2005—
−1K071071Crosslinked Polyethylene Articular InsertsSmith & Nephew, Inc.20075
0 (this device)K111711Journey II BCS Knee SystemSmith & Nephew, Inc.2011—
+1K121443Journey II CR Knee SystemSmith & Nephew, Inc.2012—
+2K141934Physica KR Knee SystemLima Corporate S.P.A.2015—
+2K141471Journey II XR Knee SystemSmith & Nephew, Inc.2014—
+3K190911Physica KR Liner and SMR Reverse Humeral LinerLimacorporate2019—
+3K152315JOURNEY II Uni Tibial Base and InsertSmith & Nephew, Inc.2015—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199630
199910
200510
200710
200910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201220
201310
201410
201550
201710
201930
202040
202140
202240
202340
202450
202540
202620
FIG. 1 — Lineage of K111711, 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K042515Smith & Nephew, Inc. High Performance Knee
Summary page 1
…(UHMWPE) material. The Journey 11BCS Knee system will use existing cemented Journey tibia[ tray and patellar components currently used with the Journey BCS Knee System 1K042515) and may also be used with existing patellar components of the Genesis 11Knee System (K951 987). Technological Characteristics T…
Smith & Nephew, Inc.20053
*K073325Legion Porous Primary
Summary page 2
…Smith & Nephew, Inc -High Performance Knee System K042515 03/14/2005 Smith & Nephew, Inc Legion Porous Primary Knee .K073325 12/20/2007 System ______…
Smith & Nephew, Inc.2007—
*K071071Crosslinked Polyethylene Articular Inserts
Summary page 2
…System ______ _____ Smith & Nephew, Inc XLPE Articular Inserts K071071 09/19/2007 Smith & Nephew, Inc IGenesis 11Total Knee System K951987 08/22/1995_…
Smith & Nephew, Inc.20075
*K951987Genesis II Total Knee System
Summary page 1
…ay and patellar components currently used with the Journey BCS Knee System 1K042515) and may also be used with existing patellar components of the Genesis 11Knee System (K951 987). Technological Characteristics This 510(k) was prepared in accordance with the Agency's, "Draft Guidance for the Preparation of…
Smith & Nephew Richards, Inc.19956
*K032295Genesis II Posterior Stabilized High Flexion Articular Insert
Summary page 2
…ew, Inc IGenesis 11Total Knee System K951987 08/22/1995_ Smith & Nephew, Inc Genesis 11Posterior Stabilized High K032295 08/21/2003 _____________ I Flexion Articular Insert Smith & Nephew, Inc IJourney BCS Knee S…
Smith & Nephew, Inc.20036
*K091014Journey BCS Knee System
Summary page 2
…032295 08/21/2003 _____________ I Flexion Articular Insert Smith & Nephew, Inc IJourney BCS Knee System K091 014 0/920 Conclusion As previously noted, this Abbreviated 510(k) Premarket Notification is being submitted to request clearance…
Smith & Nephew, Inc.2009—

Also cleared against K042515: 11 other devices →

What descends from it? (40)

See all 40

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

NumberDeviceApplicantDecidedDescendants
K121443Journey II CR Knee SystemSmith & Nephew, Inc.201237
K113482Journey II Deep Dished Articular InsertsSmith & Nephew, Inc.20126
K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…Smith & Nephew, Inc.20233
K200407LEGION Inserts with JRNY LockSmith & Nephew, Inc.20202
K211671Journey II Mid-Level Tibial InsertsSmith & Nephew, Inc.20211
K230555Cemented Tibia Baseplate no Taper with JRNY LockSmith & Nephew, Inc.20230
K123692Pipeline Knee SystemPipeline Orthopedics20130

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

Recalls of this device

DateClassRecallRoot causeReason
Sep 27, 2023Class IIZ-0158-2024Component change controlThe 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, 2023Class IIZ-0157-2024Component change controlThe 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…
Apr 19, 2022Class IIZ-1099-2022Nonconforming Material/ComponentIt was reported that a JOURNEY II BCS Femoral OXIN LT SZ5 was in a box labelled as a LEGION NARROW PS OXIN SZ 6N RT.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 16 years and passes through 2 companies; a new generation was cleared every 2.5 years on median.
  • 7 of the 12 ancestors have a recall of any class.
  • Of its descendants, K121443 (Smith & Nephew, Inc., 2012) has gone furthest, with 37 descendants of its own.
  • 11 other devices also cite its predicate K042515.

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. 2011, 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. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact. Smith & Nephew, Inc. Journey 11BOS Knee 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 K042515

11 other devices cite the same predicate.

  • K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and II Knee Systems…Smith & Nephew, Inc. · 20231 recall
  • K221939Cemented Round Patella with JRNY PegsSmith & Nephew, Inc. · 2022
  • K211221Porous Patella and Porous Tibia BaseplateSmith & Nephew, Inc. · 2021
  • K152008Physica PS Knee SystemLima Corporate S.P.A. · 2015
  • K121393Smith & Nephew, Inc. Total Knee System InstrumentationSmith & Nephew, Inc. · 20124 recalls
  • K113482Journey II Deep Dished Articular InsertsSmith & Nephew, Inc. · 2012

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/K111711 · printed Nov 6, 2026

Cite this page

510(k) Report. “K111711: Journey II BCS 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/K111711

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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