510(k) Report

510(k) · Cleared

Recalled · Class II · 2023

Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and II Knee Systems, JOURNEY II CR Knee System, JOURNEY II Uni Knee System, Journey II UK Knee System, JOURNEY II XR Bi-Cruciate Retaining Knee System, JOURNEY PFJ System, JOURNEY Uni Knee System, Legion Hinge Total Knee System, Legion Total Knee System, ZUK Unicompartmental Knee System, ENGAGE Partial Knee System and Porous Patella and Porous Tibial Baseplates

K230653510(k) TraditionalCleared May 4, 202356-day reviewClass II21 CFR 888.3560Recalls 1

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 4, 2023 as substantially equivalent to K142807 (Smith & Nephew, Inc., 2014) and 33 other predicates after a 56-day review. Its family tree reaches back 12 generations to 1981. 3 later devices descend from it. It has been recalled once.

Decided
May 4, 2023
Review
56 days
Class
Class II
Product code
JWH
Recalls
1
Predicates
34

Its longest line of descent runs back 12 generations to K810258 (1981). 211 ancestors in all, the oldest K760245 (1976). 3 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2021: 1 other ancestor2019: 1 other ancestor2018: 1 other ancestor2017: 2 other ancestors2015: 3 other ancestors2014: 4 other ancestors2012: 3 other ancestors2011: 4 other ancestors2010: 6 other ancestors2009: 6 other ancestors2008: 9 other ancestors2007: 11 other ancestors2006: 9 other ancestors2005: 16 other ancestors2004: 13 other ancestors2003: 15 other ancestors1991: 4 other ancestors2013: 2 other ancestors2002: 11 other ancestors2001: 8 other ancestors1999: 4 other ancestors1996: 12 other ancestors1995: 10 other ancestors1988: 1 other ancestor1976: 1 other ancestor2000: 4 other ancestors1998: 4 other ancestors1997: 9 other ancestors1993: 3 other ancestors1989: 2 other ancestors1986: 1 other ancestor1994: 11 other ancestors1992: 3 other ancestors1990: 1 other ancestor1984: 1 other ancestor1987: 1 other ancestor1985: 1 other ancestor2024: 2 descendants cleared2026: 1 descendant clearedK810258 · Proximal Fermoral Hip Replacement · Biomet, Inc. · 1981K974558 · Salvage/Onocology Hip and Total Femur System · Biomet, Inc. · 1998K032396 · Ringloc 36MM Line and Modular Femoral Heads · Biomet, Inc. · 2003 · recalled×2: 2 generations cleared close together, K042051 (2005), K051411 (2005) K061312 · 36MM Biolox Delta Ceramic Heads · Biomet, Inc. · 2006K073102 · Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular Liners · Biomet Manufacturing Corp · 2007K100048 · E1 Antioxidant Infused Technology · Biomet Manufacturing Corp · 2010×2: 2 generations cleared close together, K120370 (2012), K122529 (2012) K160738 · ZUK Select Knee System · Smith & Nephew, Inc. · 2016K190085 · Journey II Unicompartmental Knee System · Smith & Nephew, Inc. · 2019 · recalled19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 32 other ancestors2 generations back: 31 other ancestors3 generations back: 43 other ancestors4 generations back: 39 other ancestors5 generations back: 26 other ancestors6 generations back: 22 other ancestors7 generations back: 5 other ancestors 1 generation forward: 3 descendants K190085 · Journey II Unicompartmental Knee System · Smith & Nephew, Inc. · 2019 · recalledK160738 · ZUK Select Knee System · Smith & Nephew, Inc. · 2016K122529 · Zimmer Unicompartmental Knee System Vivacit-E Articular Surface · Zimmer, Inc. · 2012K120370 · Vivacit-E Vitamin E Highly Crosslinked Polyethylene Liners · Zimmer, Inc. · 2012K100048 · E1 Antioxidant Infused Technology · Biomet Manufacturing Corp · 2010K073102 · Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular Liners · Biomet Manufacturing Corp · 2007K061312 · 36MM Biolox Delta Ceramic Heads · Biomet, Inc. · 2006K051411 · Arcomxl Polyethylene Liners and Biolox Delta Heads · Biomet, Inc. · 2005 · recalledK042051 · Arcomxl Polyethylene Liners · Biomet, Inc. · 2005 · recalledK032396 · Ringloc 36MM Line and Modular Femoral Heads · Biomet, Inc. · 2003 · recalledK974558 · Salvage/Onocology Hip and Total Femur System · Biomet, Inc. · 1998K810258 · Proximal Fermoral Hip Replacement · Biomet, Inc. · 1981−10−50
  1. Root · 12 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
  2. 8 generations between
  3. 3 generations backK122529 Zimmer Unicompartmental Knee System Vivacit-E Articular SurfaceZimmer, Inc. · 2012
  4. 2 generations backK160738 ZUK Select Knee SystemSmith & Nephew, Inc. · 2016
  5. 1 generation backK190085 Journey II Unicompartmental Knee SystemSmith & Nephew, Inc. · 2019 · Recalled
  6. This deviceK230653 Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee…Smith & Nephew, Inc. · 2023
  7. Descendant · cites it directly · 0 of its ownK261462 LANDMARK Total Knee SystemSmith & Nephew, Inc. · 2026
  8. Descendant · cites it directly · 0 of its ownK241260 ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc. · 2024
  9. Descendant · cites it directly · 0 of its ownK242711 JOURNEY II Unicompartmental Knee System (JOURNEY II UK)Smith & Nephew, Inc. · 2024
Show all 12 generations
  1. Root · 12 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
  2. 11 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
  3. 10 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
  4. 9 generations backK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
  5. 8 generations backK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
  6. 7 generations backK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
  7. 6 generations backK073102 Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular LinersBiomet Manufacturing Corp · 2007
  8. 5 generations backK100048 E1 Antioxidant Infused TechnologyBiomet Manufacturing Corp · 2010
  9. 4 generations backK120370 Vivacit-E Vitamin E Highly Crosslinked Polyethylene LinersZimmer, Inc. · 2012
  10. 3 generations backK122529 Zimmer Unicompartmental Knee System Vivacit-E Articular SurfaceZimmer, Inc. · 2012
  11. 2 generations backK160738 ZUK Select Knee SystemSmith & Nephew, Inc. · 2016
  12. 1 generation backK190085 Journey II Unicompartmental Knee SystemSmith & Nephew, Inc. · 2019 · Recalled
  13. This deviceK230653 Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee…Smith & Nephew, Inc. · 2023

Most influential descendants

Showing 3 of 3 · See all
  • K261462LANDMARK Total Knee SystemSmith & Nephew, Inc. · 2026 · cites it directly0descendants
  • K241260ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc. · 2024 · cites it directly0descendants
  • K242711JOURNEY II Unicompartmental Knee System (JOURNEY II UK)Smith & Nephew, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−12K810258Proximal Fermoral Hip ReplacementBiomet, Inc.1981—
−11K974558Salvage/Onocology Hip and Total Femur SystemBiomet, Inc.1998—
−10K032396Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc.20033
−9K042051Arcomxl Polyethylene LinersBiomet, Inc.20051
−8K051411Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc.20051
−7K06131236MM Biolox Delta Ceramic HeadsBiomet, Inc.2006—
−6K073102Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular LinersBiomet Manufacturing Corp2007—
−5K100048E1 Antioxidant Infused TechnologyBiomet Manufacturing Corp2010—
−4K120370Vivacit-E Vitamin E Highly Crosslinked Polyethylene LinersZimmer, Inc.2012—
−3K122529Zimmer Unicompartmental Knee System Vivacit-E Articular SurfaceZimmer, Inc.2012—
−2K160738ZUK Select Knee SystemSmith & Nephew, Inc.2016—
−1K190085Journey II Unicompartmental Knee SystemSmith & Nephew, Inc.20193
0 (this device)K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System…Smith & Nephew, Inc.2023—
+1K261462LANDMARK Total Knee SystemSmith & Nephew, Inc.2026—
+1K241260ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc.2024—
+1K242711JOURNEY II Unicompartmental Knee System (JOURNEY II UK)Smith & Nephew, Inc.2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197610
198410
198510
198610
198710
198810
198920
199010
199140
199230
199330
1994110
1995100
1996120
199790
199840
199940
200040
200180
2002110
2003150
2004130
2005160
200690
2007110
200890
200960
201060
201140
201230
201320
201440
201530
201720
201810
201910
202110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202420
202610
FIG. 1 — Lineage of K230653, 1981–2026Source: 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? (34)

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
*K142807ANTHEM PS Total Knee System
Summary page 24
…urer Description Number Date K142807 12/22/2014 Smith & Nephew,Inc. ANTHEM Total Knee System…
Smith & Nephew, Inc.2014—
*K170648ANTHEM CR Total Knee System
Summary page 24
…K142807 12/22/2014 Smith & Nephew,Inc. ANTHEM Total Knee System K170648 05/11/2017 K030301 02/25/2003 Smith & Nephew,Inc.…
Smith & Nephew, Inc.2017—
*K030301Unicondylar Femoral Component
Summary page 24
…HEM Total Knee System K170648 05/11/2017 K030301 02/25/2003 Smith & Nephew,Inc. Genesis Uni Knee System K…
Smith & Nephew, Inc.2003—
*K912735Genesis Unicompartmental Knee System
Summary page 24
…K030301 02/25/2003 Smith & Nephew,Inc. Genesis Uni Knee System K912735 12/27/1991 K042515 03/14/2005…
Smith & Nephew Richards, Inc.19912
*K042515Smith & Nephew, Inc. High Performance Knee
Summary page 24
…nesis Uni Knee System K912735 12/27/1991 K042515 03/14/2005 JOURNEY BCS and II Knee Smith & Nephew,Inc. K…
Smith & Nephew, Inc.20053
*K111711Journey II BCS Knee System
Summary page 24
…K042515 03/14/2005 JOURNEY BCS and II Knee Smith & Nephew,Inc. K111711 09/16/2011 Systems K140555…
Smith & Nephew, Inc.20113
*K140555Journey II BCS Constrained Inserts
Summary page 24
…phew,Inc. K111711 09/16/2011 Systems K140555 05/29/2014 K113482 02/27/2012 Smith & Nephew,Inc.…
Smith & Nephew, Inc.20142
*K113482Journey II Deep Dished Articular Inserts
Summary page 24
…Systems K140555 05/29/2014 K113482 02/27/2012 Smith & Nephew,Inc. JOURNEY II CR Knee System…
Smith & Nephew, Inc.2012—
*K121443Journey II CR Knee System
Summary page 24
…K113482 02/27/2012 Smith & Nephew,Inc. JOURNEY II CR Knee System K121443 08/13/2012 Smith & Nephew,Inc. JOURNEY II Uni Knee System K152315 10/28/2015 Smith & Nephew, Inc…
Smith & Nephew, Inc.2012—
*K152315JOURNEY II Uni Tibial Base and Insert
Summary page 24
…EY II CR Knee System K121443 08/13/2012 Smith & Nephew,Inc. JOURNEY II Uni Knee System K152315 10/28/2015 Smith & Nephew, Inc. JOURNEY II UK Knee System K190085 2/11/2019…
Smith & Nephew, Inc.2015—
*K190085Journey II Unicompartmental Knee System
Summary page 8
…PSC Publishing. Sm•1ces (301) 443�740 EF K190085 Page 1 of 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES Form Approved: OMB No. 09…
Smith & Nephew, Inc.20193
*K152726JOURNEY II XR Knee System
Summary page 24
…RNEY II UK Knee System K190085 2/11/2019 JOURNEY II XR Bi-Cruciate Smith & Nephew,Inc. K152726 10/21/2015 Retaining Knee System Smith & Nephew,Inc. JOURNEY PFJ System K05…
Smith & Nephew, Inc.2015—
*K051086Smith & Nephew Patello-Femoral Implant
Summary page 24
…K152726 10/21/2015 Retaining Knee System Smith & Nephew,Inc. JOURNEY PFJ System K051086 05/31/2005 K061011 07/11/2006…
Smith & Nephew, Inc.2005—
*K061011Competitor Unicondylar Knee Tibial Baseplate
Summary page 24
…etaining Knee System Smith & Nephew,Inc. JOURNEY PFJ System K051086 05/31/2005 K061011 07/11/2006 K061779 08/04/2006 Smith & Nephew,Inc.…
Smith & Nephew, Inc.2006—
*K061779Competitor Unicondylar All-Poly Tibial Baseplate
Summary page 24
…05/31/2005 K061011 07/11/2006 K061779 08/04/2006 Smith & Nephew,Inc. JOURNEY Uni Knee System K…
Smith & Nephew, Inc.2006—
*K073175Journey Unicondylar Femoral Implant
Summary page 24
…K061779 08/04/2006 Smith & Nephew,Inc. JOURNEY Uni Knee System K073175 12/20/2007 K102069 10/05/2010…
Smith & Nephew, Inc.2007—
*K102069Journey Unicondylar Tibial Baseplates
Summary page 24
…URNEY Uni Knee System K073175 12/20/2007 K102069 10/05/2010 K151118 07/28/2015 Smith & Nephew, Inc.…
Smith & Nephew, Inc.2010—
*K151118Smith and Nephew Legion Hinge Knee System
Summary page 24
…12/20/2007 K102069 10/05/2010 K151118 07/28/2015 Smith & Nephew, Inc. Legion Hinge Total Knee System…
Smith & Nephew2015—
*K081111Legion Hinge Knee System
Summary page 24
…K151118 07/28/2015 Smith & Nephew, Inc. Legion Hinge Total Knee System K081111 07/23/2008 6-8 === Page…
Smith & Nephew, Inc.20087
*K041106Revision Knee System
Summary page 25
…Description Number Date K041106 07/01/2004 K043440 02/18/2005…
Smith & Nephew, Inc.20041
*K043440Smith & Nephew, Inc. Revision Knee System
Summary page 25
…Date K041106 07/01/2004 K043440 02/18/2005 K060742 05/03/2006…
Smith & Nephew, Inc.20057
*K060742Legion Cobalt Chrome Revision Knee System
Summary page 25
…07/01/2004 K043440 02/18/2005 K060742 05/03/2006 K071071 09/19/2007…
Smith & Nephew, Inc.20063
*K071071Crosslinked Polyethylene Articular Inserts
Summary page 25
…02/18/2005 K060742 05/03/2006 K071071 09/19/2007 K072531 12/06/2007 Smith & Nephew,I…
Smith & Nephew, Inc.20075
*K072531Legion Stem with Holes
Summary page 25
…05/03/2006 K071071 09/19/2007 K072531 12/06/2007 Smith & Nephew,Inc. Legion Total Knee System K073325 12/20/2007…
Smith & Nephew, Inc.2007—
*K073325Legion Porous Primary
Summary page 25
…09/19/2007 K072531 12/06/2007 Smith & Nephew,Inc. Legion Total Knee System K073325 12/20/2007 K091543 12/21/2009…
Smith & Nephew, Inc.2007—
*K091543Legion Porous Plus HA Primary Femoral Components
Summary page 25
…12/06/2007 Smith & Nephew,Inc. Legion Total Knee System K073325 12/20/2007 K091543 12/21/2009 K100897 05/13/2010…
Smith & Nephew, Inc.2009—
*K100897Legion Porous + HA Tibial Baseplates
Summary page 25
…12/20/2007 K091543 12/21/2009 K100897 05/13/2010 K112941 12/20/2011…
Smith & Nephew, Inc.2010—
*K112941Legion Narrow Oxinium Cruciate Retaining and Posterior Stabilized Fenoral Components
Summary page 25
…12/21/2009 K100897 05/13/2010 K112941 12/20/2011 K162775 01/13/2017…
Smith & Nephew, Inc.20113
*K162775Legion Cone System
Summary page 25
…05/13/2010 K112941 12/20/2011 K162775 01/13/2017 K180334 03/05/2018…
Smith & Nephew, Inc.20172
*K180334LEGION Knee System
Summary page 25
…12/20/2011 K162775 01/13/2017 K180334 03/05/2018 ZUK Unicompartmental Knee K033363 01/16/2004 Smith & Nephew,…
Smith & Nephew, Inc.2018—
*K033363Zimmer Unicompartmental Knee System
Summary page 25
…01/13/2017 K180334 03/05/2018 ZUK Unicompartmental Knee K033363 01/16/2004 Smith & Nephew,Inc. System K122529 11/16/2…
Zimmer, Inc.20043
*K122529Zimmer Unicompartmental Knee System Vivacit-E Articular Surface
Summary page 25
…ZUK Unicompartmental Knee K033363 01/16/2004 Smith & Nephew,Inc. System K122529 11/16/2012 Smith & Nephew, Inc. ENGAGE Partial Knee System K190439 11/21…
Zimmer, Inc.2012—
*K190439Engage™ Partial Knee System
Summary page 25
…System K122529 11/16/2012 Smith & Nephew, Inc. ENGAGE Partial Knee System K190439 11/21/2019 Porous Patella and Porous Tibial Smith & Nephew, Inc.…
Engage Uni, LLC20194
*K211221Porous Patella and Porous Tibia Baseplate
Summary page 25
…Knee System K190439 11/21/2019 Porous Patella and Porous Tibial Smith & Nephew, Inc. K211221 10/01/2021 Baseplates Conclusion In summary, the only differences between the sub…
Smith & Nephew, Inc.2021—

Also cleared against K142807: 3 other devices →

What descends from it? (3)

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

NumberDeviceApplicantDecidedDescendants
K261462LANDMARK Total Knee SystemSmith & Nephew, Inc.20260
K241260ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc.20240
K242711JOURNEY II Unicompartmental Knee System (JOURNEY II UK)Smith & Nephew, Inc.20240

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

Recalls of this device

DateClassRecallRoot causeReason
Aug 31, 2023Class IIZ-2621-2023Labeling Change ControlThe firm conducting a recall due to a complaint received indicating that a package contained a LEGION NARROW PS OXIN SZ 4N LT implant instead of a LEGION NARROW PSvOXIN SZ 5N LT as described on the product label.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 42 years and passes through 4 companies; a new generation was cleared every 2.3 years on median.
  • 88 of the 210 ancestors have a recall of any class.
  • Of its descendants, K261462 (Smith & Nephew, Inc., 2026) has gone furthest, with 0 descendants of its own.
  • 3 other devices also cite its predicate K142807.

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. 2023, 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?

1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis. 3. Failed osteotomies, unicompartmental replacement, or total knee replacement. 4. 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. The ANTHEM PS Total Knee System is indicated for use only with…

Read the full statement (1,216 words)

1. Rheumatoid arthritis.

2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis.

3. Failed osteotomies, unicompartmental replacement, or total knee replacement.

4. 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.

The ANTHEM PS Total Knee System is indicated for use only with cement and is a single use device.

Unicompartmental knee implants are indicated for restoring either compartment of a knee that has been affected by the following:

1. Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;

2. Correction of functional deformity;

3. Revision procedures where other treatments or devices have failed; and

4. Treatment of fractures that are unmanageable using other techniques

Unicompartmental knee implants are single use only and are intended for implantation only with bone cement. HA coated unicompartmental knee implants are available outside the US for use without bone cement.

I. Rheumatoid arthritis.

2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis.

3. Failed osteotomies, unicompartmental replacement, or total knee replacement.

4. 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 II BCS Knee components are indicated for use only with cement and are single use devices.

1. Rheumatoid arthritis.

2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis.

3. Failed osteotomies, unicompartmental replacement, or total knee replacement.

4. 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.

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

Unicompartmental knee implants are indicated for restoring either compartment of a knee that has been affected by the following:

I. Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;

2. Correction of functional deformity;

3. Revision procedures where other treatments or devices have failed; and

4. Treatment of fractures that are unmanageable using other techniques

Unicompartmental knee implants are single use only and are intended for implantation only with bone cement. HA coated unicompartmental knee implants are available outside the US for use without bone cement.

Unicompartmental knee implants are indicated for restoring either compartment of a knee that has been affected by the following:

• Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;

• Correction of functional deformity;

• Revision procedures where other treatments or devices have failed; and

• Treatment of fractures that are unmanageable using other techniques.

Unicompartmental knee implants are single use only and are intended for implantation only with bone cement.

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.

1. Degenerative arthritis in the distal femur and patella;

2. A history of patellar dislocation or patellar fracture; and

3. Failed previous surgery (arthroplasty, tibial tubercule elevation, lateral release) where pain, deformity or dysfunction persists.

The Smith & Nephew Patello-Femoral Implants are intended for implantation with bone cement.

Unicompartmental knee implants are indicated for restoring either compartment of a knee that has been affected by the following:

l. Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;

2. Correction of functional deformity;

3. Revision procedures where other treatments or devices have failed; and

4. Treatment of fractures that are unmanageable using other techniques

Unicompartmental knee implants are single use only and are intended for implantation only with bone cement. HA coated unicompartmental knee implants are available outside the US for use without bone cement.

1. Rheumatoid arthritis.

2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis.

3. Failed osteotomies, unicompartmental replacement, or total knee replacement.

4. 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.

5. Constrained knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/or lateral collateral ligament) are incompetent.

6. Hinge knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/or lateral collateral ligament) are absent or incompetent.

The Legion Hinge Knee System is for Cemented Use Only.

1. Rheumatoid arthritis.

2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis.

3. Failed osteotomies, unicompartmental replacement, or total knee replacement.

4. 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.

5. Constrained knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/or lateral collateral ligament) are incompetent.

6. Hinge knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/or lateral collateral ligament) are absent or incompetent.

The LEGION Knee System - Finned Tibial Wedges are for single use only and are intended for implantation with bone cement.

These devices are indicated for patients with:

1. Painful and/or disabling knee joints due to osteoarthritis or traumatic arthritis.

2. Previous tibial condyle or plateu fractures with loss of anatomy or function.

3. Varus or Valgus deformities.

4. Revision of previous arthroplasty procedures.

The devices are indicated for cemented use only.

The Zimmer Unicompartmental Knee System is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees.

The Engage™ Partial Knee System is intended for medial unicompartmental knee arthroplasty to treat one or more of the following conditions:

- Moderately disabling joint disease of the knee resulting from painful osteo- or post traumatic arthritis.

- Revision of previous unsuccessful surgical procedures, including prior unicompartmental knee arthroplasty

- As an alternative to tibial osteotomy in patients with Unicompartmental osteoarthritis.

The femoral component and tibial tray are intended for cementless or cemented fixation. The porous surfaces of both the femoral and tibial tray components provide biological fixation when used in a cementless application. When the tibial tray is implanted without the use of bone cement, the tibial anchor should be used. When the tibial tray is implanted with bone cement, the tibial anchor should not be used.

Total knee components are indicated for:

1. Rheumatoid arthritis.

2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis.

3. Failed osteotomies, unicompartmental replacement, or total knee replacement.

4. The posterior-stabilized knee system is 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.

LEGION Porous CRNarrow Femoral Components are indicated for use without bone cement and are single use devices.

The Porous Patella and the Porous Tibia Baseplate are indicated for use with or without bone cement, and are single use devices.

Indications for use as stated in the FDA summary.

Also cleared against K142807

3 other devices cite the same predicate.

  • K230555Cemented Tibia Baseplate no Taper with JRNY LockSmith & Nephew, Inc. · 2023
  • K170648ANTHEM CR Total Knee SystemSmith & Nephew, Inc. · 2017
  • K150241Genesis II XLPE Resurfacing Patellar ComponentsSmith & Nephew, Inc. · 2015

More from Smith & Nephew, Inc.

692 FDA decisions under this applicant name. See the company

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The JWH category page

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  • K262341b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem…B-One Ortho, Corp. · 2026
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https://510kreport.com/device/K230653 · printed Nov 6, 2026

Cite this page

510(k) Report. “K230653: Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and II Knee Systems, JOURNEY II CR Knee System, JOURNEY II Uni Knee System, Journey II UK Knee System, JOURNEY II XR Bi-Cruciate Retaining Knee System, JOURNEY PFJ System, JOURNEY Uni Knee System, Legion Hinge Total Knee System, Legion Total Knee System, ZUK Unicompartmental Knee System, ENGAGE Partial Knee System and Porous Patella and Porous Tibial Baseplates.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230653

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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