510(k) Report

510(k) · Cleared

Cleared

LANDMARK Total Knee System

K261462510(k) TraditionalCleared Sep 8, 2026127-day reviewClass II21 CFR 888.3565

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Smith & Nephew, Inc. · MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer

Cleared on Sep 8, 2026 as substantially equivalent to K073325 (Smith & Nephew, Inc., 2007) and 5 other predicates after a 127-day review. Its family tree reaches back 13 generations to 1981.

Decided
Sep 8, 2026
Review
127 days
Class
Class II
Product code
MBH
Recalls
None
Predicates
6

Its longest line of descent runs back 13 generations to K810258 (1981). 212 ancestors in all, the oldest K760245 (1976). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2021: 1 other ancestor2012: 3 other ancestors2007: 11 other ancestors2003: 15 other ancestors1995: 10 other ancestors2019: 1 other ancestor2018: 1 other ancestor2017: 2 other ancestors2015: 3 other ancestors2014: 4 other ancestors2013: 2 other ancestors2011: 4 other ancestors2010: 6 other ancestors2009: 6 other ancestors2008: 9 other ancestors2006: 9 other ancestors2005: 16 other ancestors2004: 13 other ancestors1996: 12 other ancestors1991: 4 other ancestors2002: 11 other ancestors2001: 8 other ancestors1999: 4 other ancestors1988: 1 other ancestor1976: 1 other ancestor2000: 4 other ancestors1998: 4 other ancestors1997: 9 other ancestors1994: 11 other ancestors1993: 3 other ancestors1989: 2 other ancestors1986: 1 other ancestor1992: 3 other ancestors1990: 1 other ancestor1984: 1 other ancestor1987: 1 other ancestor1985: 1 other ancestorK810258 · 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 · recalledK230653 · 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 · Smith & Nephew, Inc. · 2023 · recalled19801990200020102020
Other ancestors, by generation 1 generation back: 5 other ancestors2 generations back: 32 other ancestors3 generations back: 33 other ancestors4 generations back: 43 other ancestors5 generations back: 35 other ancestors6 generations back: 25 other ancestors7 generations back: 20 other ancestors8 generations back: 5 other ancestors 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 · Smith & Nephew, Inc. · 2023 · recalledK190085 · 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 · 13 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
  2. 9 generations between
  3. 3 generations backK160738 ZUK Select Knee SystemSmith & Nephew, Inc. · 2016
  4. 2 generations backK190085 Journey II Unicompartmental Knee SystemSmith & Nephew, Inc. · 2019 · Recalled
  5. 1 generation backK230653 Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee…Smith & Nephew, Inc. · 2023 · Recalled
  6. This deviceK261462 LANDMARK Total Knee SystemSmith & Nephew, Inc. · 2026
Show all 13 generations
  1. Root · 13 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
  2. 12 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
  3. 11 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
  4. 10 generations backK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
  5. 9 generations backK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
  6. 8 generations backK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
  7. 7 generations backK073102 Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular LinersBiomet Manufacturing Corp · 2007
  8. 6 generations backK100048 E1 Antioxidant Infused TechnologyBiomet Manufacturing Corp · 2010
  9. 5 generations backK120370 Vivacit-E Vitamin E Highly Crosslinked Polyethylene LinersZimmer, Inc. · 2012
  10. 4 generations backK122529 Zimmer Unicompartmental Knee System Vivacit-E Articular SurfaceZimmer, Inc. · 2012
  11. 3 generations backK160738 ZUK Select Knee SystemSmith & Nephew, Inc. · 2016
  12. 2 generations backK190085 Journey II Unicompartmental Knee SystemSmith & Nephew, Inc. · 2019 · Recalled
  13. 1 generation backK230653 Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee…Smith & Nephew, Inc. · 2023 · Recalled
  14. This deviceK261462 LANDMARK Total Knee SystemSmith & Nephew, Inc. · 2026
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−13K810258Proximal Fermoral Hip ReplacementBiomet, Inc.1981—
−12K974558Salvage/Onocology Hip and Total Femur SystemBiomet, Inc.1998—
−11K032396Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc.20033
−10K042051Arcomxl Polyethylene LinersBiomet, Inc.20051
−9K051411Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc.20051
−8K06131236MM Biolox Delta Ceramic HeadsBiomet, Inc.2006—
−7K073102Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular LinersBiomet Manufacturing Corp2007—
−6K100048E1 Antioxidant Infused TechnologyBiomet Manufacturing Corp2010—
−5K120370Vivacit-E Vitamin E Highly Crosslinked Polyethylene LinersZimmer, Inc.2012—
−4K122529Zimmer Unicompartmental Knee System Vivacit-E Articular SurfaceZimmer, Inc.2012—
−3K160738ZUK Select Knee SystemSmith & Nephew, Inc.2016—
−2K190085Journey II Unicompartmental Knee SystemSmith & Nephew, Inc.20193
−1K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System…Smith & Nephew, Inc.20231
0 (this device)K261462LANDMARK Total Knee SystemSmith & Nephew, Inc.2026—

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
FIG. 1 — Lineage of K261462, 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 MBH? 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 MBH device

  1. #1 K241597 Freedom® Total Knee System - Porous Tibial…score 19.9 · 8 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
*K073325Legion Porous Primary
Summary page 5
…3565 Product Code(s) MBH, JWH I Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K073325, K230653 | | LEGION POROUS PRIMARY MBH K121443, K230653 | | JOURNEY Il CR KNEE SYSTEM JWH K951987, KO30612 | | GENESIS Il TOTAL K…
Smith & Nephew, Inc.2007—
*K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…
Summary page 5
…uct Code(s) MBH, JWH I Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K073325, K230653 | | LEGION POROUS PRIMARY MBH K121443, K230653 | | JOURNEY Il CR KNEE SYSTEM JWH K951987, KO30612 | | GENESIS Il TOTAL KNEE SYSTE…
Smith & Nephew, Inc.20231
*K121443Journey II CR Knee System
Summary page 5
…ed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K073325, K230653 | | LEGION POROUS PRIMARY MBH K121443, K230653 | | JOURNEY Il CR KNEE SYSTEM JWH K951987, KO30612 | | GENESIS Il TOTAL KNEE SYSTEM JWH, MBH K211221, K230653 Porous Pat…
Smith & Nephew, Inc.2012—
*K951987Genesis II Total Knee System
Summary page 5
…# Predicate Trade Name (Primary Predicate is listed first) Product Code K073325, K230653 | | LEGION POROUS PRIMARY MBH K121443, K230653 | | JOURNEY Il CR KNEE SYSTEM JWH K951987, KO30612 | | GENESIS Il TOTAL KNEE SYSTEM JWH, MBH K211221, K230653 Porous Patella and Porous Tibia Baseplate MBH, JWH Device Des…
Smith & Nephew Richards, Inc.19956
*K030612Genesis II Total Knee System
Summary page 6
…0/2007 & K230653, SE 05/04/2023), JOURNEY Il CR KNEE SYSTEM (K121443, SE 08/13/2012 & K230653, SE 05/04/2023), and GENESIS || TOTAL KNEE SYSTEM (K951987, SE 08/22/1995 & K030612, SE 05/27/2003). The primary predicate LEGION POROUS PRIMARY is indicated for use without bone cement however the subject device…
Smith & Nephew, Inc.2003—
*K211221Porous Patella and Porous Tibia Baseplate
Summary page 5
…Product Code K073325, K230653 | | LEGION POROUS PRIMARY MBH K121443, K230653 | | JOURNEY Il CR KNEE SYSTEM JWH K951987, KO30612 | | GENESIS Il TOTAL KNEE SYSTEM JWH, MBH K211221, K230653 Porous Patella and Porous Tibia Baseplate MBH, JWH Device Description Summary 21 CFR 807.92(a)(4) The device in scope o…
Smith & Nephew, Inc.2021—

Also cleared against K073325: 5 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 45 years and passes through 4 companies; a new generation was cleared every 2.3 years on median.
  • 89 of the 211 ancestors have a recall of any class.
  • 5 other devices also cite its predicate K073325.

How does its category compare?

All MBH devices

MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.

FDA decisions per year · MBH

8in 2025

2007: 102008: 32009: 32010: 42011: 52012: 52013: 62014: 92015: 82016: 42017: 42018: 62019: 12020: 72021: 62022: 72023: 62024: 102025: 82026 (partial year): 7
2007high 10 (2007) · low 1 (2019)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MBH

98in 2025

2007: 59 days median2008: 70 days median2009: 209 days median2010: 84 days median2011: 84 days median2012: 90 days median2013: 138 days median2014: 114 days median2015: 100 days median2016: 74 days median2017: 115 days median2018: 89 days median2020: 112 days median2021: 48 days median2022: 57 days median2023: 94 days median2024: 84 days median2025: 98 days median2026 (partial year): 153 days median
2007high 209 (2009) · low 48 (2021)2026

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

Recalls per year · MBH

1in 2024

2009: 22011: 152012: 1, 1 Class I2013: 4, 4 Class I2016: 12017: 92018: 12019: 12020: 22023: 22024: 12026 (partial year): 4
2007high 15 (2011) · low 0 (2007)2026

Class I (5 since 2007) Class II/III not classified

Adverse event reports per year · MBH

1,561in 2025

2007: 272008: 212009: 892010: 1212011: 2472012: 3702013: 3082014: 3852015: 9552016: 1,0342017: 1,0072018: 1,1912019: 1,3942020: 1,0892021: 1,5392022: 1,2612023: 1,2632024: 1,4972025: 1,561
2007high 1,561 (2025) · low 21 (2008)2025

MAUDE reports naming product code MBH, 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
20071059027
2008370021
20093209289
20104840121
201158415247
20125901 (1)370
201361384 (4)308
201491140385
201581000955
201647411,034
2017411591,007
201868911,191
20191—11,394
2020711221,089
202164801,539
202275701,261
202369421,263
2024108411,497
202589801,561
202671534—

What is it indicated for?

The Smith & Nephew LANDMARK Total Knee System is intended for total knee arthroplasty in skeletally mature patients. The LANDMARK CR Porous Femoral component is intended for use with or without bone cement.

Indications for Use:

* Rheumatoid arthritis

* Post-traumatic arthritis, osteoarthritis, or degenerative arthritis

* Failed unicompartmental or total knee replacements

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K073325

5 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
  • K210566LEGION Porous CR Narrow Femoral ComponentsSmith & Nephew, Inc. · 2021
  • K121393Smith & Nephew, Inc. Total Knee System InstrumentationSmith & Nephew, Inc. · 20124 recalls
  • K111711Journey II BCS Knee SystemSmith & Nephew, Inc. · 20113 recalls
  • K091543Legion Porous Plus HA Primary Femoral ComponentsSmith & Nephew, Inc. · 2009

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
  • 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
  • P000057/S013Ascension MCPSmith & Nephew, Inc. · 2025

Recent decisions in MBH

The MBH category page

  • K261275Unity Total Knee System, Unity Knee Cementless CR FemurCorin, Ltd. · 2026
  • K253728EVOLUTION® AM BIOFOAM® Tibial SystemMicroport Orthopedics, Inc. · 2026
  • K251840Zimmer® Persona® Personalized Knee SystemZimmer, Inc. · 2026
  • K253189Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)Zimmer, Inc. · 2026
  • K253328GMK 3D Metal Tibial Tray ExtensionMedacta International S.A. · 2026

https://510kreport.com/device/K261462 · printed Nov 6, 2026

Cite this page

510(k) Report. “K261462: LANDMARK Total 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/K261462

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Record history
  • FDA decision record loaded Oct 30, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026