510(k) Report

510(k) · Cleared

Cleared

ANTHEM CR Total Knee System

K170648510(k) TraditionalCleared May 11, 201769-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 May 11, 2017 as substantially equivalent to K142807 (Smith & Nephew, Inc., 2014) and 3 other predicates after a 69-day review. Its family tree reaches back 8 generations to 1995. 4 later devices descend from it.

Decided
May 11, 2017
Review
69 days
Class
Class II
Product code
JWH
Recalls
None
Predicates
4

Its longest line of descent runs back 8 generations to K951987 (1995). 13 ancestors in all. 4 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1996: 3 other ancestors1999: 1 other ancestor2005: 1 other ancestor2023: 1 descendant cleared2024: 2 descendants 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 · recalledK093746 · Verilast Wear Claims for the Legion Primary Knee System · Smith & Nephew, Inc. · 2010K112941 · Legion Narrow Oxinium Cruciate Retaining and Posterior Stabilized Fenoral Components · Smith & Nephew, Inc. · 2011 · recalledK142807 · ANTHEM PS Total Knee System · Smith & Nephew, Inc. · 20141995200020052010201520202025
Other ancestors, by generationDescendants, by generation 2 generations back: 2 other ancestors3 generations back: 1 other ancestor4 generations back: 2 other ancestors 1 generation forward: 1 descendant2 generations forward: 3 descendants K142807 · ANTHEM PS Total Knee System · Smith & Nephew, Inc. · 2014K112941 · Legion Narrow Oxinium Cruciate Retaining and Posterior Stabilized Fenoral Components · Smith & Nephew, Inc. · 2011 · recalledK093746 · Verilast Wear Claims for the Legion Primary Knee System · Smith & Nephew, Inc. · 2010K071071 · 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 · 8 generations backK951987 Genesis II Total Knee SystemSmith & Nephew Richards, Inc. · 1995 · Recalled
  2. 7 generations backK030612 Genesis II Total Knee SystemSmith & Nephew, Inc. · 2003
  3. 6 generations backK032295 Genesis II Posterior Stabilized High Flexion Articular InsertSmith & Nephew, Inc. · 2003 · Recalled
  4. 5 generations backK041825 Smith & Nephew Genesis II Deep Flexion Cruciate Retaining Articular…Smith & Nephew, Inc. · 2005
  5. 4 generations backK071071 Crosslinked Polyethylene Articular InsertsSmith & Nephew, Inc. · 2007 · Recalled
  6. 3 generations backK093746 Verilast Wear Claims for the Legion Primary Knee SystemSmith & Nephew, Inc. · 2010
  7. 2 generations backK112941 Legion Narrow Oxinium Cruciate Retaining and Posterior Stabilized…Smith & Nephew, Inc. · 2011 · Recalled
  8. 1 generation backK142807 ANTHEM PS Total Knee SystemSmith & Nephew, Inc. · 2014
  9. This deviceK170648 ANTHEM CR Total Knee SystemSmith & Nephew, Inc. · 2017
  10. Descendant · cites it directly · 3 of its ownK230653 Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee…Smith & Nephew, Inc. · 2023 · Recalled
  11. Descendant · 2 generations on · 0 of its ownK261462 LANDMARK Total Knee SystemSmith & Nephew, Inc. · 2026
  12. Descendant · 2 generations on · 0 of its ownK241260 ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc. · 2024
  13. Descendant · 2 generations on · 0 of its ownK242711 JOURNEY II Unicompartmental Knee System (JOURNEY II UK)Smith & Nephew, Inc. · 2024

Most influential descendants

Showing 4 of 4 · See all
  • K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…Smith & Nephew, Inc. · 2023 · cites it directly3descendants
  • K261462LANDMARK Total Knee SystemSmith & Nephew, Inc. · 2026 · 2 generations on0descendants
  • K241260ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc. · 2024 · 2 generations on0descendants
  • K242711JOURNEY II Unicompartmental Knee System (JOURNEY II UK)Smith & Nephew, Inc. · 2024 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−8K951987Genesis II Total Knee SystemSmith & Nephew Richards, Inc.19956
−7K030612Genesis II Total Knee SystemSmith & Nephew, Inc.2003—
−6K032295Genesis II Posterior Stabilized High Flexion Articular InsertSmith & Nephew, Inc.20036
−5K041825Smith & Nephew Genesis II Deep Flexion Cruciate Retaining Articular InsertSmith & Nephew, Inc.2005—
−4K071071Crosslinked Polyethylene Articular InsertsSmith & Nephew, Inc.20075
−3K093746Verilast Wear Claims for the Legion Primary Knee SystemSmith & Nephew, Inc.2010—
−2K112941Legion Narrow Oxinium Cruciate Retaining and Posterior Stabilized Fenoral…Smith & Nephew, Inc.20113
−1K142807ANTHEM PS Total Knee SystemSmith & Nephew, Inc.2014—
0 (this device)K170648ANTHEM CR Total Knee SystemSmith & Nephew, Inc.2017—
+1K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System…Smith & Nephew, Inc.20231
+2K261462LANDMARK Total Knee SystemSmith & Nephew, Inc.2026—
+2K241260ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc.2024—
+2K242711JOURNEY II Unicompartmental Knee System (JOURNEY II UK)Smith & Nephew, Inc.2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199630
199910
200510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202310
202420
202610
FIG. 1 — Lineage of K170648, 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
*K142807ANTHEM PS Total Knee System
Summary page 4
…eight polyethylene (UHWMPE, ASTM F648) and sterilized via ethylene oxide (ETO). The existing GENESIS II Patellas (sizes: 26 – 35mm; K951987) and ANTHEM Tibia Baseplates (K142807) are used in conjunction with the new femoral to complete the ANTHEM CR Total Knee System. The GENESIS II CR Deep Flexion Inserts…
Smith & Nephew, Inc.2014—
*K112941Legion Narrow Oxinium Cruciate Retaining and Posterior Stabilized Fenoral Components
Summary page 5
…K170648 - Page 2 of 2 The new femoral components of the ANTHEM CR Total Knee System leverage established marketed designs (LEGION Narrow – K112941; GENESIS II – K951987) with some changes to accommodate varied patient anatomy. All of the implants are either gamma or ETO steri…
Smith & Nephew, Inc.20113
*K041825Smith & Nephew Genesis II Deep Flexion Cruciate Retaining Articular Insert
Summary page 4
…ML width of the posterior condyles than the standard options of the same size. Additionally, a range of Genesis II CR Deep Flex Inserts (sizes 1-8; thicknesses 9-18mm – K041825) have been rebranded as Anthem CR HF Inserts to provide consistency within the total knee system. Both the Genesis II CR HF and A…
Smith & Nephew, Inc.2005—
*K951987Genesis II Total Knee System
Summary page 4
…devices made of ultra-high molecular weight polyethylene (UHWMPE, ASTM F648) and sterilized via ethylene oxide (ETO). The existing GENESIS II Patellas (sizes: 26 – 35mm; K951987) and ANTHEM Tibia Baseplates (K142807) are used in conjunction with the new femoral to complete the ANTHEM CR Total Knee System.…
Smith & Nephew Richards, Inc.19956

Also cleared against K142807: 3 other devices →

What descends from it? (4)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…Smith & Nephew, Inc.20233

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 22 years and passes through 2 companies; a new generation was cleared every 2.5 years on median.
  • 8 of the 13 ancestors have a recall of any class.
  • Of its descendants, K230653 (Smith & Nephew, Inc., 2023) has gone furthest, with 3 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. 2017, 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.

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 K142807

3 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
  • K230555Cemented Tibia Baseplate no Taper with JRNY LockSmith & Nephew, Inc. · 2023
  • K150241Genesis II XLPE Resurfacing Patellar ComponentsSmith & Nephew, Inc. · 2015

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/K170648 · printed Nov 6, 2026

Cite this page

510(k) Report. “K170648: ANTHEM CR 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/K170648

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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