510(k) Report

510(k) · Cleared

Cleared

iTotal Identity Cruciate Retaining Knee Replacement System

K190562510(k) TraditionalCleared Aug 8, 2019156-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

Conformis, Inc. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Cleared on Aug 8, 2019 as substantially equivalent to K180906 (Conformis, Inc., 2018) and 2 other predicates after a 156-day review. Its family tree reaches back 16 generations to 1981. 15 later devices descend from it.

Decided
Aug 8, 2019
Review
156 days
Class
Class II
Product code
JWH
Recalls
None
Predicates
3

Its longest line of descent runs back 16 generations to K810258 (1981). 151 ancestors in all. 15 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2018: 1 other ancestor2016: 3 other ancestors2015: 3 other ancestors2014: 3 other ancestors2012: 8 other ancestors2009: 1 other ancestor2007: 4 other ancestors2006: 4 other ancestors2000: 6 other ancestors1996: 6 other ancestors1995: 13 other ancestors1993: 6 other ancestors1991: 4 other ancestors2011: 3 other ancestors2010: 3 other ancestors2005: 5 other ancestors2004: 7 other ancestors2003: 5 other ancestors2002: 6 other ancestors1997: 8 other ancestors1994: 9 other ancestors1987: 2 other ancestors1985: 1 other ancestor2013: 1 other ancestor2001: 6 other ancestors2008: 3 other ancestors1999: 2 other ancestors1998: 3 other ancestors1992: 5 other ancestors1990: 1 other ancestor1984: 1 other ancestor1981: 1 other ancestor1988: 1 other ancestor2021: 5 descendants cleared2020: 2 descendants cleared2023: 5 descendants cleared2022: 2 descendants cleared2025: 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 · recalledK050327 · E-Poly (Vitamin E) Acetabular Liners · Biomet, Inc. · 2005K070364 · 100KGY E-Poly Maxrom Acetabular Liners · Biomet, Inc. · 2007K080528 · E-Poly Tibial Bearings · Biomet Orthopedics, Inc. · 2008×2: 2 generations cleared close together, K091956 (2010), K103223 (2010) ×2: 2 generations cleared close together, K122870 (2013), K131019 (2013) ×2: 2 generations cleared close together, K140423 (2014), K142161 (2014) ×3: 3 generations cleared close together, K152704 (2015), K160025 (2016), K161366 (2016) K180906 · Conformis iTotal Cruciate Retaining (CR) Knee Replacement System · Conformis, Inc. · 2018 · recalled19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 7 other ancestors3 generations back: 11 other ancestors4 generations back: 26 other ancestors5 generations back: 19 other ancestors6 generations back: 34 other ancestors7 generations back: 19 other ancestors8 generations back: 16 other ancestors9 generations back: 1 other ancestor 1 generation forward: 4 descendants2 generations forward: 3 descendants3 generations forward: 3 descendants4 generations forward: 3 descendants5 generations forward: 2 descendants K180906 · Conformis iTotal Cruciate Retaining (CR) Knee Replacement System · Conformis, Inc. · 2018 · recalledK161366 · ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS) · Conformis, Inc. · 2016K160025 · iTotal Posterior Stabilized (PS) Knee Replacement System, iTotal Cruciate Retaining (CR) Knee Replacement System · Conformis, Inc. · 2016 · recalledK152704 · iTotal Posterior Stabilized Knee Replacement System, iTotal Cruciate Retaining Knee Replacement System · Conformis, Inc. · 2015K142161 · Itotal Cruciate Retaining (CR) Knee Replacement System, Itotal Posterior Stabilized (PS) Knee Replacement System · Conformis, Inc. · 2014 · recalledK140423 · Itotal Cruciate Retaining (CR) Knee Replacement System · Conformis, Inc. · 2014 · recalledK131019 · Itotal Cruciate Retaining (C) Knee Replacement System · Conformis, Inc. · 2013K122870 · Itotal Cruciate Retaining (CR) Knee Replacement System · Conformis, Inc. · 2013K103223 · Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts · Encore Medical L.P. · 2010K091956 · Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model 391/392-09_19-702_712 · Encore Medical L.P. · 2010 · recalledK080528 · E-Poly Tibial Bearings · Biomet Orthopedics, Inc. · 2008K070364 · 100KGY E-Poly Maxrom Acetabular Liners · Biomet, Inc. · 2007K050327 · E-Poly (Vitamin E) Acetabular Liners · Biomet, Inc. · 2005K032396 · 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. · 1981−15−10−50+5
  1. Root · 16 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
  2. 12 generations between
  3. 3 generations backK160025 iTotal Posterior Stabilized (PS) Knee Replacement System, iTotal…Conformis, Inc. · 2016 · Recalled
  4. 2 generations backK161366 ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System…Conformis, Inc. · 2016
  5. 1 generation backK180906 Conformis iTotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 2018 · Recalled
  6. This deviceK190562 iTotal Identity Cruciate Retaining Knee Replacement SystemConformis, Inc. · 2019
  7. Descendant · cites it directly · 14 of its ownK201023 iTotal® Identity Posterior Stabilized Knee Replacement SystemConformis, Inc. · 2020
  8. Descendant · cites it directly · 12 of its ownK203447 iTotal Identity Cruciate Retaining (CR) Total Knee Replacement…Conformis, Inc. · 2020
  9. Descendant · cites it directly · 10 of its ownK210191 Identity Imprint Knee Replacement SystemConformis, Inc. · 2021 · Recalled
  10. Descendant · cites it directly · 9 of its ownK212411 Identity Imprint Knee Replacement System (including Identity Imprint…Conformis, Inc. · 2021
  11. Descendant · 2 generations on · 8 of its ownK213389 Identity Imprint Cruciate Retaining (CR) Knee Replacement System and…Conformis, Inc. · 2021
Show all 16 generations
  1. Root · 16 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
  2. 15 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
  3. 14 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
  4. 13 generations backK050327 E-Poly (Vitamin E) Acetabular LinersBiomet, Inc. · 2005
  5. 12 generations backK070364 100KGY E-Poly Maxrom Acetabular LinersBiomet, Inc. · 2007
  6. 11 generations backK080528 E-Poly Tibial BearingsBiomet Orthopedics, Inc. · 2008
  7. 10 generations backK091956 Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model…Encore Medical L.P. · 2010 · Recalled
  8. 9 generations backK103223 Highly Cross-Linked Vitamin E Uhmwpe Tibial InsertsEncore Medical L.P. · 2010
  9. 8 generations backK122870 Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 2013
  10. 7 generations backK131019 Itotal Cruciate Retaining (C) Knee Replacement SystemConformis, Inc. · 2013
  11. 6 generations backK140423 Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 2014 · Recalled
  12. 5 generations backK142161 Itotal Cruciate Retaining (CR) Knee Replacement System, Itotal…Conformis, Inc. · 2014 · Recalled
  13. 4 generations backK152704 iTotal Posterior Stabilized Knee Replacement System, iTotal Cruciate…Conformis, Inc. · 2015
  14. 3 generations backK160025 iTotal Posterior Stabilized (PS) Knee Replacement System, iTotal…Conformis, Inc. · 2016 · Recalled
  15. 2 generations backK161366 ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System…Conformis, Inc. · 2016
  16. 1 generation backK180906 Conformis iTotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 2018 · Recalled
  17. This deviceK190562 iTotal Identity Cruciate Retaining Knee Replacement SystemConformis, Inc. · 2019

Showing 5 of 15 descendants. See all descendants

Descendants cleared per year

2020: 22021: 52022: 22023: 52025: 1
2020high 5 (2021) · low 0 (2024)2026

Most influential descendants

Showing 5 of 15 · See all
  • K201023iTotal® Identity Posterior Stabilized Knee Replacement SystemConformis, Inc. · 2020 · cites it directly14descendants
  • K203447iTotal Identity Cruciate Retaining (CR) Total Knee Replacement, iTotal Identity…Conformis, Inc. · 2020 · cites it directly12descendants
  • K210191Identity Imprint Knee Replacement SystemConformis, Inc. · 2021 · cites it directly10descendants
  • K212411Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc. · 2021 · cites it directly9descendants
  • K213389Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint…Conformis, Inc. · 2021 · 2 generations on8descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−16K810258Proximal Fermoral Hip ReplacementBiomet, Inc.1981—
−15K974558Salvage/Onocology Hip and Total Femur SystemBiomet, Inc.1998—
−14K032396Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc.20033
−13K050327E-Poly (Vitamin E) Acetabular LinersBiomet, Inc.2005—
−12K070364100KGY E-Poly Maxrom Acetabular LinersBiomet, Inc.2007—
−11K080528E-Poly Tibial BearingsBiomet Orthopedics, Inc.2008—
−10K091956Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model 391/392-09_19-702_712Encore Medical L.P.20104
−9K103223Highly Cross-Linked Vitamin E Uhmwpe Tibial InsertsEncore Medical L.P.2010—
−8K122870Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.2013—
−7K131019Itotal Cruciate Retaining (C) Knee Replacement SystemConformis, Inc.2013—
−6K140423Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.20141
−5K142161Itotal Cruciate Retaining (CR) Knee Replacement System, Itotal Posterior…Conformis, Inc.20146
−4K152704iTotal Posterior Stabilized Knee Replacement System, iTotal Cruciate Retaining…Conformis, Inc.2015—
−3K160025iTotal Posterior Stabilized (PS) Knee Replacement System, iTotal Cruciate…Conformis, Inc.20161
−2K161366ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS)Conformis, Inc.2016—
−1K180906Conformis iTotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.20184
0 (this device)K190562iTotal Identity Cruciate Retaining Knee Replacement SystemConformis, Inc.2019—
+1K201023iTotal® Identity Posterior Stabilized Knee Replacement SystemConformis, Inc.2020—
+1K203447iTotal Identity Cruciate Retaining (CR) Total Knee Replacement, iTotal…Conformis, Inc.2020—
+1K210191Identity Imprint Knee Replacement SystemConformis, Inc.20211
+1K212411Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.2021—
+2K213389Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity…Conformis, Inc.2021—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198110
198410
198510
198720
198810
199010
199140
199250
199360
199490
1995130
199660
199780
199830
199920
200060
200160
200260
200350
200470
200550
200640
200740
200830
200910
201030
201130
201280
201310
201430
201530
201630
201810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202020
202150
202220
202350
202510
FIG. 1 — Lineage of K190562, 1981–2025Source: 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? (3)

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
*K180906Conformis iTotal Cruciate Retaining (CR) Knee Replacement System
Summary page 4
…/Metal/Polymer + Additive Legally Marketed Conformis iTotal® Cruciate Retaining Knee Replacement System Predicate Device (“iTotal CR KRS”), K180906, cleared May 16, 2018). (Primary Predicate): Legally Marketed Total Joint Orthopedics, Inc., Klassic® Knee System…
Conformis, Inc.20184
*K161668ConforMIS iTotal (R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS)
Summary page 5
…SUMMARY (page 2 of 5) Conformis iTotal Posterior Stabilized (PS) Knee Replacement System (iTotal PS KRS), K161668, cleared July 15, 2016 Device Description: The iTotal Identity® Cruciate Retaining Knee Replacement…
Conformis, Inc.20164
*K180159Klassic® Knee System
Summary page 4
…(“iTotal CR KRS”), K180906, cleared May 16, 2018). (Primary Predicate): Legally Marketed Total Joint Orthopedics, Inc., Klassic® Knee System (K180159, Predicate Device March 9, 2018), hereafter referred to as “TJO Klassic Knee.” Conformis iTotal Identity CR Kne…
Total Joint Orthopedics, Inc.2018—

Also cleared against K180906: 2 other devices →

What descends from it? (15)

See all 15

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

NumberDeviceApplicantDecidedDescendants
K201023iTotal® Identity Posterior Stabilized Knee Replacement SystemConformis, Inc.202014
K203447iTotal Identity Cruciate Retaining (CR) Total Knee Replacement, iTotal Identity…Conformis, Inc.202012
K210191Identity Imprint Knee Replacement SystemConformis, Inc.202110
K212411Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20219

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 38 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
  • 70 of the 151 ancestors have a recall of any class.
  • Of its descendants, K201023 (Conformis, Inc., 2020) has gone furthest, with 14 descendants of its own.
  • 2 other devices also cite its predicate K180906.

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. 2019, 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?

The iTotal Identity Cruciate Retaining (CR) Knee Replacement System (KRS) is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral or bicompartmental prosthesis. The Indications for Use include: » Painful joint disease due to osteoarthritis…

Read the full statement (146 words)

The iTotal Identity Cruciate Retaining (CR) Knee Replacement System (KRS) is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral or bicompartmental prosthesis.

The Indications for Use include:

» Painful joint disease due to osteoarthritis, traumatic arthritis, rheumatoid arthritis or osteonecrosis of the knee.

* Post traumatic loss of joint function.

* Moderate varus, valgus or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.

* Failed osteotomies, hemiarthroplasties, and unicondylar, patellofemoral or bicompartmental implants.

* Revision procedures provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.

This implant is intended for cemented use only.

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 K180906

2 other devices cite the same predicate.

  • K203421Triathlon AS-1Conformis, Inc. · 2021
  • K193105iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee Repair System, iTotal CR Knee…Conformis, Inc. · 2020

More from Conformis, Inc.

60 FDA decisions under this applicant name. See the company

  • K232426Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS)…Conformis, Inc. · 2023
  • K223316Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate Retaining Total Knee…Conformis, Inc. · 2023
  • K230846iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement SystemConformis, Inc. · 2023
  • K231233Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRSConformis, Inc. · 20231 recall
  • K231178ACTERA™ hip systemConformis, Inc. · 2023

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/K190562 · printed Nov 6, 2026

Cite this page

510(k) Report. “K190562: iTotal Identity Cruciate Retaining Knee Replacement System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190562

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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