510(k) Report

510(k) · Cleared

Recalled · Class II · 2024

Identity Imprint Knee Replacement System

K210191510(k) TraditionalCleared May 6, 2021101-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

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

Cleared on May 6, 2021 as substantially equivalent to K190562 (Conformis, Inc., 2019) and 2 other predicates after a 101-day review. Its family tree reaches back 19 generations to 1981. 10 later devices descend from it. It has been recalled once.

Decided
May 6, 2021
Review
101 days
Class
Class II
Product code
JWH
Recalls
1
Predicates
3

Its longest line of descent runs back 19 generations to K810258 (1981). 178 ancestors in all. 10 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2020: 1 other ancestor2018: 1 other ancestor2016: 3 other ancestors2006: 6 other ancestors1996: 9 other ancestors2015: 3 other ancestors2014: 4 other ancestors2013: 2 other ancestors2012: 9 other ancestors2009: 3 other ancestors2004: 8 other ancestors2011: 4 other ancestors2007: 7 other ancestors2001: 8 other ancestors2000: 6 other ancestors1995: 13 other ancestors1993: 6 other ancestors1991: 5 other ancestors1987: 2 other ancestors2010: 4 other ancestors2005: 6 other ancestors2003: 5 other ancestors2002: 8 other ancestors1998: 3 other ancestors1997: 9 other ancestors1994: 9 other ancestors1990: 1 other ancestor1985: 1 other ancestor1992: 5 other ancestors1988: 1 other ancestor2008: 3 other ancestors1999: 2 other ancestors1984: 1 other ancestor1981: 1 other ancestor2021: 2 descendants cleared2022: 2 descendants cleared2023: 5 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 · recalledK190562 · iTotal Identity Cruciate Retaining Knee Replacement System · Conformis, Inc. · 2019K201023 · iTotal® Identity Posterior Stabilized Knee Replacement System · Conformis, Inc. · 2020K203447 · iTotal Identity Cruciate Retaining (CR) Total Knee Replacement, iTotal Identity Posterior Stabilizing (PS) Total Knee Replacement · Conformis, Inc. · 202019801990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 5 other ancestors3 generations back: 11 other ancestors4 generations back: 17 other ancestors5 generations back: 42 other ancestors6 generations back: 28 other ancestors7 generations back: 34 other ancestors8 generations back: 12 other ancestors9 generations back: 9 other ancestors10 generations back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 1 descendant3 generations forward: 1 descendant4 generations forward: 4 descendants5 generations forward: 2 descendants K203447 · iTotal Identity Cruciate Retaining (CR) Total Knee Replacement, iTotal Identity Posterior Stabilizing (PS) Total Knee Replacement · Conformis, Inc. · 2020K201023 · iTotal® Identity Posterior Stabilized Knee Replacement System · Conformis, Inc. · 2020K190562 · iTotal Identity Cruciate Retaining Knee Replacement System · Conformis, Inc. · 2019K180906 · 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 · 19 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
  2. 15 generations between
  3. 3 generations backK190562 iTotal Identity Cruciate Retaining Knee Replacement SystemConformis, Inc. · 2019
  4. 2 generations backK201023 iTotal® Identity Posterior Stabilized Knee Replacement SystemConformis, Inc. · 2020
  5. 1 generation backK203447 iTotal Identity Cruciate Retaining (CR) Total Knee Replacement…Conformis, Inc. · 2020
  6. This deviceK210191 Identity Imprint Knee Replacement SystemConformis, Inc. · 2021
  7. Descendant · cites it directly · 9 of its ownK212411 Identity Imprint Knee Replacement System (including Identity Imprint…Conformis, Inc. · 2021
  8. Descendant · cites it directly · 8 of its ownK213389 Identity Imprint Cruciate Retaining (CR) Knee Replacement System and…Conformis, Inc. · 2021
  9. Descendant · 2 generations on · 7 of its ownK221059 Identity Imprint Knee Replacement System (including Identity Imprint…Conformis, Inc. · 2022
  10. Descendant · 3 generations on · 6 of its ownK221404 Identity Imprint Knee Replacement System (including Identity Imprint…Conformis, Inc. · 2022
  11. Descendant · 4 generations on · 2 of its ownK223316 Identity Imprint Porous Total Knee Replacement System, Identity…Conformis, Inc. · 2023
Show all 19 generations
  1. Root · 19 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
  2. 18 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
  3. 17 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
  4. 16 generations backK050327 E-Poly (Vitamin E) Acetabular LinersBiomet, Inc. · 2005
  5. 15 generations backK070364 100KGY E-Poly Maxrom Acetabular LinersBiomet, Inc. · 2007
  6. 14 generations backK080528 E-Poly Tibial BearingsBiomet Orthopedics, Inc. · 2008
  7. 13 generations backK091956 Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model…Encore Medical L.P. · 2010 · Recalled
  8. 12 generations backK103223 Highly Cross-Linked Vitamin E Uhmwpe Tibial InsertsEncore Medical L.P. · 2010
  9. 11 generations backK122870 Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 2013
  10. 10 generations backK131019 Itotal Cruciate Retaining (C) Knee Replacement SystemConformis, Inc. · 2013
  11. 9 generations backK140423 Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 2014 · Recalled
  12. 8 generations backK142161 Itotal Cruciate Retaining (CR) Knee Replacement System, Itotal…Conformis, Inc. · 2014 · Recalled
  13. 7 generations backK152704 iTotal Posterior Stabilized Knee Replacement System, iTotal Cruciate…Conformis, Inc. · 2015
  14. 6 generations backK160025 iTotal Posterior Stabilized (PS) Knee Replacement System, iTotal…Conformis, Inc. · 2016 · Recalled
  15. 5 generations backK161366 ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System…Conformis, Inc. · 2016
  16. 4 generations backK180906 Conformis iTotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 2018 · Recalled
  17. 3 generations backK190562 iTotal Identity Cruciate Retaining Knee Replacement SystemConformis, Inc. · 2019
  18. 2 generations backK201023 iTotal® Identity Posterior Stabilized Knee Replacement SystemConformis, Inc. · 2020
  19. 1 generation backK203447 iTotal Identity Cruciate Retaining (CR) Total Knee Replacement…Conformis, Inc. · 2020
  20. This deviceK210191 Identity Imprint Knee Replacement SystemConformis, Inc. · 2021

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2021: 22022: 22023: 52025: 1
2021high 5 (2023) · low 0 (2024)2026

Most influential descendants

Showing 5 of 10 · See all
  • 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 · cites it directly8descendants
  • K221059Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc. · 2022 · 2 generations on7descendants
  • K221404Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc. · 2022 · 3 generations on6descendants
  • K223316Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate…Conformis, Inc. · 2023 · 4 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−19K810258Proximal Fermoral Hip ReplacementBiomet, Inc.1981—
−18K974558Salvage/Onocology Hip and Total Femur SystemBiomet, Inc.1998—
−17K032396Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc.20033
−16K050327E-Poly (Vitamin E) Acetabular LinersBiomet, Inc.2005—
−15K070364100KGY E-Poly Maxrom Acetabular LinersBiomet, Inc.2007—
−14K080528E-Poly Tibial BearingsBiomet Orthopedics, Inc.2008—
−13K091956Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model 391/392-09_19-702_712Encore Medical L.P.20104
−12K103223Highly Cross-Linked Vitamin E Uhmwpe Tibial InsertsEncore Medical L.P.2010—
−11K122870Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.2013—
−10K131019Itotal Cruciate Retaining (C) Knee Replacement SystemConformis, Inc.2013—
−9K140423Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.20141
−8K142161Itotal Cruciate Retaining (CR) Knee Replacement System, Itotal Posterior…Conformis, Inc.20146
−7K152704iTotal Posterior Stabilized Knee Replacement System, iTotal Cruciate Retaining…Conformis, Inc.2015—
−6K160025iTotal Posterior Stabilized (PS) Knee Replacement System, iTotal Cruciate…Conformis, Inc.20161
−5K161366ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS)Conformis, Inc.2016—
−4K180906Conformis iTotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.20184
−3K190562iTotal Identity Cruciate Retaining Knee Replacement SystemConformis, Inc.2019—
−2K201023iTotal® Identity Posterior Stabilized Knee Replacement SystemConformis, Inc.2020—
−1K203447iTotal Identity Cruciate Retaining (CR) Total Knee Replacement, iTotal…Conformis, Inc.2020—
0 (this device)K210191Identity Imprint Knee Replacement SystemConformis, Inc.2021—
+1K212411Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.2021—
+1K213389Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity…Conformis, Inc.2021—
+2K221059Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.2022—
+3K221404Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.2022—
+4K223316Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous…Conformis, Inc.2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198110
198410
198510
198720
198810
199010
199150
199250
199360
199490
1995130
199690
199790
199830
199920
200060
200180
200280
200350
200480
200560
200660
200770
200830
200930
201040
201140
201290
201320
201440
201530
201630
201810
202010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202120
202220
202350
202510
FIG. 1 — Lineage of K210191, 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
*K190562iTotal Identity Cruciate Retaining Knee Replacement System
Summary page 4
…plasty Implantation System; JWH, OIY, OOG Legally Marketed Predicate Device (Primary Predicate): iTotal Identity Cruciate Retaining (CR) Knee Replacement System (K190562) (Secondary Predicates): iTotal Identity Posterior Stabilized (PS) Knee Replacement System (K201023) iTotal CR & PS…
Conformis, Inc.2019—
*K201023iTotal® Identity Posterior Stabilized Knee Replacement System
Summary page 4
…al Identity Cruciate Retaining (CR) Knee Replacement System (K190562) (Secondary Predicates): iTotal Identity Posterior Stabilized (PS) Knee Replacement System (K201023) iTotal CR & PS KRS – addition of iPoly XE NMA GUR 1020E (K203447) Device Description: The subject device, Identity Imprin…
Conformis, Inc.2020—
*K203447iTotal Identity Cruciate Retaining (CR) Total Knee Replacement, iTotal Identity…
Summary page 4
…(Secondary Predicates): iTotal Identity Posterior Stabilized (PS) Knee Replacement System (K201023) iTotal CR & PS KRS – addition of iPoly XE NMA GUR 1020E (K203447) Device Description: The subject device, Identity Imprint Knee Replacement System, is a new device offering of a Traditional…
Conformis, Inc.2020—

Also cleared against K190562: 3 other devices →

What descends from it? (10)

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

NumberDeviceApplicantDecidedDescendants
K212411Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20219
K213389Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint…Conformis, Inc.20218

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

Recalls of this device

DateClassRecallRoot causeReason
Mar 11, 2024Class IIZ-1591-2024Process designSize 5 Tibial Tray from Lot 508287 was packaged in a Size 4 box from Lot 540287. It was confirmed that Lot 540287 and Lot 508287 were swapped between the pouching and final pack.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 40 years and passes through 4 companies; a new generation was cleared every 1.0 years on median.
  • 83 of the 178 ancestors have a recall of any class.
  • Of its descendants, K212411 (Conformis, Inc., 2021) has gone furthest, with 9 descendants of its own.
  • 3 other devices also cite its predicate K190562.

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. 2021, 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 Identity Imprint Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by use of a prosthetic device that treats only one or two of the three knee compartments, such as unicondylar, patellofemoral or bicompartmental prosthesis. The Indications for Use include: • Painful joint disease due to osteoarthritis, traumatic arthritis, rheumatoid…

Read the full statement (128 words)

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

The Indications for Use include:

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

• Post traumatic loss of joint function.

• Moderate varus, valgus of flexion deformity.

• 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 as stated in the FDA summary.

Also cleared against K190562

3 other devices cite the same predicate.

  • K212411Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and…Conformis, Inc. · 2021
  • K203447iTotal Identity Cruciate Retaining (CR) Total Knee Replacement, iTotal Identity Posterior Stabilizing (PS)…Conformis, Inc. · 2020
  • K201023iTotal® Identity Posterior Stabilized Knee Replacement SystemConformis, 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/K210191 · printed Nov 6, 2026

Cite this page

510(k) Report. “K210191: Identity Imprint 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/K210191

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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