510(k) Report

510(k) · Cleared

Recalled · Class II · 2014

Itotal Cruciate Retaining (CR) Knee Replacement System

K140423510(k) TraditionalCleared May 27, 201498-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 27, 2014 as substantially equivalent to K131467 (Conformis, Inc., 2013) and 4 other predicates after a 98-day review. Its family tree reaches back 10 generations to 1981. 25 later devices descend from it. It has been recalled once.

Decided
May 27, 2014
Review
98 days
Class
Class II
Product code
JWH
Recalls
1
Predicates
5

Its longest line of descent runs back 10 generations to K810258 (1981). 79 ancestors in all. 25 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2013: 1 other ancestor2012: 6 other ancestors2011: 2 other ancestors2010: 2 other ancestors2006: 1 other ancestor2005: 3 other ancestors2004: 4 other ancestors2003: 3 other ancestors2002: 4 other ancestors2000: 2 other ancestors1999: 2 other ancestors1998: 2 other ancestors1996: 3 other ancestors1995: 8 other ancestors1994: 8 other ancestors1991: 1 other ancestor2001: 3 other ancestors1997: 3 other ancestors1993: 4 other ancestors1992: 4 other ancestors1988: 1 other ancestor1984: 1 other ancestor1981: 1 other ancestor2014: 1 descendant cleared2015: 1 descendant cleared2016: 5 descendants cleared2018: 1 descendant cleared2020: 3 descendants cleared2019: 1 descendant cleared2021: 5 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) 19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors2 generations back: 5 other ancestors3 generations back: 4 other ancestors4 generations back: 15 other ancestors5 generations back: 20 other ancestors6 generations back: 12 other ancestors7 generations back: 7 other ancestors8 generations back: 2 other ancestors 1 generation forward: 1 descendant2 generations forward: 4 descendants3 generations forward: 2 descendants4 generations forward: 4 descendants5 generations forward: 4 descendants6 generations forward: 2 descendants7 generations forward: 3 descendants8 generations forward: 3 descendants9 generations forward: 2 descendants K131019 · 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. · 1981−10−50+5
  1. Root · 10 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
  2. 6 generations between
  3. 3 generations backK103223 Highly Cross-Linked Vitamin E Uhmwpe Tibial InsertsEncore Medical L.P. · 2010
  4. 2 generations backK122870 Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 2013
  5. 1 generation backK131019 Itotal Cruciate Retaining (C) Knee Replacement SystemConformis, Inc. · 2013
  6. This deviceK140423 Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 2014
  7. Descendant · cites it directly · 24 of its ownK142161 Itotal Cruciate Retaining (CR) Knee Replacement System, Itotal…Conformis, Inc. · 2014 · Recalled
  8. Descendant · 2 generations on · 23 of its ownK152704 iTotal Posterior Stabilized Knee Replacement System, iTotal Cruciate…Conformis, Inc. · 2015
  9. Descendant · 2 generations on · 20 of its ownK160025 iTotal Posterior Stabilized (PS) Knee Replacement System, iTotal…Conformis, Inc. · 2016 · Recalled
  10. Descendant · 3 generations on · 18 of its ownK161366 ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System…Conformis, Inc. · 2016
  11. Descendant · 2 generations on · 18 of its ownK153217 ConforMIS iTotal Posterior Stabilized Knee Replacement SystemConformis, Inc. · 2016
Show all 10 generations
  1. Root · 10 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
  2. 9 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
  3. 8 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
  4. 7 generations backK050327 E-Poly (Vitamin E) Acetabular LinersBiomet, Inc. · 2005
  5. 6 generations backK070364 100KGY E-Poly Maxrom Acetabular LinersBiomet, Inc. · 2007
  6. 5 generations backK080528 E-Poly Tibial BearingsBiomet Orthopedics, Inc. · 2008
  7. 4 generations backK091956 Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model…Encore Medical L.P. · 2010 · Recalled
  8. 3 generations backK103223 Highly Cross-Linked Vitamin E Uhmwpe Tibial InsertsEncore Medical L.P. · 2010
  9. 2 generations backK122870 Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 2013
  10. 1 generation backK131019 Itotal Cruciate Retaining (C) Knee Replacement SystemConformis, Inc. · 2013
  11. This deviceK140423 Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 2014

Showing 5 of 25 descendants. See all descendants

Descendants cleared per year

2014: 12015: 12016: 52018: 12019: 12020: 32021: 52022: 22023: 52025: 1
2014high 5 (2016) · low 0 (2017)2026

Most influential descendants

Showing 5 of 25 · See all
  • K142161Itotal Cruciate Retaining (CR) Knee Replacement System, Itotal Posterior Stabilized (PS)…Conformis, Inc. · 2014 · cites it directly24descendants
  • K152704iTotal Posterior Stabilized Knee Replacement System, iTotal Cruciate Retaining Knee…Conformis, Inc. · 2015 · 2 generations on23descendants
  • K160025iTotal Posterior Stabilized (PS) Knee Replacement System, iTotal Cruciate Retaining (CR)…Conformis, Inc. · 2016 · 2 generations on20descendants
  • K161366ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS)Conformis, Inc. · 2016 · 3 generations on18descendants
  • K153217ConforMIS iTotal Posterior Stabilized Knee Replacement SystemConformis, Inc. · 2016 · 2 generations on18descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−10K810258Proximal Fermoral Hip ReplacementBiomet, Inc.1981—
−9K974558Salvage/Onocology Hip and Total Femur SystemBiomet, Inc.1998—
−8K032396Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc.20033
−7K050327E-Poly (Vitamin E) Acetabular LinersBiomet, Inc.2005—
−6K070364100KGY E-Poly Maxrom Acetabular LinersBiomet, Inc.2007—
−5K080528E-Poly Tibial BearingsBiomet Orthopedics, Inc.2008—
−4K091956Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model 391/392-09_19-702_712Encore Medical L.P.20104
−3K103223Highly Cross-Linked Vitamin E Uhmwpe Tibial InsertsEncore Medical L.P.2010—
−2K122870Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.2013—
−1K131019Itotal Cruciate Retaining (C) Knee Replacement SystemConformis, Inc.2013—
0 (this device)K140423Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.2014—
+1K142161Itotal Cruciate Retaining (CR) Knee Replacement System, Itotal Posterior…Conformis, Inc.20146
+2K152704iTotal Posterior Stabilized Knee Replacement System, iTotal Cruciate Retaining…Conformis, Inc.2015—
+2K160025iTotal Posterior Stabilized (PS) Knee Replacement System, iTotal Cruciate…Conformis, Inc.20161
+3K161366ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS)Conformis, Inc.2016—
+2K153217ConforMIS iTotal Posterior Stabilized Knee Replacement SystemConformis, Inc.2016—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198110
198410
198810
199110
199240
199340
199480
199580
199630
199730
199820
199920
200020
200130
200240
200330
200440
200530
200610
201020
201120
201260
201310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
201510
201650
201810
201910
202030
202150
202220
202350
202510
FIG. 1 — Lineage of K140423, 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? (5)

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
*K131467Itotal Cruciate Retaining (CR) Knee Replacement System
Summary page 4
…ciate Retaining Knee Replacement System Replacement System (K131467, K131019, K122991, K122033 & (ibis submission) K120068)…
Conformis, Inc.2013—
*K131019Itotal Cruciate Retaining (C) Knee Replacement System
Summary page 2
…: JWH, OOG, OlY Regulation Number: 21 CIFR 888.3560 510(k) Number: K(131467. K131019, K122991. K122033, and K(12008…
Conformis, Inc.2013—
*K122991Itotal Cruciate Retaining (CR) Knee Replacement System
Summary page 2
…WH, OOG, OlY Regulation Number: 21 CIFR 888.3560 510(k) Number: K(131467. K131019, K122991. K122033, and K(12008…
Conformis, Inc.2012—
*K122033Itotal Cruciate Retaining (CR) Knee Replacement System
Summary page 2
…OlY Regulation Number: 21 CIFR 888.3560 510(k) Number: K(131467. K131019, K122991. K122033, and K(12008…
Conformis, Inc.2012—
*K120068Conformis Itotal CR Knee Replacement System (KRS)
Summary page 4
…stem (K131467, K131019, K122991, K122033 & (ibis submission) K120068) - Indication for Use The iTotal CR Knee Replacement System The iTotal CR Knee Replacement System…
Conformis, Inc.2012—

Also cleared against K131467: 3 other devices →

What descends from it? (25)

See all 25

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

NumberDeviceApplicantDecidedDescendants
K142161Itotal Cruciate Retaining (CR) Knee Replacement System, Itotal Posterior Stabilized (PS)…Conformis, Inc.201424

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

Recalls of this device

DateClassRecallRoot causeReason
Nov 19, 2014Class IIZ-0581-2015Labeling mix-upsIncorrect serial number of tibial inserts packaged in tray may result in inserts not fitting

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 33 years and passes through 4 companies; a new generation was cleared every 2.1 years on median.
  • 32 of the 79 ancestors have a recall of any class.
  • Of its descendants, K142161 (Conformis, Inc., 2014) has gone furthest, with 24 descendants of its own.
  • 3 other devices also cite its predicate K131467.

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. 2014, 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 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…

Read the full statement (143 words)

The iTotal 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 as stated in the FDA summary.

Also cleared against K131467

3 other devices cite the same predicate.

  • K140833Itotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc. · 2014
  • K133560Itotal Cruciate Retaining Knee Replacment SystemConformis, Inc. · 2014
  • K133256Itotal Cruciate Retaining, Iuni Unicondylar Knee Replacement Systems, Iduo Bicompartmental Knee Repair SystemConformis, Inc. · 20146 recalls

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/K140423 · printed Nov 6, 2026

Cite this page

510(k) Report. “K140423: Itotal Cruciate Retaining (CR) 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/K140423

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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