510(k) · Cleared
ClearedIdentity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint Posterior Stabilized (PS) Knee Replacement System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Conformis, Inc. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Nov 10, 2021 as substantially equivalent to K212411 (Conformis, Inc., 2021) and 2 other predicates after a 26-day review. Its family tree reaches back 21 generations to 1981. 8 later devices descend from it.
- Decided
- Nov 10, 2021
- Review
- 26 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 21 generations to K810258 (1981). 281 ancestors in all. 8 later devices descend from it, 1 citing it directly.
- Root · 21 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 17 generations between
- 3 generations backK203447 iTotal Identity Cruciate Retaining (CR) Total Knee Replacement…Conformis, Inc. · 2020
- 2 generations backK210191 Identity Imprint Knee Replacement SystemConformis, Inc. · 2021 · Recalled
- 1 generation backK212411 Identity Imprint Knee Replacement System (including Identity Imprint…Conformis, Inc. · 2021
- This deviceK213389 Identity Imprint Cruciate Retaining (CR) Knee Replacement System and…Conformis, Inc. · 2021
- Descendant · cites it directly · 7 of its ownK221059 Identity Imprint Knee Replacement System (including Identity Imprint…Conformis, Inc. · 2022
- Descendant · 2 generations on · 6 of its ownK221404 Identity Imprint Knee Replacement System (including Identity Imprint…Conformis, Inc. · 2022
- Descendant · 3 generations on · 2 of its ownK223316 Identity Imprint Porous Total Knee Replacement System, Identity…Conformis, Inc. · 2023
- Descendant · 3 generations on · 2 of its ownK230846 iTotal Identity Knee Replacement System; Identity Imprint Knee…Conformis, Inc. · 2023
- Descendant · 3 generations on · 1 of its ownK230844 Identity Imprint Cruciate Retaining (CR) Knee Replacement System…Conformis, Inc. · 2023
Show all 21 generations
- Root · 21 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 20 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
- 19 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
- 18 generations backK050327 E-Poly (Vitamin E) Acetabular LinersBiomet, Inc. · 2005
- 17 generations backK070364 100KGY E-Poly Maxrom Acetabular LinersBiomet, Inc. · 2007
- 16 generations backK080528 E-Poly Tibial BearingsBiomet Orthopedics, Inc. · 2008
- 15 generations backK091956 Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model…Encore Medical L.P. · 2010 · Recalled
- 14 generations backK103223 Highly Cross-Linked Vitamin E Uhmwpe Tibial InsertsEncore Medical L.P. · 2010
- 13 generations backK122870 Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 2013
- 12 generations backK131019 Itotal Cruciate Retaining (C) Knee Replacement SystemConformis, Inc. · 2013
- 11 generations backK140423 Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 2014 · Recalled
- 10 generations backK142161 Itotal Cruciate Retaining (CR) Knee Replacement System, Itotal…Conformis, Inc. · 2014 · Recalled
- 9 generations backK152704 iTotal Posterior Stabilized Knee Replacement System, iTotal Cruciate…Conformis, Inc. · 2015
- 8 generations backK160025 iTotal Posterior Stabilized (PS) Knee Replacement System, iTotal…Conformis, Inc. · 2016 · Recalled
- 7 generations backK161366 ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System…Conformis, Inc. · 2016
- 6 generations backK180906 Conformis iTotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 2018 · Recalled
- 5 generations backK190562 iTotal Identity Cruciate Retaining Knee Replacement SystemConformis, Inc. · 2019
- 4 generations backK201023 iTotal® Identity Posterior Stabilized Knee Replacement SystemConformis, Inc. · 2020
- 3 generations backK203447 iTotal Identity Cruciate Retaining (CR) Total Knee Replacement…Conformis, Inc. · 2020
- 2 generations backK210191 Identity Imprint Knee Replacement SystemConformis, Inc. · 2021 · Recalled
- 1 generation backK212411 Identity Imprint Knee Replacement System (including Identity Imprint…Conformis, Inc. · 2021
- This deviceK213389 Identity Imprint Cruciate Retaining (CR) Knee Replacement System and…Conformis, Inc. · 2021
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K221059Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc. · 2022 · cites it directly7descendants
- K221404Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc. · 2022 · 2 generations on6descendants
- K223316Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate…Conformis, Inc. · 2023 · 3 generations on2descendants
- K230846iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement SystemConformis, Inc. · 2023 · 3 generations on2descendants
- K230844Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate…Conformis, Inc. · 2023 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −21 | K810258 | Proximal Fermoral Hip Replacement | Biomet, Inc. | 1981 | — |
| −20 | K974558 | Salvage/Onocology Hip and Total Femur System | Biomet, Inc. | 1998 | — |
| −19 | K032396 | Ringloc 36MM Line and Modular Femoral Heads | Biomet, Inc. | 2003 | 3 |
| −18 | K050327 | E-Poly (Vitamin E) Acetabular Liners | Biomet, Inc. | 2005 | — |
| −17 | K070364 | 100KGY E-Poly Maxrom Acetabular Liners | Biomet, Inc. | 2007 | — |
| −16 | K080528 | E-Poly Tibial Bearings | Biomet Orthopedics, Inc. | 2008 | — |
| −15 | K091956 | Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model 391/392-09_19-702_712 | Encore Medical L.P. | 2010 | 4 |
| −14 | K103223 | Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts | Encore Medical L.P. | 2010 | — |
| −13 | K122870 | Itotal Cruciate Retaining (CR) Knee Replacement System | Conformis, Inc. | 2013 | — |
| −12 | K131019 | Itotal Cruciate Retaining (C) Knee Replacement System | Conformis, Inc. | 2013 | — |
| −11 | K140423 | Itotal Cruciate Retaining (CR) Knee Replacement System | Conformis, Inc. | 2014 | 1 |
| −10 | K142161 | Itotal Cruciate Retaining (CR) Knee Replacement System, Itotal Posterior… | Conformis, Inc. | 2014 | 6 |
| −9 | K152704 | iTotal Posterior Stabilized Knee Replacement System, iTotal Cruciate Retaining… | Conformis, Inc. | 2015 | — |
| −8 | K160025 | iTotal Posterior Stabilized (PS) Knee Replacement System, iTotal Cruciate… | Conformis, Inc. | 2016 | 1 |
| −7 | K161366 | ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS) | Conformis, Inc. | 2016 | — |
| −6 | K180906 | Conformis iTotal Cruciate Retaining (CR) Knee Replacement System | Conformis, Inc. | 2018 | 4 |
| −5 | K190562 | iTotal Identity Cruciate Retaining Knee Replacement System | Conformis, Inc. | 2019 | — |
| −4 | K201023 | iTotal® Identity Posterior Stabilized Knee Replacement System | Conformis, Inc. | 2020 | — |
| −3 | K203447 | iTotal Identity Cruciate Retaining (CR) Total Knee Replacement, iTotal… | Conformis, Inc. | 2020 | — |
| −2 | K210191 | Identity Imprint Knee Replacement System | Conformis, Inc. | 2021 | 1 |
| −1 | K212411 | Identity Imprint Knee Replacement System (including Identity Imprint Posterior… | Conformis, Inc. | 2021 | — |
| 0 (this device) | K213389 | Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity… | Conformis, Inc. | 2021 | — |
| +1 | K221059 | Identity Imprint Knee Replacement System (including Identity Imprint Posterior… | Conformis, Inc. | 2022 | — |
| +2 | K221404 | Identity Imprint Knee Replacement System (including Identity Imprint Posterior… | Conformis, Inc. | 2022 | — |
| +3 | K223316 | Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous… | Conformis, Inc. | 2023 | — |
| +3 | K230846 | iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement… | Conformis, Inc. | 2023 | — |
| +3 | K230844 | Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with… | Conformis, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 3 | 0 |
| 1986 | 3 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 7 | 0 |
| 1992 | 7 | 0 |
| 1993 | 13 | 0 |
| 1994 | 24 | 0 |
| 1995 | 18 | 0 |
| 1996 | 21 | 0 |
| 1997 | 14 | 0 |
| 1998 | 7 | 0 |
| 1999 | 9 | 0 |
| 2000 | 14 | 0 |
| 2001 | 13 | 0 |
| 2002 | 10 | 0 |
| 2003 | 8 | 0 |
| 2004 | 12 | 0 |
| 2005 | 9 | 0 |
| 2006 | 7 | 0 |
| 2007 | 8 | 0 |
| 2008 | 5 | 0 |
| 2009 | 3 | 0 |
| 2010 | 6 | 0 |
| 2011 | 6 | 0 |
| 2012 | 11 | 0 |
| 2013 | 2 | 0 |
| 2014 | 4 | 0 |
| 2015 | 3 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 2 | 0 |
| 2023 | 5 | 0 |
| 2025 | 1 | 0 |
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 K221479 Persona Personalized Knee Systemscore 22.4 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K212411 | Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Summary page 5…ry Predicate): Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS (K212411/K210191) (Secondary Predicates): Conformis iTotal Hip Replacement System (K192198) Device Description: Special 510(k… | 2021 |
| * | K210191 | Identity Imprint Knee Replacement SystemSummary page 5…cate): Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS (K212411/K210191) (Secondary Predicates): Conformis iTotal Hip Replacement System (K192198) Device Description: Special 510(k) – Conf… | 2021 |
| * | K192198 | Conformis Hip SystemSummary page 5…terior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS (K212411/K210191) (Secondary Predicates): Conformis iTotal Hip Replacement System (K192198) Device Description: Special 510(k) – Conformis Identity Imprint Knee Replacement System… | 2019 |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K221059 | Identity Imprint Knee Replacement System (including Identity Imprint Posterior… | 2022 | 7 |
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 40 years and passes through 4 companies; a new generation was cleared every 11 months on median.
- 100 of the 281 ancestors have a recall of any class.
- Of its descendants, K221059 (Conformis, Inc., 2022) has gone furthest, with 7 descendants of its own.
How does its category compare?
All JWH devicesJWH 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
2026 to Oct 25, outlined.
Median 510(k) review, days · JWH
55in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JWH
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JWH
9,306in 2025
MAUDE reports naming product code JWH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 18 | 74 | 14 | 1,305 |
| 2008 | 17 | 81 | 10 | 1,483 |
| 2009 | 11 | 168 | 109 | 1,870 |
| 2010 | 19 | 85 | 32 | 3,286 |
| 2011 | 25 | 87 | 27 | 5,133 |
| 2012 | 33 | 85 | 85 | 5,203 |
| 2013 | 31 | 128 | 31 | 6,135 |
| 2014 | 33 | 98 | 13 | 6,722 |
| 2015 | 27 | 87 | 11 | 6,881 |
| 2016 | 18 | 88 | 17 | 7,586 |
| 2017 | 25 | 118 | 61 | 12,263 |
| 2018 | 25 | 90 | 14 | 14,071 |
| 2019 | 28 | 133 | 5 | 14,987 |
| 2020 | 22 | 59 | 2 | 12,592 |
| 2021 | 24 | 61 | 8 | 9,408 |
| 2022 | 17 | 56 | 12 | 8,364 |
| 2023 | 20 | 57 | 67 | 8,947 |
| 2024 | 19 | 89 | 7 | 10,828 |
| 2025 | 20 | 55 | 2 | 9,306 |
| 2026 | 12 | 63 | 4 | — |
What is it indicated for?
Identity Imprint CR KRS The Identity Imprint CR 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 the 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…
Read the full statement (281 words)
Identity Imprint CR KRS
The Identity Imprint CR 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 the 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 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.
Identity Imprint PS KRS
The Identity Imprint PS 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 the 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 or flexion deformity
» Failed osteotomies, hemiarthroplasties, and unicondylar, patellofemoral or bicompartental implants
* Revision procedures provided that the 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.
https://510kreport.com/device/K213389 · printed Nov 4, 2026
Cite this page
510(k) Report. “K213389: Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint Posterior Stabilized (PS) Knee Replacement System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K213389
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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