510(k) · Cleared
ClearedIdentity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Inserts
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Conformis, Inc. · MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Cleared on Sep 8, 2023 as substantially equivalent to K223316 (Conformis, Inc., 2023) and 2 other predicates after a 28-day review. Its family tree reaches back 25 generations to 1981.
- Decided
- Sep 8, 2023
- Review
- 28 days
- Class
- Class II
- Product code
- MBH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 25 generations to K810258 (1981). 321 ancestors in all. No later device cites it as a predicate yet.
- Root · 25 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 21 generations between
- 3 generations backK221059 Identity Imprint Knee Replacement System (including Identity Imprint…Conformis, Inc. · 2022
- 2 generations backK221404 Identity Imprint Knee Replacement System (including Identity Imprint…Conformis, Inc. · 2022
- 1 generation backK230844 Identity Imprint Cruciate Retaining (CR) Knee Replacement System…Conformis, Inc. · 2023
- This deviceK232426 Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement…Conformis, Inc. · 2023
Show all 25 generations
- Root · 25 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 24 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
- 23 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
- 22 generations backK050327 E-Poly (Vitamin E) Acetabular LinersBiomet, Inc. · 2005
- 21 generations backK070364 100KGY E-Poly Maxrom Acetabular LinersBiomet, Inc. · 2007
- 20 generations backK080528 E-Poly Tibial BearingsBiomet Orthopedics, Inc. · 2008
- 19 generations backK091956 Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model…Encore Medical L.P. · 2010 · Recalled
- 18 generations backK103223 Highly Cross-Linked Vitamin E Uhmwpe Tibial InsertsEncore Medical L.P. · 2010
- 17 generations backK122870 Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 2013
- 16 generations backK131019 Itotal Cruciate Retaining (C) Knee Replacement SystemConformis, Inc. · 2013
- 15 generations backK140423 Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 2014 · Recalled
- 14 generations backK142161 Itotal Cruciate Retaining (CR) Knee Replacement System, Itotal…Conformis, Inc. · 2014 · Recalled
- 13 generations backK152704 iTotal Posterior Stabilized Knee Replacement System, iTotal Cruciate…Conformis, Inc. · 2015
- 12 generations backK160025 iTotal Posterior Stabilized (PS) Knee Replacement System, iTotal…Conformis, Inc. · 2016 · Recalled
- 11 generations backK161366 ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System…Conformis, Inc. · 2016
- 10 generations backK180906 Conformis iTotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 2018 · Recalled
- 9 generations backK190562 iTotal Identity Cruciate Retaining Knee Replacement SystemConformis, Inc. · 2019
- 8 generations backK201023 iTotal® Identity Posterior Stabilized Knee Replacement SystemConformis, Inc. · 2020
- 7 generations backK203447 iTotal Identity Cruciate Retaining (CR) Total Knee Replacement…Conformis, Inc. · 2020
- 6 generations backK210191 Identity Imprint Knee Replacement SystemConformis, Inc. · 2021 · Recalled
- 5 generations backK212411 Identity Imprint Knee Replacement System (including Identity Imprint…Conformis, Inc. · 2021
- 4 generations backK213389 Identity Imprint Cruciate Retaining (CR) Knee Replacement System and…Conformis, Inc. · 2021
- 3 generations backK221059 Identity Imprint Knee Replacement System (including Identity Imprint…Conformis, Inc. · 2022
- 2 generations backK221404 Identity Imprint Knee Replacement System (including Identity Imprint…Conformis, Inc. · 2022
- 1 generation backK230844 Identity Imprint Cruciate Retaining (CR) Knee Replacement System…Conformis, Inc. · 2023
- This deviceK232426 Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement…Conformis, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −25 | K810258 | Proximal Fermoral Hip Replacement | Biomet, Inc. | 1981 | — |
| −24 | K974558 | Salvage/Onocology Hip and Total Femur System | Biomet, Inc. | 1998 | — |
| −23 | K032396 | Ringloc 36MM Line and Modular Femoral Heads | Biomet, Inc. | 2003 | 3 |
| −22 | K050327 | E-Poly (Vitamin E) Acetabular Liners | Biomet, Inc. | 2005 | — |
| −21 | K070364 | 100KGY E-Poly Maxrom Acetabular Liners | Biomet, Inc. | 2007 | — |
| −20 | K080528 | E-Poly Tibial Bearings | Biomet Orthopedics, Inc. | 2008 | — |
| −19 | K091956 | Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model 391/392-09_19-702_712 | Encore Medical L.P. | 2010 | 4 |
| −18 | K103223 | Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts | Encore Medical L.P. | 2010 | — |
| −17 | K122870 | Itotal Cruciate Retaining (CR) Knee Replacement System | Conformis, Inc. | 2013 | — |
| −16 | K131019 | Itotal Cruciate Retaining (C) Knee Replacement System | Conformis, Inc. | 2013 | — |
| −15 | K140423 | Itotal Cruciate Retaining (CR) Knee Replacement System | Conformis, Inc. | 2014 | 1 |
| −14 | K142161 | Itotal Cruciate Retaining (CR) Knee Replacement System, Itotal Posterior… | Conformis, Inc. | 2014 | 6 |
| −13 | K152704 | iTotal Posterior Stabilized Knee Replacement System, iTotal Cruciate Retaining… | Conformis, Inc. | 2015 | — |
| −12 | K160025 | iTotal Posterior Stabilized (PS) Knee Replacement System, iTotal Cruciate… | Conformis, Inc. | 2016 | 1 |
| −11 | K161366 | ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS) | Conformis, Inc. | 2016 | — |
| −10 | K180906 | Conformis iTotal Cruciate Retaining (CR) Knee Replacement System | Conformis, Inc. | 2018 | 4 |
| −9 | K190562 | iTotal Identity Cruciate Retaining Knee Replacement System | Conformis, Inc. | 2019 | — |
| −8 | K201023 | iTotal® Identity Posterior Stabilized Knee Replacement System | Conformis, Inc. | 2020 | — |
| −7 | K203447 | iTotal Identity Cruciate Retaining (CR) Total Knee Replacement, iTotal… | Conformis, Inc. | 2020 | — |
| −6 | K210191 | Identity Imprint Knee Replacement System | Conformis, Inc. | 2021 | 1 |
| −5 | K212411 | Identity Imprint Knee Replacement System (including Identity Imprint Posterior… | Conformis, Inc. | 2021 | — |
| −4 | K213389 | Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity… | Conformis, Inc. | 2021 | — |
| −3 | 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 | — |
| −1 | K230844 | Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with… | Conformis, Inc. | 2023 | — |
| 0 (this device) | K232426 | Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS)… | 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 | 8 | 0 |
| 1992 | 7 | 0 |
| 1993 | 13 | 0 |
| 1994 | 26 | 0 |
| 1995 | 19 | 0 |
| 1996 | 22 | 0 |
| 1997 | 14 | 0 |
| 1998 | 8 | 0 |
| 1999 | 10 | 0 |
| 2000 | 16 | 0 |
| 2001 | 15 | 0 |
| 2002 | 12 | 0 |
| 2003 | 10 | 0 |
| 2004 | 12 | 0 |
| 2005 | 12 | 0 |
| 2006 | 8 | 0 |
| 2007 | 11 | 0 |
| 2008 | 6 | 0 |
| 2009 | 5 | 0 |
| 2010 | 9 | 0 |
| 2011 | 7 | 0 |
| 2012 | 13 | 0 |
| 2013 | 2 | 0 |
| 2014 | 5 | 0 |
| 2015 | 3 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2023 | 2 | 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 MBH? 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 MBH device
- #1 K241597 Freedom® Total Knee System - Porous Tibial…score 19.9 · 8 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 |
|---|---|---|---|
| * | K223316 | Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate…Summary page 5…ment System, Identity Primary Predicate Device: Imprint Porous Cruciate Retaining Total Knee Replacement System Primary Predicate 510(k): K223316 Primary Predicate Regulation 21 CFR 888.3565, 21 CFR 888.3560 Number(s) Primary Predicate Classification … | 2023 |
| * | K230844 | Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate…Summary page 5…Identity™ Imprint™ Cruciate Retaining (CR) Knee Replacement System with CS insert Second Predicate 510(k): K230844 Reference Predicate Regulation 21 CFR 888.3560 Number(s) Reference Predicate Classification JWH: Knee join… | 2023 |
| * | K230846 | iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement SystemSummary page 5…ystem (KRS) Identity Imprint Posterior Stabilizing (PS) Knee Replacement System (KRS) Third Predicate 510(k): K230846 Third Predicate Regulation Number(s) 21 CFR 888.3560 Third Predicate Classification … | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
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 42 years and passes through 4 companies; a new generation was cleared every 9 months on median.
- 113 of the 321 ancestors have a recall of any class.
- 1 other device also cites its predicate K223316.
How does its category compare?
All MBH devicesMBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · MBH
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MBH
98in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MBH
1in 2024
Class I (5 since 2007) Class II/III not classified
Adverse event reports per year · MBH
1,561in 2025
MAUDE reports naming product code MBH, 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 | 10 | 59 | 0 | 27 |
| 2008 | 3 | 70 | 0 | 21 |
| 2009 | 3 | 209 | 2 | 89 |
| 2010 | 4 | 84 | 0 | 121 |
| 2011 | 5 | 84 | 15 | 247 |
| 2012 | 5 | 90 | 1 (1) | 370 |
| 2013 | 6 | 138 | 4 (4) | 308 |
| 2014 | 9 | 114 | 0 | 385 |
| 2015 | 8 | 100 | 0 | 955 |
| 2016 | 4 | 74 | 1 | 1,034 |
| 2017 | 4 | 115 | 9 | 1,007 |
| 2018 | 6 | 89 | 1 | 1,191 |
| 2019 | 1 | — | 1 | 1,394 |
| 2020 | 7 | 112 | 2 | 1,089 |
| 2021 | 6 | 48 | 0 | 1,539 |
| 2022 | 7 | 57 | 0 | 1,261 |
| 2023 | 6 | 94 | 2 | 1,263 |
| 2024 | 10 | 84 | 1 | 1,497 |
| 2025 | 8 | 98 | 0 | 1,561 |
| 2026 | 7 | 153 | 4 | — |
What is it indicated for?
The Identity TM Imprint TM Porous Cruciate Retaining (CR) Total Knee Replacement System with Cruciate Sacrificing (CS) Insert 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…
Read the full statement (197 words)
The Identity TM Imprint TM Porous Cruciate Retaining (CR) Total Knee Replacement System with Cruciate Sacrificing (CS) Insert 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
The Ildentity M Imprint TM Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Insert is intended for uncemented use, but porous implants may be used with cement if desired by the surgeon.
The CS (cruciate sacrificing) insert option should be utilized when additional anterior-posterior constraint is desired.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232426 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232426: Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Inserts.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232426
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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