510(k) · Cleared
ClearediUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee Repair System, iTotal CR Knee Replacement System, iTotal 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 Mar 13, 2020 as substantially equivalent to K180906 (Conformis, Inc., 2018) and 4 other predicates after a 126-day review. Its family tree reaches back 16 generations to 1981. 15 later devices descend from it.
- Decided
- Mar 13, 2020
- Review
- 126 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 16 generations to K810258 (1981). 136 ancestors in all. 15 later devices descend from it, 1 citing it directly.
- Root · 16 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 12 generations between
- 3 generations backK160025 iTotal Posterior Stabilized (PS) Knee Replacement System, iTotal…Conformis, Inc. · 2016 · Recalled
- 2 generations backK161366 ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System…Conformis, Inc. · 2016
- 1 generation backK180906 Conformis iTotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 2018 · Recalled
- This deviceK193105 iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee…Conformis, Inc. · 2020
- Descendant · cites it directly · 14 of its ownK201023 iTotal® Identity Posterior Stabilized Knee Replacement SystemConformis, Inc. · 2020
- Descendant · 2 generations on · 12 of its ownK203447 iTotal Identity Cruciate Retaining (CR) Total Knee Replacement…Conformis, Inc. · 2020
- Descendant · 2 generations on · 10 of its ownK210191 Identity Imprint Knee Replacement SystemConformis, Inc. · 2021 · Recalled
- Descendant · 2 generations on · 9 of its ownK212411 Identity Imprint Knee Replacement System (including Identity Imprint…Conformis, Inc. · 2021
- Descendant · 3 generations on · 8 of its ownK213389 Identity Imprint Cruciate Retaining (CR) Knee Replacement System and…Conformis, Inc. · 2021
Show all 16 generations
- Root · 16 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 15 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
- 14 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
- 13 generations backK050327 E-Poly (Vitamin E) Acetabular LinersBiomet, Inc. · 2005
- 12 generations backK070364 100KGY E-Poly Maxrom Acetabular LinersBiomet, Inc. · 2007
- 11 generations backK080528 E-Poly Tibial BearingsBiomet Orthopedics, Inc. · 2008
- 10 generations backK091956 Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model…Encore Medical L.P. · 2010 · Recalled
- 9 generations backK103223 Highly Cross-Linked Vitamin E Uhmwpe Tibial InsertsEncore Medical L.P. · 2010
- 8 generations backK122870 Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 2013
- 7 generations backK131019 Itotal Cruciate Retaining (C) Knee Replacement SystemConformis, Inc. · 2013
- 6 generations backK140423 Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 2014 · Recalled
- 5 generations backK142161 Itotal Cruciate Retaining (CR) Knee Replacement System, Itotal…Conformis, Inc. · 2014 · Recalled
- 4 generations backK152704 iTotal Posterior Stabilized Knee Replacement System, iTotal Cruciate…Conformis, Inc. · 2015
- 3 generations backK160025 iTotal Posterior Stabilized (PS) Knee Replacement System, iTotal…Conformis, Inc. · 2016 · Recalled
- 2 generations backK161366 ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System…Conformis, Inc. · 2016
- 1 generation backK180906 Conformis iTotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 2018 · Recalled
- This deviceK193105 iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee…Conformis, Inc. · 2020
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
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 · 2 generations on12descendants
- K210191Identity Imprint Knee Replacement SystemConformis, Inc. · 2021 · 2 generations on10descendants
- K212411Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc. · 2021 · 2 generations on9descendants
- K213389Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint…Conformis, Inc. · 2021 · 3 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K810258 | Proximal Fermoral Hip Replacement | Biomet, Inc. | 1981 | — |
| −15 | K974558 | Salvage/Onocology Hip and Total Femur System | Biomet, Inc. | 1998 | — |
| −14 | K032396 | Ringloc 36MM Line and Modular Femoral Heads | Biomet, Inc. | 2003 | 3 |
| −13 | K050327 | E-Poly (Vitamin E) Acetabular Liners | Biomet, Inc. | 2005 | — |
| −12 | K070364 | 100KGY E-Poly Maxrom Acetabular Liners | Biomet, Inc. | 2007 | — |
| −11 | K080528 | E-Poly Tibial Bearings | Biomet Orthopedics, Inc. | 2008 | — |
| −10 | K091956 | Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model 391/392-09_19-702_712 | Encore Medical L.P. | 2010 | 4 |
| −9 | K103223 | Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts | Encore Medical L.P. | 2010 | — |
| −8 | K122870 | Itotal Cruciate Retaining (CR) Knee Replacement System | Conformis, Inc. | 2013 | — |
| −7 | K131019 | Itotal Cruciate Retaining (C) Knee Replacement System | Conformis, Inc. | 2013 | — |
| −6 | K140423 | Itotal Cruciate Retaining (CR) Knee Replacement System | Conformis, Inc. | 2014 | 1 |
| −5 | K142161 | Itotal Cruciate Retaining (CR) Knee Replacement System, Itotal Posterior… | Conformis, Inc. | 2014 | 6 |
| −4 | K152704 | iTotal Posterior Stabilized Knee Replacement System, iTotal Cruciate Retaining… | Conformis, Inc. | 2015 | — |
| −3 | K160025 | iTotal Posterior Stabilized (PS) Knee Replacement System, iTotal Cruciate… | Conformis, Inc. | 2016 | 1 |
| −2 | K161366 | ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS) | Conformis, Inc. | 2016 | — |
| −1 | K180906 | Conformis iTotal Cruciate Retaining (CR) Knee Replacement System | Conformis, Inc. | 2018 | 4 |
| 0 (this device) | K193105 | iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee Repair… | Conformis, Inc. | 2020 | — |
| +1 | K201023 | iTotal® Identity Posterior Stabilized Knee Replacement System | Conformis, Inc. | 2020 | — |
| +2 | K203447 | iTotal Identity Cruciate Retaining (CR) Total Knee Replacement, iTotal… | Conformis, Inc. | 2020 | — |
| +2 | K210191 | Identity Imprint Knee Replacement System | Conformis, Inc. | 2021 | 1 |
| +2 | K212411 | Identity Imprint Knee Replacement System (including Identity Imprint Posterior… | Conformis, Inc. | 2021 | — |
| +3 | K213389 | Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity… | Conformis, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1984 | 1 | 0 |
| 1988 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 5 | 0 |
| 1993 | 4 | 0 |
| 1994 | 9 | 0 |
| 1995 | 11 | 0 |
| 1996 | 7 | 0 |
| 1997 | 6 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 3 | 0 |
| 2001 | 7 | 0 |
| 2002 | 7 | 0 |
| 2003 | 4 | 0 |
| 2004 | 7 | 0 |
| 2005 | 5 | 0 |
| 2006 | 3 | 0 |
| 2007 | 5 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2010 | 4 | 0 |
| 2011 | 4 | 0 |
| 2012 | 8 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2016 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 2 | 0 |
| 2021 | 5 | 0 |
| 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K180906 | Conformis iTotal Cruciate Retaining (CR) Knee Replacement SystemSummary page 8…lymerKnee Arthroplasty Implantation System; JWH, OIY, OOG Legally Marketed Predicate Device (Primary Predicate): iTotal Cruciate Retaining (CR) Knee Replacement System (K180906) (Ssecondary Predicates): iUni Unicondylar Knee Replacement System (K132640, K133256) iDuo Bicompartmental Knee Replacement Syst… | 2018 |
| * | K132640 | Iuni Unicondylar Knee Replacement SystemSummary page 8…redicate Device (Primary Predicate): iTotal Cruciate Retaining (CR) Knee Replacement System (K180906) (Ssecondary Predicates): iUni Unicondylar Knee Replacement System (K132640, K133256) iDuo Bicompartmental Knee Replacement System (K093513, K133256) iTotal Posterior Stabilized (PS) Knee Replacement Syste… | 2013 |
| * | K133256 | Itotal Cruciate Retaining, Iuni Unicondylar Knee Replacement Systems, Iduo…Summary page 8…Device (Primary Predicate): iTotal Cruciate Retaining (CR) Knee Replacement System (K180906) (Ssecondary Predicates): iUni Unicondylar Knee Replacement System (K132640, K133256) iDuo Bicompartmental Knee Replacement System (K093513, K133256) iTotal Posterior Stabilized (PS) Knee Replacement System (K16166… | 2014 |
| * | K093513 | Iduo Bicompartmental Knee Repair SystemSummary page 8…CR) Knee Replacement System (K180906) (Ssecondary Predicates): iUni Unicondylar Knee Replacement System (K132640, K133256) iDuo Bicompartmental Knee Replacement System (K093513, K133256) iTotal Posterior Stabilized (PS) Knee Replacement System (K161668) Device Description: ConforMIS knee replacement syst… | 2009 |
| * | K161668 | ConforMIS iTotal (R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS)Summary page 8…ylar Knee Replacement System (K132640, K133256) iDuo Bicompartmental Knee Replacement System (K093513, K133256) iTotal Posterior Stabilized (PS) Knee Replacement System (K161668) Device Description: ConforMIS knee replacement systems are patient-specific semi-constrained knee implants which consist of a f… | 2016 |
What descends from it? (15)
See all 151 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K201023 | iTotal® Identity Posterior Stabilized Knee Replacement System | 2020 | 14 |
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 39 years and passes through 4 companies; a new generation was cleared every 1.6 years on median.
- 67 of the 136 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 devicesJWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
The ConforMiS Unicondylar Knee Replacement System (iUni) is intended for use in one compartment of the osteoarthritic knee to replace the damaged area of the articular surface in patients with evidence of adequate healthy bone sufficient for support of the implanted components. Candidates for unicondylar knee replacement include those with: + Joint impairment due to osteoarthritis or traumatic arthritis of the knee * Previous femoral condyle or tibial…
Read the full statement (514 words)
The ConforMiS Unicondylar Knee Replacement System (iUni) is intended for use in one compartment of the osteoarthritic knee to replace the damaged area of the articular surface in patients with evidence of adequate healthy bone
sufficient for support of the implanted components.
Candidates for unicondylar knee replacement include those with:
+ Joint impairment due to osteoarthritis or traumatic
arthritis of the knee
* Previous femoral condyle or tibial plateau fracture,
creating loss of function
* Valgus or varus deformity of the knee
* 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.
The ConforMIS iDuo Bicompartmental Knee Repair System is intended for use in patients with severe knee joint pain and
disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only a single knee
compartment, such as unicondylar or patellofemoral prosthesis.
The indications for use include restoring joint function and relief of pain due to:
* Painful joint disease due to osteoarthritis
* Traumatic arthritis of the knee
» Post traumatic loss of joint function
» Failed osteotomies, hemiarthroplasties and unicondylar implants
The Duo Bicompartmental Knee Repair System may be utilized when the medial or lateral condyle and the patellofemoral
areas have been affected by one or more of the above noted conditions.
The iDuo implant is intended for cemented use only.
The iTotal PS 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, 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 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.
The iTotal 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.
https://510kreport.com/device/K193105 · printed Nov 4, 2026
Cite this page
510(k) Report. “K193105: iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee Repair System, iTotal CR Knee Replacement System, iTotal 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/K193105
Report an extraction error
Are you the manufacturer?
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