510(k) · Cleared
ClearedConformis Itotal CR Knee Replacement System (KRS)
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 Feb 3, 2012 as substantially equivalent to K094050 (Conformis, Inc., 2010) and 2 other predicates after a 25-day review. Its family tree reaches back 7 generations to 1992. 36 later devices descend from it.
- Decided
- Feb 3, 2012
- Review
- 25 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K911802 (1992). 28 ancestors in all, the oldest K880155 (1988). 36 later devices descend from it, 4 citing it directly.
- Root · 7 generations backK911802 Pmi (Patient Matched Implants) Hip Femoral CompBiomet, Inc. · 1992
- 6 generations backK033242 Knee Interpositional Mini-Repair System (Kimrs)Imaging Therapeutics, Inc. · 2003
- 5 generations backK043570 Unicondylar Knee Repair System / Conformis UcdConformis, Inc. · 2005 · Recalled
- 4 generations backK052687 Conformis, Inc. Total Knee Repair SystemConformis, Inc. · 2006
- 3 generations backK094050 Itotal CR Knee Replacement SystemConformis, Inc. · 2010
- 2 generations backK103117 Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 2011 · Recalled
- 1 generation backK112780 Conformis Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 2011
- This deviceK120068 Conformis Itotal CR Knee Replacement System (KRS)Conformis, Inc. · 2012
- Descendant · cites it directly · 33 of its ownK122870 Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 2013
- Descendant · 2 generations on · 30 of its ownK131467 Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 2013
- Descendant · 2 generations on · 30 of its ownK131019 Itotal Cruciate Retaining (C) Knee Replacement SystemConformis, Inc. · 2013
- Descendant · 3 generations on · 26 of its ownK140833 Itotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc. · 2014
- Descendant · cites it directly · 26 of its ownK122991 Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 2012
Showing 5 of 36 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 36 · See all- K122870Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 2013 · cites it directly33descendants
- K131467Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 2013 · 2 generations on30descendants
- K131019Itotal Cruciate Retaining (C) Knee Replacement SystemConformis, Inc. · 2013 · 2 generations on30descendants
- K140833Itotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc. · 2014 · 3 generations on26descendants
- K122991Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 2012 · cites it directly26descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K911802 | Pmi (Patient Matched Implants) Hip Femoral Comp | Biomet, Inc. | 1992 | — |
| −6 | K033242 | Knee Interpositional Mini-Repair System (Kimrs) | Imaging Therapeutics, Inc. | 2003 | — |
| −5 | K043570 | Unicondylar Knee Repair System / Conformis Ucd | Conformis, Inc. | 2005 | 3 |
| −4 | K052687 | Conformis, Inc. Total Knee Repair System | Conformis, Inc. | 2006 | — |
| −3 | K094050 | Itotal CR Knee Replacement System | Conformis, Inc. | 2010 | — |
| −2 | K103117 | Itotal Cruciate Retaining (CR) Knee Replacement System | Conformis, Inc. | 2011 | 1 |
| −1 | K112780 | Conformis Itotal Cruciate Retaining (CR) Knee Replacement System | Conformis, Inc. | 2011 | — |
| 0 (this device) | K120068 | Conformis Itotal CR Knee Replacement System (KRS) | Conformis, Inc. | 2012 | — |
| +1 | K122870 | Itotal Cruciate Retaining (CR) Knee Replacement System | Conformis, Inc. | 2013 | — |
| +2 | K131467 | Itotal Cruciate Retaining (CR) Knee Replacement System | Conformis, Inc. | 2013 | — |
| +2 | K131019 | Itotal Cruciate Retaining (C) Knee Replacement System | Conformis, Inc. | 2013 | — |
| +3 | K140833 | Itotal Posterior Stabilized (PS) Knee Replacement System | Conformis, Inc. | 2014 | — |
| +1 | K122991 | Itotal Cruciate Retaining (CR) Knee Replacement System | Conformis, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1993 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2013 | 4 | 0 |
| 2014 | 6 | 0 |
| 2015 | 1 | 0 |
| 2016 | 5 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 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? (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 |
|---|---|---|---|
| * | K094050 | Itotal CR Knee Replacement SystemSummary page 1…Product Code: JWH, QOG (Predicate Device) Regulation Number: 21 CFR 888.3560 510(k) number: K094050, K1 03117 and K1 12780 Traditional 510(k) - Modified iTotal® CR Knee Replacement System - iTotal FernJigs Page 20 of 80… | 2010 |
| * | K103117 | Itotal Cruciate Retaining (CR) Knee Replacement SystemSummary page 1…Product Code: JWH, QOG (Predicate Device) Regulation Number: 21 CFR 888.3560 510(k) number: K094050, K1 03117 and K1 12780 Traditional 510(k) - Modified iTotal® CR Knee Replacement System - iTotal FernJigs Page 20 of 80 === Page 2… | 2011 |
| * | K112780 | Conformis Itotal Cruciate Retaining (CR) Knee Replacement SystemSummary page 1…: JWH, QOG (Predicate Device) Regulation Number: 21 CFR 888.3560 510(k) number: K094050, K1 03117 and K1 12780 Traditional 510(k) - Modified iTotal® CR Knee Replacement System - iTotal FernJigs Page 20 of 80… | 2011 |
What descends from it? (36)
See all 364 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 20 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
- 12 of the 28 ancestors have a recall of any class.
- Of its descendants, K122870 (Conformis, Inc., 2013) has gone furthest, with 33 descendants of its own.
- 7 other devices also cite its predicate K094050.
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. 2012, 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 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, patello-femoral or bi-compartmental prosthesis. The indications for use include: * Painful joint disease due to osteoarthritis, traumatic arthritis…
Read the full statement (124 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, patello-femoral or bi-compartmental 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, hemniarthoplasties, and unicondylar, patello-femoral or bi-compartmental implants.
The iTotal CR KRS is intended for cemented use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120068 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120068: Conformis Itotal CR Knee Replacement System (KRS).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120068
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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