510(k) · Cleared
ClearedItotal CR 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 Sep 16, 2010 as substantially equivalent to K052687 (Conformis, Inc., 2006) and 2 other predicates after a 259-day review. Its family tree reaches back 4 generations to 1992. 41 later devices descend from it.
- Decided
- Sep 16, 2010
- Review
- 259 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K911802 (1992). 25 ancestors in all, the oldest K880155 (1988). 41 later devices descend from it, 8 citing it directly.
- Root · 4 generations backK911802 Pmi (Patient Matched Implants) Hip Femoral CompBiomet, Inc. · 1992
- 3 generations backK033242 Knee Interpositional Mini-Repair System (Kimrs)Imaging Therapeutics, Inc. · 2003
- 2 generations backK043570 Unicondylar Knee Repair System / Conformis UcdConformis, Inc. · 2005 · Recalled
- 1 generation backK052687 Conformis, Inc. Total Knee Repair SystemConformis, Inc. · 2006
- This deviceK094050 Itotal CR Knee Replacement SystemConformis, Inc. · 2010
- Descendant · cites it directly · 40 of its ownK103117 Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 2011 · Recalled
- Descendant · cites it directly · 38 of its ownK112780 Conformis Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 2011
- Descendant · cites it directly · 36 of its ownK120316 Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 2012
- Descendant · cites it directly · 36 of its ownK113378 Conformis Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 2012
- Descendant · cites it directly · 36 of its ownK120068 Conformis Itotal CR Knee Replacement System (KRS)Conformis, Inc. · 2012
Showing 5 of 41 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 41 · See all- K103117Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 2011 · cites it directly40descendants
- K112780Conformis Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 2011 · cites it directly38descendants
- K120316Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 2012 · cites it directly36descendants
- K113378Conformis Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 2012 · cites it directly36descendants
- K120068Conformis Itotal CR Knee Replacement System (KRS)Conformis, Inc. · 2012 · cites it directly36descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K911802 | Pmi (Patient Matched Implants) Hip Femoral Comp | Biomet, Inc. | 1992 | — |
| −3 | K033242 | Knee Interpositional Mini-Repair System (Kimrs) | Imaging Therapeutics, Inc. | 2003 | — |
| −2 | K043570 | Unicondylar Knee Repair System / Conformis Ucd | Conformis, Inc. | 2005 | 3 |
| −1 | K052687 | Conformis, Inc. Total Knee Repair System | Conformis, Inc. | 2006 | — |
| 0 (this device) | K094050 | Itotal CR Knee Replacement System | Conformis, Inc. | 2010 | — |
| +1 | 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 | — |
| +1 | K120316 | Itotal Cruciate Retaining (CR) Knee Replacement System | Conformis, Inc. | 2012 | — |
| +1 | K113378 | Conformis Itotal Cruciate Retaining (CR) Knee Replacement System | Conformis, Inc. | 2012 | — |
| +1 | K120068 | Conformis Itotal CR Knee Replacement System (KRS) | 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 |
|---|---|---|
| 2011 | 2 | 0 |
| 2012 | 5 | 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 |
|---|---|---|---|
| * | K052687 | Conformis, Inc. Total Knee Repair SystemSummary page 2…on is substantially equivalent to the ConforMiS Tni-Compartmental Resurfacing (tCR) device (K052687), the Stryker Triathlon CR Total Knee System (K040267) and the Smith & Nephew Journey Bicr… | 2006 |
| * | K040267 | Triathlon Cruciate Retaining (CR) Total KneeSummary page 2…mpartmental Resurfacing (tCR) device (K052687), the Stryker Triathlon CR Total Knee System (K040267) and the Smith & Nephew Journey Bicruciate Stabilized Knee System (K042515) all of which a… | 2004 |
| * | K042515 | Smith & Nephew, Inc. High Performance KneeSummary page 2…tal Knee System (K040267) and the Smith & Nephew Journey Bicruciate Stabilized Knee System (K042515) all of which are cemented total knee replacement systems. See Table 5-1 below for a more… | 2005 |
What descends from it? (41)
See all 418 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K103117 | Itotal Cruciate Retaining (CR) Knee Replacement System | 2011 | 40 |
| K112780 | Conformis Itotal Cruciate Retaining (CR) Knee Replacement System | 2011 | 38 |
| K120316 | Itotal Cruciate Retaining (CR) Knee Replacement System | 2012 | 36 |
| K113378 | Conformis Itotal Cruciate Retaining (CR) Knee Replacement System | 2012 | 36 |
| K120068 | Conformis Itotal CR Knee Replacement System (KRS) | 2012 | 36 |
| K122870 | Itotal Cruciate Retaining (CR) Knee Replacement System | 2013 | 33 |
| K122991 | Itotal Cruciate Retaining (CR) Knee Replacement System | 2012 | 26 |
| K122033 | Itotal Cruciate Retaining (CR) Knee Replacement System | 2012 | 26 |
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 18 years and passes through 3 companies; a new generation was cleared every 4.0 years on median.
- 11 of the 25 ancestors have a recall of any class.
- Of its descendants, K103117 (Conformis, Inc., 2011) has gone furthest, with 40 descendants of its own.
- 1 other device also cites its predicate K052687.
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. 2010, 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/K094050 · printed Nov 6, 2026
Cite this page
510(k) Report. “K094050: Itotal 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/K094050
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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