510(k) · Cleared
ClearediTotal Identity Cruciate Retaining (CR) Knee Replacement System, iTotal Identity Posterior Stabilizing (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 Feb 17, 2021 after a 19-day review. The summary cites 2 numbers, none of which could be confirmed as its predicate (see the table below). 6 later devices descend from it.
- Decided
- Feb 17, 2021
- Review
- 19 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 2
6 later devices descend from it, 3 citing it directly.
- This deviceK210252 iTotal Identity Cruciate Retaining (CR) Knee Replacement System…Conformis, Inc. · 2021
- Descendant · cites it directly · 4 of its ownK210809 iTotal® Identity™ Cruciate Retaining (CR) Knee Replacement System…Conformis, Inc. · 2021 · Recalled
- Descendant · cites it directly · 2 of its ownK230846 iTotal Identity Knee Replacement System; Identity Imprint Knee…Conformis, Inc. · 2023
- Descendant · 2 generations on · 1 of its ownK230844 Identity Imprint Cruciate Retaining (CR) Knee Replacement System…Conformis, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK243768 iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement…Restor3D, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK232426 Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement…Conformis, Inc. · 2023
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K210809iTotal® Identity™ Cruciate Retaining (CR) Knee Replacement System (KRS)Conformis, Inc. · 2021 · cites it directly4descendants
- K230846iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement SystemConformis, Inc. · 2023 · cites it directly2descendants
- K230844Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate…Conformis, Inc. · 2023 · 2 generations on1descendant
- K243768iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement SystemRestor3D, Inc. · 2025 · 2 generations on0descendants
- K232426Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with…Conformis, Inc. · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K210252 | iTotal Identity Cruciate Retaining (CR) Knee Replacement System, iTotal… | Conformis, Inc. | 2021 | — |
| +1 | K210809 | iTotal® Identity™ Cruciate Retaining (CR) Knee Replacement System (KRS) | Conformis, Inc. | 2021 | 1 |
| +1 | K230846 | iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement… | Conformis, Inc. | 2023 | — |
| +2 | K230844 | Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with… | Conformis, Inc. | 2023 | — |
| +2 | K243768 | iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement System | Restor3D, Inc. | 2025 | — |
| +2 | K232426 | Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS)… | Conformis, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2023 | 4 | 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? (2)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K203447 | FDA’s K203447 is iTotal Identity Cruciate Retaining (CR) Total Knee Replacement, iTotal… Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2020 |
| Kept off the family tree | K193105 | FDA’s K193105 is iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee Repair… Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2020 |
What descends from it? (6)
3 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?
- Of its descendants, K210809 (Conformis, Inc., 2021) has gone furthest, with 4 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?
The iTotal Identity 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 compartments, such as a unicondylar, patellofemoral or bicompartmental prosthesis. The Indications for Use include: - Painful joint disease due to osteoarthritis…
Read the full statement (266 words)
The iTotal Identity 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 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 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 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.
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/K210252 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210252: iTotal Identity Cruciate Retaining (CR) Knee Replacement System, iTotal Identity Posterior Stabilizing (PS) 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/K210252
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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