510(k) · Cleared
Recalled · Class II · 2015Iduo Bicompartmental Knee Repair System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Conformis, Inc. · NPJ Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Dec 16, 2009 as substantially equivalent to K053488 (Conformis, Inc., 2006) after a 33-day review. Its family tree reaches back 4 generations to 1992. 17 later devices descend from it. It has been recalled 3 times.
- Decided
- Dec 16, 2009
- Review
- 33 days
- Class
- Class II
- Product code
- NPJ
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 4 generations to K911802 (1992). 18 ancestors in all, the oldest K880155 (1988). 17 later devices descend from it, 2 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 backK053488 Conformis Bicompartmental Knee Repair SystemConformis, Inc. · 2006
- This deviceK093513 Iduo Bicompartmental Knee Repair SystemConformis, Inc. · 2009
- Descendant · cites it directly · 16 of its ownK133256 Itotal Cruciate Retaining, Iuni Unicondylar Knee Replacement…Conformis, Inc. · 2014 · Recalled
- Descendant · cites it directly · 15 of its ownK193105 iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee…Conformis, Inc. · 2020
- Descendant · 2 generations on · 14 of its ownK201023 iTotal® Identity Posterior Stabilized Knee Replacement SystemConformis, Inc. · 2020
- Descendant · 3 generations on · 12 of its ownK203447 iTotal Identity Cruciate Retaining (CR) Total Knee Replacement…Conformis, Inc. · 2020
- Descendant · 3 generations on · 10 of its ownK210191 Identity Imprint Knee Replacement SystemConformis, Inc. · 2021 · Recalled
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K133256Itotal Cruciate Retaining, Iuni Unicondylar Knee Replacement Systems, Iduo…Conformis, Inc. · 2014 · cites it directly16descendants
- K193105iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee Repair System…Conformis, Inc. · 2020 · cites it directly15descendants
- K201023iTotal® Identity Posterior Stabilized Knee Replacement SystemConformis, Inc. · 2020 · 2 generations on14descendants
- K203447iTotal Identity Cruciate Retaining (CR) Total Knee Replacement, iTotal Identity…Conformis, Inc. · 2020 · 3 generations on12descendants
- K210191Identity Imprint Knee Replacement SystemConformis, Inc. · 2021 · 3 generations on10descendants
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 | K053488 | Conformis Bicompartmental Knee Repair System | Conformis, Inc. | 2006 | — |
| 0 (this device) | K093513 | Iduo Bicompartmental Knee Repair System | Conformis, Inc. | 2009 | — |
| +1 | K133256 | Itotal Cruciate Retaining, Iuni Unicondylar Knee Replacement Systems, Iduo… | Conformis, Inc. | 2014 | 6 |
| +1 | K193105 | iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee Repair… | Conformis, Inc. | 2020 | — |
| +2 | K201023 | iTotal® Identity Posterior Stabilized Knee Replacement System | Conformis, Inc. | 2020 | — |
| +3 | K203447 | iTotal Identity Cruciate Retaining (CR) Total Knee Replacement, iTotal… | Conformis, Inc. | 2020 | — |
| +3 | K210191 | Identity Imprint Knee Replacement System | Conformis, Inc. | 2021 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1993 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 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 NPJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K053488 | Conformis Bicompartmental Knee Repair SystemSummary page 3…equivalent to the currently marketed iDuo Bicompartmental Knee Repair System (reference K053488 cleared March 9, 2006) and other currently marketed devices. Safety and Performance:… | 2006 |
What descends from it? (17)
See all 172 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 31, 2015 | Class II | Z-0142-2016 | Process design | May contain small amounts of ethylene glycol residue |
| Aug 31, 2015 | Class II | Z-0148-2016 | Process design | May contain small amounts of ethylene glycol residue |
| Aug 31, 2015 | Class II | Z-0143-2016 | Process design | May contain small amounts of ethylene glycol residue |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 3.8 years on median.
- 5 of the 18 ancestors have a recall of any class.
- Of its descendants, K133256 (Conformis, Inc., 2014) has gone furthest, with 16 descendants of its own.
- 4 other devices also cite its predicate K053488.
How does its category compare?
All NPJ devicesNPJ Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · NPJ
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · NPJ
76in 2009
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NPJ
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NPJ
47in 2025
MAUDE reports naming product code NPJ, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 3 | 76 | 0 | 3 |
| 2010 | 0 | — | 0 | 13 |
| 2011 | 0 | — | 1 | 32 |
| 2012 | 0 | — | 0 | 72 |
| 2013 | 1 | — | 0 | 98 |
| 2014 | 0 | — | 0 | 75 |
| 2015 | 1 | — | 3 | 55 |
| 2016 | 0 | — | 1 | 93 |
| 2017 | 0 | — | 0 | 150 |
| 2018 | 0 | — | 0 | 141 |
| 2019 | 0 | — | 0 | 91 |
| 2020 | 0 | — | 0 | 65 |
| 2021 | 0 | — | 0 | 51 |
| 2022 | 0 | — | 0 | 32 |
| 2023 | 0 | — | 0 | 52 |
| 2024 | 0 | — | 0 | 44 |
| 2025 | 0 | — | 0 | 47 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The ConforMlS iDuo Bicompartmental Knee Repair System (iDuo KRS) 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 including restoring joint function and relief of pain due to: - painful joint disease due to osteoarthritis, traumatic…
Read the full statement (126 words)
The ConforMlS iDuo Bicompartmental Knee Repair System (iDuo KRS) 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 including restoring joint function and relief of pain due to:
- painful joint disease due to osteoarthritis, traumatic arthritis or rheumatoid arthritis of the knee,
- post traumatic loss of joint function
- failed osteotomies, hemiarthroplasties, and unicondylar implants.
The iDuo KRS may be utilized when the medial or lateral condyle and the patellofemoral areas have been affected by one or more of these conditions.
The iDuo KRS is intended for cemented use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093513 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093513: Iduo Bicompartmental Knee Repair System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093513
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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