510(k) · Cleared
Recalled · Class II · 2015Iuni Unicondylar Knee Replacement System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Conformis, Inc. · HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
Cleared on Dec 5, 2013 as substantially equivalent to K121974 (Conformis, Inc., 2012) and 1 other predicate after a 104-day review. Its family tree reaches back 9 generations to 1992. 25 later devices descend from it. It has been recalled 3 times.
- Decided
- Dec 5, 2013
- Review
- 104 days
- Class
- Class II
- Product code
- HSX
- Recalls
- 3
- Predicates
- 2
Its longest line of descent runs back 9 generations to K911802 (1992). 34 ancestors in all, the oldest K880155 (1988). 25 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK911802 Pmi (Patient Matched Implants) Hip Femoral CompBiomet, Inc. · 1992
- 5 generations between
- 3 generations backK092441 Modification to: Conformis Iuni Unicondylar Knee Repair SystemConformis, Inc. · 2009
- 2 generations backK111916 Conformis Iuni Unicondylar Knee Replacement SystemConformis, Inc. · 2011
- 1 generation backK121974 Conformis Iuni Unicondylar Knee Replacement SystemConformis, Inc. · 2012
- This deviceK132640 Iuni Unicondylar Knee Replacement SystemConformis, Inc. · 2013
- 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
- Descendant · 3 generations on · 9 of its ownK212411 Identity Imprint Knee Replacement System (including Identity Imprint…Conformis, Inc. · 2021
Show all 9 generations
- Root · 9 generations backK911802 Pmi (Patient Matched Implants) Hip Femoral CompBiomet, Inc. · 1992
- 8 generations backK033242 Knee Interpositional Mini-Repair System (Kimrs)Imaging Therapeutics, Inc. · 2003
- 7 generations backK043570 Unicondylar Knee Repair System / Conformis UcdConformis, Inc. · 2005 · Recalled
- 6 generations backK053488 Conformis Bicompartmental Knee Repair SystemConformis, Inc. · 2006
- 5 generations backK063432 Conformis Metal Backed Tibial Component (MBT)Conformis, Inc. · 2007 · Recalled
- 4 generations backK072368 Conformis Metal Backed Tibial ComponentConformis, Inc. · 2007 · Recalled
- 3 generations backK092441 Modification to: Conformis Iuni Unicondylar Knee Repair SystemConformis, Inc. · 2009
- 2 generations backK111916 Conformis Iuni Unicondylar Knee Replacement SystemConformis, Inc. · 2011
- 1 generation backK121974 Conformis Iuni Unicondylar Knee Replacement SystemConformis, Inc. · 2012
- This deviceK132640 Iuni Unicondylar Knee Replacement SystemConformis, Inc. · 2013
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- 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
- K212411Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc. · 2021 · 3 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K911802 | Pmi (Patient Matched Implants) Hip Femoral Comp | Biomet, Inc. | 1992 | — |
| −8 | K033242 | Knee Interpositional Mini-Repair System (Kimrs) | Imaging Therapeutics, Inc. | 2003 | — |
| −7 | K043570 | Unicondylar Knee Repair System / Conformis Ucd | Conformis, Inc. | 2005 | 3 |
| −6 | K053488 | Conformis Bicompartmental Knee Repair System | Conformis, Inc. | 2006 | — |
| −5 | K063432 | Conformis Metal Backed Tibial Component (MBT) | Conformis, Inc. | 2007 | 3 |
| −4 | K072368 | Conformis Metal Backed Tibial Component | Conformis, Inc. | 2007 | 3 |
| −3 | K092441 | Modification to: Conformis Iuni Unicondylar Knee Repair System | Conformis, Inc. | 2009 | — |
| −2 | K111916 | Conformis Iuni Unicondylar Knee Replacement System | Conformis, Inc. | 2011 | — |
| −1 | K121974 | Conformis Iuni Unicondylar Knee Replacement System | Conformis, Inc. | 2012 | — |
| 0 (this device) | K132640 | Iuni Unicondylar Knee Replacement System | Conformis, Inc. | 2013 | — |
| +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 |
| +3 | K212411 | Identity Imprint Knee Replacement System (including Identity Imprint Posterior… | Conformis, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 4 | 0 |
| 2002 | 3 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 3 | 0 |
| 2021 | 9 | 0 |
| 2022 | 2 | 0 |
| 2023 | 5 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 HSX? 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 HSX device
- #1 K261609 Freedom Partial Knee Systemscore 15.1 · 12 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K121974 | Conformis Iuni Unicondylar Knee Replacement SystemSummary page 1…Product Code: HSX, COG Device): Regulation Number: 21 CFR 888.3520 510(k) Number: K1 21974 and K1 11916 Traditional 510(k) - Modification of the lUni Knee Replacement System - SegSuif v3.OhiUniWorks v4.0/iUni FernJig… | 2012 |
| * | K111916 | Conformis Iuni Unicondylar Knee Replacement SystemSummary page 1…HSX, COG Device): Regulation Number: 21 CFR 888.3520 510(k) Number: K1 21974 and K1 11916 Traditional 510(k) - Modification of the lUni Knee Replacement System - SegSuif v3.OhiUniWorks v4.0/iUni FernJigs v2.0… | 2011 |
What descends from it? (25)
See all 252 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-0138-2016 | Process design | May contain small amounts of ethylene glycol residue |
| Aug 31, 2015 | Class II | Z-0139-2016 | Process design | May contain small amounts of ethylene glycol residue |
| Aug 31, 2015 | Class II | Z-0140-2016 | 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 21 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
- 14 of the 34 ancestors have a recall of any class.
- Of its descendants, K193105 (Conformis, Inc., 2020) has gone furthest, with 15 descendants of its own.
- 1 other device also cites its predicate K121974.
How does its category compare?
All HSX devicesHSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · HSX
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HSX
59in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HSX
2in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HSX
175in 2025
MAUDE reports naming product code HSX, 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 | 6 | 33 | 0 | 6 |
| 2008 | 4 | 102 | 0 | 4 |
| 2009 | 2 | — | 49 | 21 |
| 2010 | 3 | 74 | 0 | 58 |
| 2011 | 1 | — | 0 | 114 |
| 2012 | 5 | 88 | 0 | 83 |
| 2013 | 2 | — | 1 | 79 |
| 2014 | 0 | — | 0 | 66 |
| 2015 | 1 | — | 0 | 57 |
| 2016 | 3 | 147 | 1 | 107 |
| 2017 | 5 | 160 | 4 | 113 |
| 2018 | 2 | — | 0 | 159 |
| 2019 | 7 | 90 | 0 | 177 |
| 2020 | 4 | 40 | 2 | 273 |
| 2021 | 7 | 81 | 0 | 240 |
| 2022 | 2 | — | 0 | 257 |
| 2023 | 1 | — | 0 | 231 |
| 2024 | 4 | 133 | 0 | 172 |
| 2025 | 4 | 59 | 0 | 175 |
| 2026 | 2 | — | 0 | — |
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 (111 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132640 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132640: Iuni Unicondylar 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/K132640
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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