510(k) · Cleared
Recalled · 2009Unicondylar Knee Repair System / Conformis Ucd
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 Mar 14, 2005 as substantially equivalent to K033242 (Imaging Therapeutics, Inc., 2003) and 2 other predicates after a 77-day review. Its family tree reaches back 2 generations to 1992. 62 later devices descend from it. It has been recalled 3 times.
- Decided
- Mar 14, 2005
- Review
- 77 days
- Class
- Class II
- Product code
- HSX
- Recalls
- 3
- Predicates
- 3
Its longest line of descent runs back 2 generations to K911802 (1992). 14 ancestors in all, the oldest K880155 (1988). 62 later devices descend from it, 9 citing it directly.
- Root · 2 generations backK911802 Pmi (Patient Matched Implants) Hip Femoral CompBiomet, Inc. · 1992
- 1 generation backK033242 Knee Interpositional Mini-Repair System (Kimrs)Imaging Therapeutics, Inc. · 2003
- This deviceK043570 Unicondylar Knee Repair System / Conformis UcdConformis, Inc. · 2005
- Descendant · cites it directly · 43 of its ownK052687 Conformis, Inc. Total Knee Repair SystemConformis, Inc. · 2006
- Descendant · 2 generations on · 41 of its ownK094050 Itotal CR Knee Replacement SystemConformis, Inc. · 2010
- Descendant · 3 generations on · 40 of its ownK103117 Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 2011 · Recalled
- Descendant · 3 generations on · 38 of its ownK112780 Conformis Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 2011
- Descendant · 3 generations on · 36 of its ownK120316 Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 2012
Showing 5 of 62 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 62 · See all- K052687Conformis, Inc. Total Knee Repair SystemConformis, Inc. · 2006 · cites it directly43descendants
- K094050Itotal CR Knee Replacement SystemConformis, Inc. · 2010 · 2 generations on41descendants
- K103117Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 2011 · 3 generations on40descendants
- K112780Conformis Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 2011 · 3 generations on38descendants
- K120316Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 2012 · 3 generations on36descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K911802 | Pmi (Patient Matched Implants) Hip Femoral Comp | Biomet, Inc. | 1992 | — |
| −1 | K033242 | Knee Interpositional Mini-Repair System (Kimrs) | Imaging Therapeutics, Inc. | 2003 | — |
| 0 (this device) | K043570 | Unicondylar Knee Repair System / Conformis Ucd | Conformis, Inc. | 2005 | — |
| +1 | K052687 | Conformis, Inc. Total Knee Repair System | Conformis, Inc. | 2006 | — |
| +2 | K094050 | Itotal CR Knee Replacement System | Conformis, Inc. | 2010 | — |
| +3 | K103117 | Itotal Cruciate Retaining (CR) Knee Replacement System | Conformis, Inc. | 2011 | 1 |
| +3 | K112780 | Conformis Itotal Cruciate Retaining (CR) Knee Replacement System | Conformis, Inc. | 2011 | — |
| +3 | K120316 | 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 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2004 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 6 | 0 |
| 2013 | 5 | 0 |
| 2014 | 6 | 0 |
| 2015 | 1 | 0 |
| 2016 | 5 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 4 | 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? (4)
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 |
|---|---|---|---|
| * | K033242 | Knee Interpositional Mini-Repair System (Kimrs)Summary page 2…cteristics Indications for Use * ConforMISTM IPD Knee Interpositional * Zimmer Unicompartmental Knee System (K033242) (K033363) * EIUS… | 2003 |
| * | K033363 | Zimmer Unicompartmental Knee SystemSummary page 2…* ConforMISTM IPD Knee Interpositional * Zimmer Unicompartmental Knee System (K033242) (K033363) * EIUS Unicompartmental Knee System… | 2004 |
| * | K033769 | Eius Unicompartmental Knee SystemSummary page 2…3) * EIUS Unicompartmental Knee System (K033769) Intended Use: The ConforMISTM Unicondylar Knee System is intended… | 2004 |
| * | — | Repicci II Unicondylar Knee Named without a submission number |
What descends from it? (62)
See all 629 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K052687 | Conformis, Inc. Total Knee Repair System | 2006 | 43 |
| K053488 | Conformis Bicompartmental Knee Repair System | 2006 | 35 |
| K063432 | Conformis Metal Backed Tibial Component (MBT) | 2007 | 32 |
| K072368 | Conformis Metal Backed Tibial Component | 2007 | 31 |
| K072586 | Conformis Uni-Condylar Knee System | 2007 | 30 |
| K092441 | Modification to: Conformis Iuni Unicondylar Knee Repair System | 2009 | 29 |
| K111916 | Conformis Iuni Unicondylar Knee Replacement System | 2011 | 28 |
| K121974 | Conformis Iuni Unicondylar Knee Replacement System | 2012 | 27 |
| K163700 | Bodycad Unicompartmental Knee System | 2017 | 8 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 23, 2009 | Not classified | Z-1623-2009 | Process control | Microscopic cracks potential for pre-mature revisions in patients implanted with the system. |
| Apr 23, 2009 | Not classified | Z-1624-2009 | Process control | Microscopic cracks potential for pre-mature revisions in patients implanted with the system. |
| Apr 23, 2009 | Not classified | Z-1622-2009 | Process control | Microscopic cracks potential for pre-mature revisions in patients implanted with the system. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 12.0 years on median.
- 4 of the 14 ancestors have a recall of any class.
- Of its descendants, K052687 (Conformis, Inc., 2006) has gone furthest, with 43 descendants of its own.
- 4 other devices also cite its predicate K033242.
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.
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 implant is intended for use in patients with:
joint impairment due to osteoarthritis or traumatic arthritis of the knee
previous tibial condyle or plateau fracture, creating loss of function
valgus or varus deformity of the knee
The ConforMIS™ unicondylar implant is for use with bone cement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043570 · printed Nov 4, 2026
Cite this page
510(k) Report. “K043570: Unicondylar Knee Repair System / Conformis Ucd.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K043570
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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