510(k) · Cleared
Recalled · 2009Conformis Metal Backed Tibial Component (MBT)
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 16, 2007 as substantially equivalent to K043570 (Conformis, Inc., 2005) and 3 other predicates after a 123-day review. Its family tree reaches back 4 generations to 1992. 32 later devices descend from it. It has been recalled 3 times.
- Decided
- Mar 16, 2007
- Review
- 123 days
- Class
- Class II
- Product code
- HSX
- Recalls
- 3
- Predicates
- 4
Its longest line of descent runs back 4 generations to K911802 (1992). 22 ancestors in all, the oldest K880155 (1988). 32 later devices descend from it, 4 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 deviceK063432 Conformis Metal Backed Tibial Component (MBT)Conformis, Inc. · 2007
- Descendant · cites it directly · 31 of its ownK072368 Conformis Metal Backed Tibial ComponentConformis, Inc. · 2007 · Recalled
- Descendant · cites it directly · 29 of its ownK092441 Modification to: Conformis Iuni Unicondylar Knee Repair SystemConformis, Inc. · 2009
- Descendant · cites it directly · 28 of its ownK111916 Conformis Iuni Unicondylar Knee Replacement SystemConformis, Inc. · 2011
- Descendant · cites it directly · 27 of its ownK121974 Conformis Iuni Unicondylar Knee Replacement SystemConformis, Inc. · 2012
- Descendant · 2 generations on · 25 of its ownK132640 Iuni Unicondylar Knee Replacement SystemConformis, Inc. · 2013 · Recalled
Showing 5 of 32 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 32 · See all- K072368Conformis Metal Backed Tibial ComponentConformis, Inc. · 2007 · cites it directly31descendants
- K092441Modification to: Conformis Iuni Unicondylar Knee Repair SystemConformis, Inc. · 2009 · cites it directly29descendants
- K111916Conformis Iuni Unicondylar Knee Replacement SystemConformis, Inc. · 2011 · cites it directly28descendants
- K121974Conformis Iuni Unicondylar Knee Replacement SystemConformis, Inc. · 2012 · cites it directly27descendants
- K132640Iuni Unicondylar Knee Replacement SystemConformis, Inc. · 2013 · 2 generations on25descendants
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) | K063432 | Conformis Metal Backed Tibial Component (MBT) | Conformis, Inc. | 2007 | — |
| +1 | K072368 | Conformis Metal Backed Tibial Component | Conformis, Inc. | 2007 | 3 |
| +1 | K092441 | Modification to: Conformis Iuni Unicondylar Knee Repair System | Conformis, Inc. | 2009 | — |
| +1 | K111916 | Conformis Iuni Unicondylar Knee Replacement System | Conformis, Inc. | 2011 | — |
| +1 | K121974 | Conformis Iuni Unicondylar Knee Replacement System | Conformis, Inc. | 2012 | — |
| +2 | K132640 | Iuni Unicondylar Knee Replacement System | Conformis, Inc. | 2013 | 3 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1993 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K043570 | Unicondylar Knee Repair System / Conformis UcdSummary page 2…s ConforMIS UniCondylar DePuy Preservation ConforMIS UniCondylar Knee Repair System Unicondylar Knee Knee Repair System (K043570) (K040268) (K043570) ConforMIS Link Endo-Model Sled Confo… | 2005 |
| * | K053488 | Conformis Bicompartmental Knee Repair SystemSummary page 2…rMIS BiCompartmental Uni-Knee BiCompartmental Knee Repair System (K954186) Knee Repair System (K053488) (K053488) DePuy Pres… | 2006 |
| * | K040268 | Depuy Preservation Unicondylar TibiaSummary page 2…DePuy Preservation ConforMIS UniCondylar Knee Repair System Unicondylar Knee Knee Repair System (K043570) (K040268) (K043570) ConforMIS Link Endo-Model Sled ConforMIS BiCompartmental… | 2004 |
| * | K954186 | Sled Unicompartment Knee SystemSummary page 2…Link Endo-Model Sled ConforMIS BiCompartmental Uni-Knee BiCompartmental Knee Repair System (K954186) Knee Repair System (K053488) (K053488)… | 1996 |
What descends from it? (32)
See all 324 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 |
|---|---|---|---|---|
| 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 15 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
- 8 of the 22 ancestors have a recall of any class.
- Of its descendants, K072368 (Conformis, Inc., 2007) has gone furthest, with 31 descendants of its own.
- 8 other devices also cite its predicate K043570.
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. 2007, 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 metal backed tibial component is intended for use with the ConforMIS Unicondylar Knee Repair System and the ConforMIS BiCompartmental Knee Repair Systems, 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 metal backed tibial component is intended only for use with bone cement
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063432 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063432: Conformis Metal Backed Tibial Component (MBT).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063432
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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