510(k) · Cleared
ClearedConformis 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 Mar 9, 2006 as substantially equivalent to K033242 (Imaging Therapeutics, Inc., 2003) and 3 other predicates after an 84-day review. Its family tree reaches back 3 generations to 1992. 35 later devices descend from it.
- Decided
- Mar 9, 2006
- Review
- 84 days
- Class
- Class II
- Product code
- NPJ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K911802 (1992). 17 ancestors in all, the oldest K880155 (1988). 35 later devices descend from it, 5 citing it directly.
- Root · 3 generations backK911802 Pmi (Patient Matched Implants) Hip Femoral CompBiomet, Inc. · 1992
- 2 generations backK033242 Knee Interpositional Mini-Repair System (Kimrs)Imaging Therapeutics, Inc. · 2003
- 1 generation backK043570 Unicondylar Knee Repair System / Conformis UcdConformis, Inc. · 2005 · Recalled
- This deviceK053488 Conformis Bicompartmental Knee Repair SystemConformis, Inc. · 2006
- Descendant · cites it directly · 32 of its ownK063432 Conformis Metal Backed Tibial Component (MBT)Conformis, Inc. · 2007 · Recalled
- Descendant · cites it directly · 31 of its ownK072368 Conformis Metal Backed Tibial ComponentConformis, Inc. · 2007 · Recalled
- Descendant · cites it directly · 30 of its ownK072586 Conformis Uni-Condylar Knee SystemConformis, Inc. · 2007
- Descendant · 2 generations on · 29 of its ownK092441 Modification to: Conformis Iuni Unicondylar Knee Repair SystemConformis, Inc. · 2009
- Descendant · 2 generations on · 28 of its ownK111916 Conformis Iuni Unicondylar Knee Replacement SystemConformis, Inc. · 2011
Showing 5 of 35 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 35 · See all- K063432Conformis Metal Backed Tibial Component (MBT)Conformis, Inc. · 2007 · cites it directly32descendants
- K072368Conformis Metal Backed Tibial ComponentConformis, Inc. · 2007 · cites it directly31descendants
- K072586Conformis Uni-Condylar Knee SystemConformis, Inc. · 2007 · cites it directly30descendants
- K092441Modification to: Conformis Iuni Unicondylar Knee Repair SystemConformis, Inc. · 2009 · 2 generations on29descendants
- K111916Conformis Iuni Unicondylar Knee Replacement SystemConformis, Inc. · 2011 · 2 generations on28descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K911802 | Pmi (Patient Matched Implants) Hip Femoral Comp | Biomet, Inc. | 1992 | — |
| −2 | K033242 | Knee Interpositional Mini-Repair System (Kimrs) | Imaging Therapeutics, Inc. | 2003 | — |
| −1 | K043570 | Unicondylar Knee Repair System / Conformis Ucd | Conformis, Inc. | 2005 | 3 |
| 0 (this device) | K053488 | Conformis Bicompartmental Knee Repair System | Conformis, Inc. | 2006 | — |
| +1 | K063432 | Conformis Metal Backed Tibial Component (MBT) | Conformis, Inc. | 2007 | 3 |
| +1 | K072368 | Conformis Metal Backed Tibial Component | Conformis, Inc. | 2007 | 3 |
| +1 | K072586 | Conformis Uni-Condylar Knee System | Conformis, Inc. | 2007 | — |
| +2 | K092441 | Modification to: Conformis Iuni Unicondylar Knee Repair System | Conformis, Inc. | 2009 | — |
| +2 | K111916 | Conformis Iuni Unicondylar Knee Replacement System | Conformis, Inc. | 2011 | — |
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 |
|---|---|---|
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 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 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? (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…are: Technological Characteristics Indications for Use * Imaging TherapeuticsTM Knee Interpositional * Smith & Nephew Hybrid Knee Femoral Device (K033242) Components (K042896) * ConforMIS Unicondylar Knee (K043 570) * ConforMIS Unicondylar Knee… | 2003 |
| * | K042896 | Smith & Nephew Hybrid Knee FemoralSummary page 2…Indications for Use * Imaging TherapeuticsTM Knee Interpositional * Smith & Nephew Hybrid Knee Femoral Device (K033242) Components (K042896) * ConforMIS Unicondylar Knee (K043 570) * ConforMIS Unicondylar Knee (… | 2005 |
| * | K043570 | Unicondylar Knee Repair System / Conformis UcdSummary page 2…euticsTM Knee Interpositional * Smith & Nephew Hybrid Knee Femoral Device (K033242) Components (K042896) * ConforMIS Unicondylar Knee (K043 570) * ConforMIS Unicondylar Knee (K043570)… | 2005 |
| * | K002356 | Natural-Knee II Patellofemoral Joint ProsthesisSummary page 2…(K043570) · Natrual Knee® - Sulzer Orthopedics (K002356) INTENDED USE The ConforMIS, Inc., BiCompartmental Knee Repair System is intended for use in patients with severe knee… | 2000 |
What descends from it? (35)
See all 355 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| 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 |
| K093513 | Iduo Bicompartmental Knee Repair System | 2009 | 17 |
| K080936 | Conformis Total Knee Repiar System (Itotal) Tibial Component: 6.0 MM Thickness | 2008 | 0 |
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?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
- 5 of the 17 ancestors have a recall of any class.
- Of its descendants, K063432 (Conformis, Inc., 2007) has gone furthest, with 32 descendants of its own.
- 4 other devices also cite its predicate K033242.
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.
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 ConforMIS, Inc., BiCompartmental Knee Repair System 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 include restoring joint function and relief of pain due to: * painful joint disease due to osteoarthritis, traumatic arthritis or…
Read the full statement (132 words)
The ConforMIS, Inc., BiCompartmental Knee Repair System 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 include 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, hemiarthoplasties and unicondylar implants.
The BiCompartmental Knee Repair System may be utilized when the medial or lateral condyle and the patellofemoral areas have been affected by one or more of these conditions.
The ConforMIS, Inc., BiCompartmental Knee Repair System is intended only for use with bone cement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053488 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053488: Conformis Bicompartmental Knee Repair System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053488
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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