510(k) · Cleared
ClearedConformis, Inc. Total Knee Repair System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Conformis, Inc. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Aug 31, 2006 as substantially equivalent to K033242 (Imaging Therapeutics, Inc., 2003) and 4 other predicates after a 337-day review. Its family tree reaches back 3 generations to 1992. 43 later devices descend from it.
- Decided
- Aug 31, 2006
- Review
- 337 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 3 generations to K911802 (1992). 19 ancestors in all, the oldest K880155 (1988). 43 later devices descend from it, 2 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 deviceK052687 Conformis, Inc. Total Knee Repair SystemConformis, Inc. · 2006
- Descendant · cites it directly · 41 of its ownK094050 Itotal CR Knee Replacement SystemConformis, Inc. · 2010
- Descendant · 2 generations on · 40 of its ownK103117 Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 2011 · Recalled
- Descendant · 2 generations on · 38 of its ownK112780 Conformis Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 2011
- Descendant · 2 generations on · 36 of its ownK120316 Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 2012
- Descendant · 2 generations on · 36 of its ownK113378 Conformis Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 2012
Showing 5 of 43 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 43 · See all- K094050Itotal CR Knee Replacement SystemConformis, Inc. · 2010 · cites it directly41descendants
- K103117Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 2011 · 2 generations on40descendants
- K112780Conformis Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 2011 · 2 generations on38descendants
- K120316Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 2012 · 2 generations on36descendants
- K113378Conformis Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 2012 · 2 generations on36descendants
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) | K052687 | Conformis, Inc. Total Knee Repair System | Conformis, Inc. | 2006 | — |
| +1 | K094050 | Itotal CR Knee Replacement System | Conformis, Inc. | 2010 | — |
| +2 | K103117 | Itotal Cruciate Retaining (CR) Knee Replacement System | Conformis, Inc. | 2011 | 1 |
| +2 | K112780 | Conformis Itotal Cruciate Retaining (CR) Knee Replacement System | Conformis, Inc. | 2011 | — |
| +2 | K120316 | Itotal Cruciate Retaining (CR) Knee Replacement System | Conformis, Inc. | 2012 | — |
| +2 | K113378 | Conformis 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 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2004 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 5 | 0 |
| 2013 | 4 | 0 |
| 2014 | 6 | 0 |
| 2015 | 1 | 0 |
| 2016 | 5 | 0 |
| 2018 | 1 | 0 |
| 2019 | 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 JWH? 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 JWH device
- #1 K221479 Persona Personalized Knee Systemscore 22.4 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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…ological Characteristics Indications for Use • ConforMIS Knee Interpositional * Biomet Anatomic Total Knee Device (K033242) Prosthesis(K000978) * ConforMIS Unicompartmental * Advance® Total Knee s… | 2003 |
| * | K043570 | Unicondylar Knee Repair System / Conformis UcdSummary page 2…e (K033242) Prosthesis(K000978) * ConforMIS Unicompartmental * Advance® Total Knee system (K974328) (K043570) * Alaron Surgical Active Knee® System… | 2005 |
| * | K000978 | Anatomic Total Knee ProsthesisSummary page 2…ations for Use • ConforMIS Knee Interpositional * Biomet Anatomic Total Knee Device (K033242) Prosthesis(K000978) * ConforMIS Unicompartmental * Advance® Total Knee system (K974328) (K043570)… | 2000 |
| * | K974328 | Advance Total Knee SystemSummary page 2…Knee Device (K033242) Prosthesis(K000978) * ConforMIS Unicompartmental * Advance® Total Knee system (K974328) (K043570) * Alaron Surgical Active Knee® System… | 1998 |
| * | K021740 | Total Knee Cemented, Semi-ConstrainedSummary page 2…ystem (K974328) (K043570) * Alaron Surgical Active Knee® System (K021740) INTENDED USE The ConforMIS Tri-Compartmental Resurfacing (tCR) Device is intended for use in patients with severe knee… | 2002 |
What descends from it? (43)
See all 432 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)
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 1.5 years on median.
- 6 of the 19 ancestors have a recall of any class.
- Of its descendants, K094050 (Conformis, Inc., 2010) has gone furthest, with 41 descendants of its own.
- 4 other devices also cite its predicate K033242.
How does its category compare?
All JWH devicesJWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JWH
20in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JWH
55in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JWH
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JWH
9,306in 2025
MAUDE reports naming product code JWH, 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 | 18 | 74 | 14 | 1,305 |
| 2008 | 17 | 81 | 10 | 1,483 |
| 2009 | 11 | 168 | 109 | 1,870 |
| 2010 | 19 | 85 | 32 | 3,286 |
| 2011 | 25 | 87 | 27 | 5,133 |
| 2012 | 33 | 85 | 85 | 5,203 |
| 2013 | 31 | 128 | 31 | 6,135 |
| 2014 | 33 | 98 | 13 | 6,722 |
| 2015 | 27 | 87 | 11 | 6,881 |
| 2016 | 18 | 88 | 17 | 7,586 |
| 2017 | 25 | 118 | 61 | 12,263 |
| 2018 | 25 | 90 | 14 | 14,071 |
| 2019 | 28 | 133 | 5 | 14,987 |
| 2020 | 22 | 59 | 2 | 12,592 |
| 2021 | 24 | 61 | 8 | 9,408 |
| 2022 | 17 | 56 | 12 | 8,364 |
| 2023 | 20 | 57 | 67 | 8,947 |
| 2024 | 19 | 89 | 7 | 10,828 |
| 2025 | 20 | 55 | 2 | 9,306 |
| 2026 | 12 | 63 | 4 | — |
What is it indicated for?
The ConforMIS Tri-compartmental Resurfacing Device (tCR)is a minimally invasive, bone preserving primary total knee system intended 'for use in patients with severe knee joint pain and disability. The indications for use include restoring joint function and relief of pain due to:
* Painful joint disease due to osteoarthritis, traumatic arthritis, rheumatoid arthritis of the knee
• Post traumatic loss of joint function
* Mild to moderate valgus or varus deformity of the knee
The ConforMIS Tri-compartmental Resurfacing (tCR) Device is intended only for use with bone cement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052687 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052687: Conformis, Inc. Total 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/K052687
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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