510(k) · Cleared
ClearedConformis Total Knee Repiar System (Itotal) Tibial Component: 6.0 MM Thickness
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 May 12, 2008 as substantially equivalent to K052687 (Conformis, Inc., 2006) and 2 other predicates after a 40-day review. Its family tree reaches back 6 generations to 1992.
- Decided
- May 12, 2008
- Review
- 40 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K911802 (1992). 33 ancestors in all, the oldest K880155 (1988). No later device cites it as a predicate yet.
- Root · 6 generations backK911802 Pmi (Patient Matched Implants) Hip Femoral CompBiomet, Inc. · 1992
- 5 generations backK033242 Knee Interpositional Mini-Repair System (Kimrs)Imaging Therapeutics, Inc. · 2003
- 4 generations backK043570 Unicondylar Knee Repair System / Conformis UcdConformis, Inc. · 2005 · Recalled
- 3 generations backK053488 Conformis Bicompartmental Knee Repair SystemConformis, Inc. · 2006
- 2 generations backK063432 Conformis Metal Backed Tibial Component (MBT)Conformis, Inc. · 2007 · Recalled
- 1 generation backK072368 Conformis Metal Backed Tibial ComponentConformis, Inc. · 2007 · Recalled
- This deviceK080936 Conformis Total Knee Repiar System (Itotal) Tibial Component: 6.0 MM…Conformis, Inc. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K911802 | Pmi (Patient Matched Implants) Hip Femoral Comp | Biomet, Inc. | 1992 | — |
| −5 | K033242 | Knee Interpositional Mini-Repair System (Kimrs) | Imaging Therapeutics, Inc. | 2003 | — |
| −4 | K043570 | Unicondylar Knee Repair System / Conformis Ucd | Conformis, Inc. | 2005 | 3 |
| −3 | K053488 | Conformis Bicompartmental Knee Repair System | Conformis, Inc. | 2006 | — |
| −2 | K063432 | Conformis Metal Backed Tibial Component (MBT) | Conformis, Inc. | 2007 | 3 |
| −1 | K072368 | Conformis Metal Backed Tibial Component | Conformis, Inc. | 2007 | 3 |
| 0 (this device) | K080936 | Conformis Total Knee Repiar System (Itotal) Tibial Component: 6.0 MM Thickness | Conformis, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1993 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 3 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 4 | 0 |
| 2002 | 4 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 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? (3)
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 |
|---|---|---|---|
| * | K052687 | Conformis, Inc. Total Knee Repair SystemSummary page 1…Thickness ConforMIS Total Knee ConforMIS Total Knee ConforMIS Total Knee Repair System Repair System Repair System (K052687) (K052687) (K052687) ConforMIS ConforMIS ConforMIS BiCo… | 2006 |
| * | K053488 | Conformis Bicompartmental Knee Repair SystemSummary page 1…ConforMIS BiCompartmental BiCompartmental BiCompartmental Knee Repair System Knee Repair System Knee Repair System (K053488) Polyethylene Tibial Insert (K053488) (K072368) Intended Use: Th… | 2006 |
| * | K072368 | Conformis Metal Backed Tibial ComponentSummary page 1…ee Repair System Knee Repair System Knee Repair System (K053488) Polyethylene Tibial Insert (K053488) (K072368) Intended Use: The ConforMIS Total Knee Repair System ("iTotal") is a minimally invasive, bone preserving primar… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
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 16 years and passes through 3 companies; a new generation was cleared every 1.0 years on median.
- 14 of the 33 ancestors have a recall of any class.
- 1 other device also cites its predicate K052687.
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. 2008, this device’s year, is highlighted.
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 Total Knee Repair System ("iTotal") 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 Total Knee Repair System ("iTotal") is intended only for use with bone cement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080936 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080936: Conformis Total Knee Repiar System (Itotal) Tibial Component: 6.0 MM Thickness.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080936
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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