# K080936: Conformis Total Knee Repiar System (Itotal) Tibial Component: 6.0 MM Thickness

- Pathway: 510(k) (Traditional)
- Applicant: Conformis, Inc.
- Decided: May 12, 2008 after 40 days
- Product code: JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K911802 (1992). 33 ancestors in all.
No later device cites it as a predicate yet.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052687: Conformis, Inc. Total Knee Repair System, Conformis, Inc. (2006) Summary page 1.
- K053488: Conformis Bicompartmental Knee Repair System, Conformis, Inc. (2006) Summary page 1.
- K072368: Conformis Metal Backed Tibial Component, Conformis, Inc. (2007) Summary page 1.

## Indications for use
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.

Source page: https://510kreport.com/device/K080936
Methodology: https://510kreport.com/methodology