# K112780: Conformis Itotal Cruciate Retaining (CR) Knee Replacement System

- Pathway: 510(k) (Traditional)
- Applicant: Conformis, Inc.
- Decided: Dec 15, 2011 after 80 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). 27 ancestors in all.
38 later devices descend from it; 5 cite it directly.
0 of 66 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K094050: Itotal CR Knee Replacement System, Conformis, Inc. (2010) Summary page 3.
- K103117: Itotal Cruciate Retaining (CR) Knee Replacement System, Conformis, Inc. (2011) Summary page 3.

## Most influential descendants
- K120316: Itotal Cruciate Retaining (CR) Knee Replacement System (2012), 36 descendants of its own
- K120068: Conformis Itotal CR Knee Replacement System (KRS) (2012), 36 descendants of its own
- K122870: Itotal Cruciate Retaining (CR) Knee Replacement System (2013), 33 descendants of its own
- K131467: Itotal Cruciate Retaining (CR) Knee Replacement System (2013), 30 descendants of its own
- K131019: Itotal Cruciate Retaining (C) Knee Replacement System (2013), 30 descendants of its own

## Indications for use
The iTotal® CR Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patello-femoral or bi-compartmental prosthesis. The Indications for Use include: o Painful joint disease due to osteoarthritis, traumatic arthritis, rheumatoid arthritis or osteonecrosis of the knee. o Post traumatic loss of joint function. o Moderate varus, valgus or flexion deformity in which the ligamentous structures can be returned to adequate function and stability. o Failed osteotomies, hemiarthroplasties, and unicondylar, patello-femoral or bi-compartmental implants. The implant is intended for cemented use only.

Source page: https://510kreport.com/device/K112780
Methodology: https://510kreport.com/methodology