# K140423: Itotal Cruciate Retaining (CR) Knee Replacement System

- Pathway: 510(k) (Traditional)
- Applicant: Conformis, Inc.
- Decided: May 27, 2014 after 98 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K810258 (1981). 79 ancestors in all.
25 later devices descend from it; 1 cites it directly.
0 of 105 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131467: Itotal Cruciate Retaining (CR) Knee Replacement System, Conformis, Inc. (2013) Summary page 4.
- K131019: Itotal Cruciate Retaining (C) Knee Replacement System, Conformis, Inc. (2013) Summary page 2.
- K122991: Itotal Cruciate Retaining (CR) Knee Replacement System, Conformis, Inc. (2012) Summary page 2.
- K122033: Itotal Cruciate Retaining (CR) Knee Replacement System, Conformis, Inc. (2012) Summary page 2.
- K120068: Conformis Itotal CR Knee Replacement System (KRS), Conformis, Inc. (2012) Summary page 4.

## Most influential descendants
- K142161: Itotal Cruciate Retaining (CR) Knee Replacement System, Itotal Posterior Stabilized (PS) Knee Replacement System (2014), 24 descendants of its own
- K152704: iTotal Posterior Stabilized Knee Replacement System, iTotal Cruciate Retaining Knee Replacement System (2015), 23 descendants of its own
- K160025: iTotal Posterior Stabilized (PS) Knee Replacement System, iTotal Cruciate Retaining (CR) Knee Replacement System (2016), 20 descendants of its own
- K161366: ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS) (2016), 18 descendants of its own
- K153217: ConforMIS iTotal Posterior Stabilized Knee Replacement System (2016), 18 descendants of its own

## Recalls of this device
- Nov 19, 2014 · Class II · Z-0581-2015: Incorrect serial number of tibial inserts packaged in tray may result in inserts not fitting

## Indications for use
The iTotal CR Knee Replacement System (KRS) 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, patellofemoral or bicompartmental prosthesis. The Indications for Use include: * Painful joint disease due to osteoarthritis, traumatic arthritis, rheumatoid arthritis or osteonecrosis of the knee. * Post traumatic loss of joint function. * Moderate varus, valgus or flexion deformity in which the ligamentous structures can be returned to adequate function and stability. * Failed osteotomies, hemiarthroplasties, and unicondylar, patellofemoral or bicompartmental implants. * Revision procedures provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans. This Implant Is Intended for cemented use only.

Source page: https://510kreport.com/device/K140423
Methodology: https://510kreport.com/methodology