# K122991: Itotal Cruciate Retaining (CR) Knee Replacement System

- Pathway: 510(k) (Traditional)
- Applicant: Conformis, Inc.
- Decided: Dec 20, 2012 after 85 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: 8 generations back to K911802 (1992). 31 ancestors in all.
26 later devices descend from it; 1 cites it directly.
0 of 58 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 1.
- K103117: Itotal Cruciate Retaining (CR) Knee Replacement System, Conformis, Inc. (2011) Summary page 1.
- K112780: Conformis Itotal Cruciate Retaining (CR) Knee Replacement System, Conformis, Inc. (2011) Summary page 1.
- K113378: Conformis Itotal Cruciate Retaining (CR) Knee Replacement System, Conformis, Inc. (2012) Summary page 1.
- K120068: Conformis Itotal CR Knee Replacement System (KRS), Conformis, Inc. (2012) Summary page 1.
- K120316: Itotal Cruciate Retaining (CR) Knee Replacement System, Conformis, Inc. (2012) Summary page 1.

## Most influential descendants
- K140423: Itotal Cruciate Retaining (CR) Knee Replacement System (2014), 25 descendants of its own
- 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

## 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, 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, hemniarthroplasties, and unicondylar, patellofemoral or bicompartmental implants. The implant is intended for cemented use only.

Source page: https://510kreport.com/device/K122991
Methodology: https://510kreport.com/methodology