# K122870: Itotal Cruciate Retaining (CR) Knee Replacement System

- Pathway: 510(k) (Traditional)
- Applicant: Conformis, Inc.
- Decided: Jan 14, 2013 after 117 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 K810258 (1981). 74 ancestors in all.
33 later devices descend from it; 5 cite it directly.
0 of 108 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120316: 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 2.
- K113378: Conformis Itotal Cruciate Retaining (CR) Knee Replacement System, Conformis, Inc. (2012) Summary page 2.
- K112780: Conformis Itotal Cruciate Retaining (CR) Knee Replacement System, Conformis, Inc. (2011) Summary page 2.
- K103117: Itotal Cruciate Retaining (CR) Knee Replacement System, Conformis, Inc. (2011) Summary page 2.
- K094050: Itotal CR Knee Replacement System, Conformis, Inc. (2010) Summary page 2.
- K080528: E-Poly Tibial Bearings, Biomet Orthopedics, Inc. (2008) Summary page 2.
- K113756: Highly Cross Linked VE Central Peg Patella Highly Cross Linked VE Tri-Peg Patella Highly Cross Linked VE Metal Backed PA, Encore Medical L.P. (2012) Summary page 3.
- K103223: Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Encore Medical L.P. (2010) Summary page 3.
- K091956: Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model 391/392-09_19-702_712, Encore Medical L.P. (2010) Summary page 3.

## Most influential descendants
- 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
- K140833: Itotal Posterior Stabilized (PS) Knee Replacement System (2014), 26 descendants of its own
- K140423: Itotal Cruciate Retaining (CR) Knee Replacement System (2014), 25 descendants of its own
- K142404: iTotal Posterior Stabilized (PS) Knee Replacement System (2014), 24 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, 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. The implant is intended for cemented use only.

Source page: https://510kreport.com/device/K122870
Methodology: https://510kreport.com/methodology