# K142161: Itotal Cruciate Retaining (CR) Knee Replacement System, Itotal Posterior Stabilized (PS) Knee Replacement System

- Pathway: 510(k) (Traditional)
- Applicant: Conformis, Inc.
- Decided: Nov 14, 2014 after 100 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: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K810258 (1981). 107 ancestors in all.
24 later devices descend from it; 4 cite it directly.
0 of 132 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140423: Itotal Cruciate Retaining (CR) Knee Replacement System, Conformis, Inc. (2014) Summary page 7.
- K140833: Itotal Posterior Stabilized (PS) Knee Replacement System, Conformis, Inc. (2014) Summary page 7.

## Most influential descendants
- 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
- K180906: Conformis iTotal Cruciate Retaining (CR) Knee Replacement System (2018), 17 descendants of its own

## Recalls of this device
- Jan 28, 2016 · Class II · Z-1070-2016: Incorrect femoral component distributed
- Aug 31, 2015 · Class II · Z-0144-2016: May contain small amounts of ethylene glycol residue
- Aug 31, 2015 · Class II · Z-0141-2016: May contain small amounts of ethylene glycol residue
- Aug 31, 2015 · Class II · Z-0146-2016: May contain small amounts of ethylene glycol residue
- Aug 31, 2015 · Class II · Z-0147-2016: May contain small amounts of ethylene glycol residue
- Aug 31, 2015 · Class II · Z-0145-2016: May contain small amounts of ethylene glycol residue

## 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. The iTotal PS 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, polyarthritis or osteonecrosis of the knee. Post traumatic loss of joint function. Moderate varus, valgus or flexion deformity. 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/K142161
Methodology: https://510kreport.com/methodology