# K142404: iTotal Posterior Stabilized (PS) Knee Replacement System

- Pathway: 510(k) (Special)
- Applicant: Conformis, Inc.
- Decided: Dec 11, 2014 after 106 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: 2 (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). 104 ancestors in all.
24 later devices descend from it; 3 cite it directly.
0 of 129 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140833: Itotal Posterior Stabilized (PS) Knee Replacement System, Conformis, Inc. (2014) Summary page 5.

## 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
- Aug 31, 2015 · Class II · Z-0141-2016: May contain small amounts of ethylene glycol residue
- Aug 31, 2015 · Class II · Z-0147-2016: May contain small amounts of ethylene glycol residue

## Indications for use
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/K142404
Methodology: https://510kreport.com/methodology