# K140833: Itotal Posterior Stabilized (PS) Knee Replacement System

- Pathway: 510(k) (Traditional)
- Applicant: Conformis, Inc.
- Decided: Jun 30, 2014 after 89 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: 10 generations back to K810258 (1981). 103 ancestors in all.
26 later devices descend from it; 2 cite it directly.
0 of 130 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 2.
- K131019: Itotal Cruciate Retaining (C) Knee Replacement System, Conformis, Inc. (2013) Summary page 2.
- K111433: Depuy Sttune (TM) PS Knee System, DePuy Orthopaedics, Inc. (2011) Summary page 2.
- K113369: Zimmer Persona Knee System, Zimmer, Inc. (2012) Summary page 2.

## Most influential descendants
- K142404: iTotal Posterior Stabilized (PS) Knee Replacement System (2014), 24 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 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 byrthe use of a prosthetic -device that treats only one or two of the three knee compartments, such as a unicandylar, patellofemaral or blcompartmental prosthesis. The Indications for Use include: " Painful joint disease due to osteaarthrtis, traumatic arthritis, rheumatoid arthritis, polyarthritis or osteonecrosis of the knee. * Post traumatic loss of joint function. * Moderate yawus, valgus or flexion deformity. * Failed osteotomies, hemiarthroplaslies, and unicandylar, patellofemoral or bicompartmnental 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/K140833
Methodology: https://510kreport.com/methodology