# K160025: iTotal Posterior Stabilized (PS) Knee Replacement System, iTotal Cruciate Retaining (CR) Knee Replacement System

- Pathway: 510(k) (Special)
- Applicant: Conformis, Inc.
- Decided: Mar 7, 2016 after 61 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K810258 (1981). 110 ancestors in all.
20 later devices descend from it; 2 cite it directly.
0 of 131 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142161: Itotal Cruciate Retaining (CR) Knee Replacement System, Itotal Posterior Stabilized (PS) Knee Replacement System, Conformis, Inc. (2014) Summary page 7.
- K142404: iTotal Posterior Stabilized (PS) Knee Replacement System, Conformis, Inc. (2014) Summary page 7.
- K152704: iTotal Posterior Stabilized Knee Replacement System, iTotal Cruciate Retaining Knee Replacement System, Conformis, Inc. (2015) Summary page 7.

## Most influential descendants
- K161366: ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS) (2016), 18 descendants of its own
- K180906: Conformis iTotal Cruciate Retaining (CR) Knee Replacement System (2018), 17 descendants of its own
- K161668: ConforMIS iTotal (R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS) (2016), 17 descendants of its own
- K193105: iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee Repair System, iTotal CR Knee Replacement System, iTotal PS Knee Replacement System (2020), 15 descendants of its own
- K190562: iTotal Identity Cruciate Retaining Knee Replacement System (2019), 15 descendants of its own

## Recalls of this device
- Oct 18, 2016 · Class II · Z-0658-2017: Mislabeled: incorrect serial number on the F4 A/P cut guide iJig.

## 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 structurs 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/K160025
Methodology: https://510kreport.com/methodology