# K161668: ConforMIS iTotal (R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS)

- Pathway: 510(k) (Special)
- Applicant: Conformis, Inc.
- Decided: Jul 15, 2016 after 29 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: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K810258 (1981). 112 ancestors in all.
17 later devices descend from it; 3 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)
- K160025: iTotal Posterior Stabilized (PS) Knee Replacement System, iTotal Cruciate Retaining (CR) Knee Replacement System, Conformis, Inc. (2016) Summary page 5.
- K153217: ConforMIS iTotal Posterior Stabilized Knee Replacement System, Conformis, Inc. (2016) Summary page 5.

## Most influential descendants
- 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
- K201023: iTotal® Identity Posterior Stabilized Knee Replacement System (2020), 14 descendants of its own
- K203447: iTotal Identity Cruciate Retaining (CR) Total Knee Replacement, iTotal Identity Posterior Stabilizing (PS) Total Knee Replacement (2020), 12 descendants of its own
- K210191: Identity Imprint Knee Replacement System (2021), 10 descendants of its own

## Recalls of this device
- Feb 3, 2020 · Class II · Z-1628-2020: A limited number of tibial trays were labeled with an incorrect serial number and were delivered to the wrong customer accounts.
- Jan 4, 2019 · Class II · Z-1079-2019: The labeling of the boxes and sterile pouches did not match the contents.
- Jul 24, 2017 · Class II · Z-0600-2018: Implant kit mislabeled
- Oct 31, 2016 · Class II · Z-0991-2017: iView report displayed femoral cut measurements in the incorrect unit of measure (inches vs. mm).

## Indications for use
The iTotal® PS 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, 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/K161668
Methodology: https://510kreport.com/methodology