# K180906: Conformis iTotal Cruciate Retaining (CR) Knee Replacement System

- Pathway: 510(k) (Special)
- Applicant: Conformis, Inc.
- Decided: May 16, 2018 after 40 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: 15 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)
- K161366: ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS), 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
- Jul 20, 2020 · Class II · Z-2849-2020: Outer box labels for kit 0469247 correct, however the boxes contained the implants and jigs for 0468920
- Feb 3, 2020 · Class II · Z-1627-2020: A limited number of tibial trays were labeled with an incorrect serial number and were delivered to the wrong customer accounts.
- Oct 25, 2019 · Class II · Z-0672-2020: Medial and lateral polyethylene inserts did not securely fit into the cobalt chrome tray implant.
- Dec 3, 2018 · Class II · Z-1108-2019: The kits were prepared with incorrect patient ID labels and may contain incorrect components.

## Indications for use
The iTotal Cruciate Retaining (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.

Source page: https://510kreport.com/device/K180906
Methodology: https://510kreport.com/methodology