# K210252: iTotal Identity Cruciate Retaining (CR) Knee Replacement System, iTotal Identity Posterior Stabilizing (PS) Knee Replacement System

- Pathway: 510(k) (Special)
- Applicant: Conformis, Inc.
- Decided: Feb 17, 2021 after 19 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
No predicates in its family tree.
6 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites 2 numbers, none of which could be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K203447: iTotal Identity Cruciate Retaining (CR) Total Knee Replacement, iTotal Identity Posterior Stabilizing (PS) Total Knee Replacement, Conformis, Inc. (2020). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K193105: iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee Repair System, iTotal CR Knee Replacement System, iTotal PS Knee Replacement System, Conformis, Inc. (2020). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K210809: iTotal® Identity™ Cruciate Retaining (CR) Knee Replacement System (KRS) (2021), 4 descendants of its own
- K230846: iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement System (2023), 2 descendants of its own
- K230844: Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Insert (2023), 1 descendant of its own
- K243768: iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement System (2025), 0 descendants of its own
- K232426: Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Inserts (2023), 0 descendants of its own

## Indications for use
The iTotal Identity 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 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 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 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.

Source page: https://510kreport.com/device/K210252
Methodology: https://510kreport.com/methodology