# K231233: Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRS

- Pathway: 510(k) (Special)
- Applicant: Conformis, Inc.
- Decided: May 26, 2023 after 28 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: 24 generations back to K810258 (1981). 285 ancestors in all.
No later device cites it as a predicate yet.
0 of 286 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221404: Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS), Conformis, Inc. (2022) Summary page 4.
- K210252: iTotal Identity Cruciate Retaining (CR) Knee Replacement System, iTotal Identity Posterior Stabilizing (PS) Knee Replacement System, Conformis, Inc. (2021). Our reading of the summary gave K210152, FDA’s number for Automatic Digital Blood Pressure Monitor (Aviche Shandong Medical Technology Co, Ltd.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “iTotal Identity Cruciate Retaining (CR) Knee Replacement System…”.

## Recalls of this device
- Mar 11, 2024 · Class II · Z-1591-2024: Size 5 Tibial Tray from Lot 508287 was packaged in a Size 4 box from Lot 540287. It was confirmed that Lot 540287 and Lot 508287 were swapped between the pouching and final pack.

## Indications for use
Identity Imprint CR KRS The Identity Imprint CR 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 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. Identity Imprint PS KRS The Identity Imprint 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 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 bicompartental implants • Revision procedures provided that the 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/K231233
Methodology: https://510kreport.com/methodology