# K232426: Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Inserts

- Pathway: 510(k) (Special)
- Applicant: Conformis, Inc.
- Decided: Sep 8, 2023 after 28 days
- Product code: MBH (Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3565
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 25 generations back to K810258 (1981). 321 ancestors in all.
No later device cites it as a predicate yet.
0 of 322 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223316: Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate Retaining Total Knee Replacement System, Conformis, Inc. (2023) Summary page 5.
- K230844: Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Insert, Conformis, Inc. (2023) Summary page 5.
- K230846: iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement System, Conformis, Inc. (2023) Summary page 5.

## Indications for use
The Identity TM Imprint TM Porous Cruciate Retaining (CR) Total Knee Replacement System with Cruciate Sacrificing (CS) Insert 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 The Ildentity M Imprint TM Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Insert is intended for uncemented use, but porous implants may be used with cement if desired by the surgeon. The CS (cruciate sacrificing) insert option should be utilized when additional anterior-posterior constraint is desired.

Source page: https://510kreport.com/device/K232426
Methodology: https://510kreport.com/methodology