# K223316: Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate Retaining Total Knee Replacement System

- Pathway: 510(k) (Traditional)
- Applicant: Conformis, Inc.
- Decided: Jul 21, 2023 after 266 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: 24 generations back to K810258 (1981). 316 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 319 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141635: Arthrex Ibalance Tka System, Arthrex, Inc. (2014) Summary page 5.
- 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 5.

## Most influential descendants
- 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 Identity Imprint Porous Cruciate Retaining Total 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 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 Identity Imprint Porous Cruciate Retaining Total Knee Replacement System is intended for uncemented use, but porous implants may be used with cement if desired by the surgeon.

Source page: https://510kreport.com/device/K223316
Methodology: https://510kreport.com/methodology