# K193105: iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee Repair System, iTotal CR Knee Replacement System, iTotal PS Knee Replacement System

- Pathway: 510(k) (Traditional)
- Applicant: Conformis, Inc.
- Decided: Mar 13, 2020 after 126 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
Longest line of descent: 16 generations back to K810258 (1981). 136 ancestors in all.
15 later devices descend from it; 1 cites it directly.
0 of 152 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180906: Conformis iTotal Cruciate Retaining (CR) Knee Replacement System, Conformis, Inc. (2018) Summary page 8.
- K132640: Iuni Unicondylar Knee Replacement System, Conformis, Inc. (2013) Summary page 8.
- K133256: Itotal Cruciate Retaining, Iuni Unicondylar Knee Replacement Systems, Iduo Bicompartmental Knee Repair System, Conformis, Inc. (2014) Summary page 8.
- K093513: Iduo Bicompartmental Knee Repair System, Conformis, Inc. (2009) Summary page 8.
- K161668: ConforMIS iTotal (R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS), Conformis, Inc. (2016) Summary page 8.

## Most influential descendants
- 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
- K212411: Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS) (2021), 9 descendants of its own
- K213389: Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint Posterior Stabilized (PS) Knee Replacement System (2021), 8 descendants of its own

## Indications for use
The ConforMiS Unicondylar Knee Replacement System (iUni) is intended for use in one compartment of the osteoarthritic knee to replace the damaged area of the articular surface in patients with evidence of adequate healthy bone sufficient for support of the implanted components. Candidates for unicondylar knee replacement include those with: + Joint impairment due to osteoarthritis or traumatic arthritis of the knee * Previous femoral condyle or tibial plateau fracture, creating loss of function * Valgus or varus deformity of the knee * 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. The ConforMIS iDuo Bicompartmental Knee Repair System is intended for use in patients with severe knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only a single knee compartment, such as unicondylar or patellofemoral prosthesis. The indications for use include restoring joint function and relief of pain due to: * Painful joint disease due to osteoarthritis * Traumatic arthritis of the knee » Post traumatic loss of joint function » Failed osteotomies, hemiarthroplasties and unicondylar implants The Duo Bicompartmental Knee Repair System may be utilized when the medial or lateral condyle and the patellofemoral areas have been affected by one or more of the above noted conditions. The iDuo implant is intended 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 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, 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. This implant is intended for cemented use only. 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/K193105
Methodology: https://510kreport.com/methodology