# K093513: Iduo Bicompartmental Knee Repair System

- Pathway: 510(k) (Special)
- Applicant: Conformis, Inc.
- Decided: Dec 16, 2009 after 33 days
- Product code: NPJ (Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3560
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K911802 (1992). 18 ancestors in all.
17 later devices descend from it; 2 cite it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053488: Conformis Bicompartmental Knee Repair System, Conformis, Inc. (2006) Summary page 3.

## Most influential descendants
- K133256: Itotal Cruciate Retaining, Iuni Unicondylar Knee Replacement Systems, Iduo Bicompartmental Knee Repair System (2014), 16 descendants of its own
- K193105: iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee Repair System, iTotal CR Knee Replacement System, iTotal PS Knee Replacement System (2020), 15 descendants of its own
- 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

## Recalls of this device
- Aug 31, 2015 · Class II · Z-0142-2016: May contain small amounts of ethylene glycol residue
- Aug 31, 2015 · Class II · Z-0148-2016: May contain small amounts of ethylene glycol residue
- Aug 31, 2015 · Class II · Z-0143-2016: May contain small amounts of ethylene glycol residue

## Indications for use
The ConforMlS iDuo Bicompartmental Knee Repair System (iDuo KRS) 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 including restoring joint function and relief of pain due to: - painful joint disease due to osteoarthritis, traumatic arthritis or rheumatoid arthritis of the knee, - post traumatic loss of joint function - failed osteotomies, hemiarthroplasties, and unicondylar implants. The iDuo KRS may be utilized when the medial or lateral condyle and the patellofemoral areas have been affected by one or more of these conditions. The iDuo KRS is intended for cemented use only.

Source page: https://510kreport.com/device/K093513
Methodology: https://510kreport.com/methodology