# K092441: Modification to: Conformis Iuni Unicondylar Knee Repair System

- Pathway: 510(k) (Special)
- Applicant: Conformis, Inc.
- Decided: Sep 9, 2009 after 30 days
- Product code: HSX (Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3520
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K911802 (1992). 29 ancestors in all.
29 later devices descend from it; 2 cite it directly.
0 of 59 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043570: Unicondylar Knee Repair System / Conformis Ucd, Conformis, Inc. (2005) Summary page 2.
- K063432: Conformis Metal Backed Tibial Component (MBT), Conformis, Inc. (2007) Summary page 2.
- K072368: Conformis Metal Backed Tibial Component, Conformis, Inc. (2007) Summary page 2.
- K072586: Conformis Uni-Condylar Knee System, Conformis, Inc. (2007) Summary page 2.

## Most influential descendants
- K111916: Conformis Iuni Unicondylar Knee Replacement System (2011), 28 descendants of its own
- K121974: Conformis Iuni Unicondylar Knee Replacement System (2012), 27 descendants of its own
- K132640: Iuni Unicondylar Knee Replacement System (2013), 25 descendants of its own
- 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

## Indications for use
The ConforMIS Unicondylar Knee Repair System (iUni KRS) with curved tibial insert 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 repair 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 and * valgus or varus deformity of the knee. This implant is intended for cemented use only.

Source page: https://510kreport.com/device/K092441
Methodology: https://510kreport.com/methodology