# K072586: Conformis Uni-Condylar Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Conformis, Inc.
- Decided: Nov 8, 2007 after 56 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: 4 generations back to K911802 (1992). 18 ancestors in all.
30 later devices descend from it; 3 cite it directly.
0 of 49 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 1.
- K053488: Conformis Bicompartmental Knee Repair System, Conformis, Inc. (2006) Summary page 1.

## Cited in the summary but kept off the family tree
- K052876: Telithromycin 15UG BBL Sensi-Disc, Becton, Dickinson & CO (2005). Our reading of the summary gave K052876, FDA’s number for Telithromycin 15UG BBL Sensi-Disc (Becton, Dickinson & CO). Its FDA name has none of the distinctive words the summary uses for the device it names, “ConforMIS Total Knee”. Kept off the family tree.

## Most influential descendants
- K092441: Modification to: Conformis Iuni Unicondylar Knee Repair System (2009), 29 descendants of its own
- 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

## Indications for use
The ConforMIS unicondylar implant is intended for use in patients with: * joint impairment due to osteoarthritis or traumatic arthritis of the knee * previous tibial condyle or plateau fracture, creating loss of function * valgus or varus deformity of the knee The ConforMIS unicondylar implant is for use with bone cement

Source page: https://510kreport.com/device/K072586
Methodology: https://510kreport.com/methodology