# K063432: Conformis Metal Backed Tibial Component (MBT)

- Pathway: 510(k) (Traditional)
- Applicant: Conformis, Inc.
- Decided: Mar 16, 2007 after 123 days
- Product code: HSX (Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3520
- 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). 22 ancestors in all.
32 later devices descend from it; 4 cite it directly.
0 of 55 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.
- K053488: Conformis Bicompartmental Knee Repair System, Conformis, Inc. (2006) Summary page 2.
- K040268: Depuy Preservation Unicondylar Tibia, DePuy Orthopaedics, Inc. (2004) Summary page 2.
- K954186: Sled Unicompartment Knee System, Link America, Inc. (1996) Summary page 2.

## Most influential descendants
- K072368: Conformis Metal Backed Tibial Component (2007), 31 descendants of its own
- 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

## Recalls of this device
- Apr 23, 2009 · Not classified · Z-1623-2009: Microscopic cracks potential for pre-mature revisions in patients implanted with the system.
- Apr 23, 2009 · Not classified · Z-1624-2009: Microscopic cracks potential for pre-mature revisions in patients implanted with the system.
- Apr 23, 2009 · Not classified · Z-1622-2009: Microscopic cracks potential for pre-mature revisions in patients implanted with the system.

## Indications for use
The ConforMIS metal backed tibial component is intended for use with the ConforMIS Unicondylar Knee Repair System and the ConforMIS BiCompartmental Knee Repair Systems, 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 metal backed tibial component is intended only for use with bone cement

Source page: https://510kreport.com/device/K063432
Methodology: https://510kreport.com/methodology