# K053488: Conformis Bicompartmental Knee Repair System

- Pathway: 510(k) (Traditional)
- Applicant: Conformis, Inc.
- Decided: Mar 9, 2006 after 84 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K911802 (1992). 17 ancestors in all.
35 later devices descend from it; 5 cite it directly.
0 of 53 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033242: Knee Interpositional Mini-Repair System (Kimrs), Imaging Therapeutics, Inc. (2003) Summary page 2.
- K042896: Smith & Nephew Hybrid Knee Femoral, Smith & Nephew, Inc. (2005) Summary page 2.
- K043570: Unicondylar Knee Repair System / Conformis Ucd, Conformis, Inc. (2005) Summary page 2.
- K002356: Natural-Knee II Patellofemoral Joint Prosthesis, Sulzer Orthopedics, Inc. (2000) Summary page 2.

## Most influential descendants
- K063432: Conformis Metal Backed Tibial Component (MBT) (2007), 32 descendants of its own
- K072368: Conformis Metal Backed Tibial Component (2007), 31 descendants of its own
- K072586: Conformis Uni-Condylar Knee System (2007), 30 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

## Indications for use
The ConforMIS, Inc., 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 or rheumatoid arthritis of the knee * post traumatic loss of joint function * failed osteotomies, hemiarthoplasties and unicondylar implants. The 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 these conditions. The ConforMIS, Inc., BiCompartmental Knee Repair System is intended only for use with bone cement.

Source page: https://510kreport.com/device/K053488
Methodology: https://510kreport.com/methodology