# K052687: Conformis, Inc. Total Knee Repair System

- Pathway: 510(k) (Traditional)
- Applicant: Conformis, Inc.
- Decided: Aug 31, 2006 after 337 days
- Product code: JWH (Prosthesis, Knee, Patellofemorotibial, 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). 19 ancestors in all.
43 later devices descend from it; 2 cite it directly.
0 of 63 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.
- K043570: Unicondylar Knee Repair System / Conformis Ucd, Conformis, Inc. (2005) Summary page 2.
- K000978: Anatomic Total Knee Prosthesis, Biomet, Inc. (2000) Summary page 2.
- K974328: Advance Total Knee System, Wrightmedicaltechnologyinc (1998) Summary page 2.
- K021740: Total Knee Cemented, Semi-Constrained, Dj Orthopedics, LLC (2002) Summary page 2.

## Most influential descendants
- K094050: Itotal CR Knee Replacement System (2010), 41 descendants of its own
- K103117: Itotal Cruciate Retaining (CR) Knee Replacement System (2011), 40 descendants of its own
- K112780: Conformis Itotal Cruciate Retaining (CR) Knee Replacement System (2011), 38 descendants of its own
- K120316: Itotal Cruciate Retaining (CR) Knee Replacement System (2012), 36 descendants of its own
- K113378: Conformis Itotal Cruciate Retaining (CR) Knee Replacement System (2012), 36 descendants of its own

## Indications for use
The ConforMIS Tri-compartmental Resurfacing Device (tCR)is a minimally invasive, bone preserving primary total knee system intended 'for use in patients with severe knee joint pain and disability. The indications for use include restoring joint function and relief of pain due to: * Painful joint disease due to osteoarthritis, traumatic arthritis, rheumatoid arthritis of the knee • Post traumatic loss of joint function * Mild to moderate valgus or varus deformity of the knee The ConforMIS Tri-compartmental Resurfacing (tCR) Device is intended only for use with bone cement.

Source page: https://510kreport.com/device/K052687
Methodology: https://510kreport.com/methodology