# K043570: Unicondylar Knee Repair System / Conformis Ucd

- Pathway: 510(k) (Traditional)
- Applicant: Conformis, Inc.
- Decided: Mar 14, 2005 after 77 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: 2 generations back to K911802 (1992). 14 ancestors in all.
62 later devices descend from it; 9 cite it directly.
0 of 77 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.
- K033363: Zimmer Unicompartmental Knee System, Zimmer, Inc. (2004) Summary page 2.
- K033769: Eius Unicompartmental Knee System, Howmedica Osteonics Corp. (2004) Summary page 2.
- (no number) Repicci II Unicondylar Knee: named in the summary without a submission number

## Most influential descendants
- K052687: Conformis, Inc. Total Knee Repair System (2006), 43 descendants of its own
- 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

## 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™ 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/K043570
Methodology: https://510kreport.com/methodology