# K132640: Iuni Unicondylar Knee Replacement System

- Pathway: 510(k) (Traditional)
- Applicant: Conformis, Inc.
- Decided: Dec 5, 2013 after 104 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: 9 generations back to K911802 (1992). 34 ancestors in all.
25 later devices descend from it; 2 cite it directly.
0 of 60 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121974: Conformis Iuni Unicondylar Knee Replacement System, Conformis, Inc. (2012) Summary page 1.
- K111916: Conformis Iuni Unicondylar Knee Replacement System, Conformis, Inc. (2011) Summary page 1.

## Most influential descendants
- K193105: iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee Repair System, iTotal CR Knee Replacement System, iTotal PS Knee Replacement System (2020), 15 descendants of its own
- K201023: iTotal® Identity Posterior Stabilized Knee Replacement System (2020), 14 descendants of its own
- K203447: iTotal Identity Cruciate Retaining (CR) Total Knee Replacement, iTotal Identity Posterior Stabilizing (PS) Total Knee Replacement (2020), 12 descendants of its own
- K210191: Identity Imprint Knee Replacement System (2021), 10 descendants of its own
- K212411: Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS) (2021), 9 descendants of its own

## Recalls of this device
- Aug 31, 2015 · Class II · Z-0138-2016: May contain small amounts of ethylene glycol residue
- Aug 31, 2015 · Class II · Z-0139-2016: May contain small amounts of ethylene glycol residue
- Aug 31, 2015 · Class II · Z-0140-2016: May contain small amounts of ethylene glycol residue

## Indications for use
The ConforMiS Unicondylar Knee Replacement System (iUni) is intended for use in one compartment of the osteoarthritic knee to replace the damaged area of the articular surface in patients with evidence of adequate healthy bone sufficient for support of the implanted components. Candidates for unicondylar knee replacement include those with: * joint impairment due to osteoarthritis or traumatic arthritis of the knee * previous femoral condyle or tibial plateau fracture, creating loss of function * valgus or varus deformity of the knee * revision procedures provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans This implant is intended for cemented use only.

Source page: https://510kreport.com/device/K132640
Methodology: https://510kreport.com/methodology