# K131167: Univation

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap Implant Systems, LLC
- Decided: Oct 17, 2013 after 176 days
- Product code: HRY (Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3530
- Recalls of this device: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K915192 (1992). 26 ancestors in all.
No later device cites it as a predicate yet.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081293: Univation Unicondylar Knee System, Aesculap Implant Systems, Inc. (2008) Summary page 1.

## Recalls of this device
- Mar 19, 2021 · Class II · Z-2510-2021: Malfunction- loosening of the implant resulting in a potential revision surgery
- Mar 19, 2021 · Class II · Z-2512-2021: Malfunction- loosening of the implant resulting in a potential revision surgery
- Mar 19, 2021 · Class II · Z-2514-2021: Malfunction- loosening of the implant resulting in a potential revision surgery
- Mar 19, 2021 · Class II · Z-2516-2021: Malfunction- loosening of the implant resulting in a potential revision surgery
- Mar 19, 2021 · Class II · Z-2509-2021: Malfunction- loosening of the implant resulting in a potential revision surgery
- Mar 19, 2021 · Class II · Z-2511-2021: Malfunction- loosening of the implant resulting in a potential revision surgery
- Mar 19, 2021 · Class II · Z-2515-2021: Malfunction- loosening of the implant resulting in a potential revision surgery
- Mar 19, 2021 · Class II · Z-2513-2021: Malfunction- loosening of the implant resulting in a potential revision surgery

## Indications for use
The UNIVATION® Unicompartmental Knee System is indicated for cemented use only in patients undergoing surgery for a severely painful and/or disabled joint damaged as a result of osteoarthritis, traumatic arthritis, or a failed previous implant when only one condyle of the knee (medial) is affected.

Source page: https://510kreport.com/device/K131167
Methodology: https://510kreport.com/methodology