# K954186: Sled Unicompartment Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Link America, Inc.
- Decided: Jan 26, 1996 after 142 days
- Product code: HSX (Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3520
- Recalls of this device: 32 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
55 later devices descend from it; 6 cite it directly.
0 of 56 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## 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
- 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
- K121974: Conformis Iuni Unicondylar Knee Replacement System (2012), 27 descendants of its own

## Recalls of this device
- Mar 21, 2023 · Class II · Z-1517-2023: Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant cau
- Mar 21, 2023 · Class II · Z-1529-2023: Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant cau
- Mar 21, 2023 · Class II · Z-1531-2023: Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant cau
- Mar 21, 2023 · Class II · Z-1522-2023: Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant cau
- Mar 21, 2023 · Class II · Z-1512-2023: Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant cau
- Mar 21, 2023 · Class II · Z-1534-2023: Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant cau
- Mar 21, 2023 · Class II · Z-1508-2023: Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant cau
- Mar 21, 2023 · Class II · Z-1536-2023: Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant cau
- Mar 21, 2023 · Class II · Z-1538-2023: Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant cau
- Mar 21, 2023 · Class II · Z-1524-2023: Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant cau
- Mar 21, 2023 · Class II · Z-1510-2023: Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant cau
- Mar 21, 2023 · Class II · Z-1530-2023: Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant cau
- Mar 21, 2023 · Class II · Z-1525-2023: Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant cau
- Mar 21, 2023 · Class II · Z-1513-2023: Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant cau
- Mar 21, 2023 · Class II · Z-1520-2023: Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant cau
- Mar 21, 2023 · Class II · Z-1509-2023: Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant cau
- Mar 21, 2023 · Class II · Z-1507-2023: Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant cau
- Mar 21, 2023 · Class II · Z-1526-2023: Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant cau
- Mar 21, 2023 · Class II · Z-1515-2023: Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant cau
- Mar 21, 2023 · Class II · Z-1528-2023: Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant cau
- Mar 21, 2023 · Class II · Z-1527-2023: Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant cau
- Mar 21, 2023 · Class II · Z-1511-2023: Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant cau
- Mar 21, 2023 · Class II · Z-1537-2023: Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant cau
- Mar 21, 2023 · Class II · Z-1514-2023: Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant cau
- Mar 21, 2023 · Class II · Z-1532-2023: Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant cau
- Mar 21, 2023 · Class II · Z-1516-2023: Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant cau
- Mar 21, 2023 · Class II · Z-1521-2023: Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant cau
- Mar 21, 2023 · Class II · Z-1519-2023: Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant cau
- Mar 21, 2023 · Class II · Z-1523-2023: Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant cau
- Mar 21, 2023 · Class II · Z-1533-2023: Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant cau
- Mar 21, 2023 · Class II · Z-1518-2023: Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant cau
- Mar 21, 2023 · Class II · Z-1535-2023: Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant cau

Source page: https://510kreport.com/device/K954186
Methodology: https://510kreport.com/methodology