510(k) · Cleared
Recalled · Class II · 2023Sled Unicompartment Knee System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Link America, Inc. · HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
Cleared on Jan 26, 1996 after a 142-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 55 later devices descend from it. It has been recalled 32 times.
- Decided
- Jan 26, 1996
- Review
- 142 days
- Class
- Class II
- Product code
- HSX
- Recalls
- 32
- Predicates
- 0
55 later devices descend from it, 6 citing it directly.
- This deviceK954186 Sled Unicompartment Knee SystemLink America, Inc. · 1996
- Descendant · cites it directly · 32 of its ownK063432 Conformis Metal Backed Tibial Component (MBT)Conformis, Inc. · 2007 · Recalled
- Descendant · 2 generations on · 31 of its ownK072368 Conformis Metal Backed Tibial ComponentConformis, Inc. · 2007 · Recalled
- Descendant · 2 generations on · 29 of its ownK092441 Modification to: Conformis Iuni Unicondylar Knee Repair SystemConformis, Inc. · 2009
- Descendant · 2 generations on · 28 of its ownK111916 Conformis Iuni Unicondylar Knee Replacement SystemConformis, Inc. · 2011
- Descendant · 2 generations on · 27 of its ownK121974 Conformis Iuni Unicondylar Knee Replacement SystemConformis, Inc. · 2012
Showing 5 of 55 descendants. See all descendants
Descendants cleared per year
2003high 15 (2021) · low 0 (2006)2026
Most influential descendants
Showing 5 of 55 · See all- K063432Conformis Metal Backed Tibial Component (MBT)Conformis, Inc. · 2007 · cites it directly32descendants
- K072368Conformis Metal Backed Tibial ComponentConformis, Inc. · 2007 · 2 generations on31descendants
- K092441Modification to: Conformis Iuni Unicondylar Knee Repair SystemConformis, Inc. · 2009 · 2 generations on29descendants
- K111916Conformis Iuni Unicondylar Knee Replacement SystemConformis, Inc. · 2011 · 2 generations on28descendants
- K121974Conformis Iuni Unicondylar Knee Replacement SystemConformis, Inc. · 2012 · 2 generations on27descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K954186 | Sled Unicompartment Knee System | Link America, Inc. | 1996 | — |
| +1 | K063432 | Conformis Metal Backed Tibial Component (MBT) | Conformis, Inc. | 2007 | 3 |
| +2 | K072368 | Conformis Metal Backed Tibial Component | Conformis, Inc. | 2007 | 3 |
| +2 | K092441 | Modification to: Conformis Iuni Unicondylar Knee Repair System | Conformis, Inc. | 2009 | — |
| +2 | K111916 | Conformis Iuni Unicondylar Knee Replacement System | Conformis, Inc. | 2011 | — |
| +2 | K121974 | Conformis Iuni Unicondylar Knee Replacement System | Conformis, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2019 | 3 | 0 |
| 2020 | 4 | 0 |
| 2021 | 15 | 0 |
| 2022 | 3 | 0 |
| 2023 | 7 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HSX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HSX device
- #1 K261609 Freedom Partial Knee Systemscore 15.1 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (55)
See all 556 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K063432 | Conformis Metal Backed Tibial Component (MBT) | 2007 | 32 |
| K152431 | LINK Endo-Model Knee System with PorEx (TiNbN) coating, Link Sled Knee System with PorEx… | 2016 | 9 |
| K042093 | Vanguard M Series Unicondylar Tibial Bearings | 2004 | 6 |
| K050373 | Unicap Unicompartmental Knee Resurfacing Prosthesis | 2005 | 2 |
| K050764 | Uniglide Unicondylar Knee Prosthesis | 2005 | 2 |
| K022211 | HLS Uni Evolution Prosthesis | 2003 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 21, 2023 | Class II | Z-1517-2023 | Labeling design | 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 caused by suboptimal positioning of the… |
| Mar 21, 2023 | Class II | Z-1529-2023 | Labeling design | 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 caused by suboptimal positioning of the… |
| Mar 21, 2023 | Class II | Z-1531-2023 | Labeling design | 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 caused by suboptimal positioning of the… |
| Mar 21, 2023 | Class II | Z-1522-2023 | Labeling design | 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 caused by suboptimal positioning of the… |
| Mar 21, 2023 | Class II | Z-1512-2023 | Labeling design | 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 caused by suboptimal positioning of the… |
| Mar 21, 2023 | Class II | Z-1534-2023 | Labeling design | 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 caused by suboptimal positioning of the… |
| Mar 21, 2023 | Class II | Z-1508-2023 | Labeling design | 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 caused by suboptimal positioning of the… |
| Mar 21, 2023 | Class II | Z-1536-2023 | Labeling design | 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 caused by suboptimal positioning of the… |
| Mar 21, 2023 | Class II | Z-1538-2023 | Labeling design | 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 caused by suboptimal positioning of the… |
| Mar 21, 2023 | Class II | Z-1524-2023 | Labeling design | 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 caused by suboptimal positioning of the… |
| Mar 21, 2023 | Class II | Z-1510-2023 | Labeling design | 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 caused by suboptimal positioning of the… |
| Mar 21, 2023 | Class II | Z-1530-2023 | Labeling design | 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 caused by suboptimal positioning of the… |
| Mar 21, 2023 | Class II | Z-1525-2023 | Labeling design | 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 caused by suboptimal positioning of the… |
| Mar 21, 2023 | Class II | Z-1513-2023 | Labeling design | 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 caused by suboptimal positioning of the… |
| Mar 21, 2023 | Class II | Z-1520-2023 | Labeling design | 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 caused by suboptimal positioning of the… |
| Mar 21, 2023 | Class II | Z-1509-2023 | Labeling design | 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 caused by suboptimal positioning of the… |
| Mar 21, 2023 | Class II | Z-1507-2023 | Labeling design | 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 caused by suboptimal positioning of the… |
| Mar 21, 2023 | Class II | Z-1526-2023 | Labeling design | 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 caused by suboptimal positioning of the… |
| Mar 21, 2023 | Class II | Z-1515-2023 | Labeling design | 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 caused by suboptimal positioning of the… |
| Mar 21, 2023 | Class II | Z-1528-2023 | Labeling design | 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 caused by suboptimal positioning of the… |
| Mar 21, 2023 | Class II | Z-1527-2023 | Labeling design | 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 caused by suboptimal positioning of the… |
| Mar 21, 2023 | Class II | Z-1511-2023 | Labeling design | 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 caused by suboptimal positioning of the… |
| Mar 21, 2023 | Class II | Z-1537-2023 | Labeling design | 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 caused by suboptimal positioning of the… |
| Mar 21, 2023 | Class II | Z-1514-2023 | Labeling design | 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 caused by suboptimal positioning of the… |
| Mar 21, 2023 | Class II | Z-1532-2023 | Labeling design | 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 caused by suboptimal positioning of the… |
| Mar 21, 2023 | Class II | Z-1516-2023 | Labeling design | 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 caused by suboptimal positioning of the… |
| Mar 21, 2023 | Class II | Z-1521-2023 | Labeling design | 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 caused by suboptimal positioning of the… |
| Mar 21, 2023 | Class II | Z-1519-2023 | Labeling design | 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 caused by suboptimal positioning of the… |
| Mar 21, 2023 | Class II | Z-1523-2023 | Labeling design | 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 caused by suboptimal positioning of the… |
| Mar 21, 2023 | Class II | Z-1533-2023 | Labeling design | 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 caused by suboptimal positioning of the… |
| Mar 21, 2023 | Class II | Z-1518-2023 | Labeling design | 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 caused by suboptimal positioning of the… |
| Mar 21, 2023 | Class II | Z-1535-2023 | Labeling design | 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 caused by suboptimal positioning of the… |
The 5 latest of 32 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K063432 (Conformis, Inc., 2007) has gone furthest, with 32 descendants of its own.
How does its category compare?
All HSX devicesHSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HSX
4in 2025
2007high 7 (2019) · low 0 (2014)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · HSX
59in 2025
2007high 160 (2017) · low 33 (2007)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HSX
2in 2020
2007high 49 (2009) · low 0 (2007)2026
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HSX
175in 2025
2007high 273 (2020) · low 4 (2008)2025
MAUDE reports naming product code HSX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 6 | 33 | 0 | 6 |
| 2008 | 4 | 102 | 0 | 4 |
| 2009 | 2 | — | 49 | 21 |
| 2010 | 3 | 74 | 0 | 58 |
| 2011 | 1 | — | 0 | 114 |
| 2012 | 5 | 88 | 0 | 83 |
| 2013 | 2 | — | 1 | 79 |
| 2014 | 0 | — | 0 | 66 |
| 2015 | 1 | — | 0 | 57 |
| 2016 | 3 | 147 | 1 | 107 |
| 2017 | 5 | 160 | 4 | 113 |
| 2018 | 2 | — | 0 | 159 |
| 2019 | 7 | 90 | 0 | 177 |
| 2020 | 4 | 40 | 2 | 273 |
| 2021 | 7 | 81 | 0 | 240 |
| 2022 | 2 | — | 0 | 257 |
| 2023 | 1 | — | 0 | 231 |
| 2024 | 4 | 133 | 0 | 172 |
| 2025 | 4 | 59 | 0 | 175 |
| 2026 | 2 | — | 0 | — |
https://510kreport.com/device/K954186 · printed Nov 4, 2026
Cite this page
510(k) Report. “K954186: Sled Unicompartment Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K954186
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026