510(k) · Cleared
ClearedStablyx CMC Arthroplasty Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Skeletal Dynamics, LLC · KYI Prosthesis, Wrist, Carpal Trapezium
Cleared on Apr 11, 2018 after a 20-day review. The FDA summary names its predicate without a number.
- Decided
- Apr 11, 2018
- Review
- 20 days
- Class
- Class II
- Product code
- KYI
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KYI? 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 KYI device
- #1 K201072 Ensemble CMC, Size 141, Ensemble CMC, Size…score 2.0 · 6 generations · no Class I recall
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Stablyx CMC Arthroplasty Implant System Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All KYI devicesKYI Prosthesis, Wrist, Carpal Trapezium: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · KYI
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · KYI
Too few KYI 510(k)s in any year since 2007 to give a median.
Recalls per year · KYI
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KYI
1in 2024
MAUDE reports naming product code KYI, 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 | 2 | — | 0 | 32 |
| 2008 | 0 | — | 0 | 51 |
| 2009 | 1 | — | 0 | 56 |
| 2010 | 0 | — | 2 | 25 |
| 2011 | 2 | — | 0 | 72 |
| 2012 | 0 | — | 0 | 22 |
| 2013 | 0 | — | 0 | 23 |
| 2014 | 0 | — | 0 | 4 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 1 | 3 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 4 |
| 2019 | 0 | — | 0 | 14 |
| 2020 | 1 | — | 0 | 8 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Stablyx CMC Arthroplasty Implant System is intended to replace the proximal end of the first metacarpal in cases of rheumatoid arthritis, traumatic arthritis, osteoarthritis or post fracture deformation or bone loss which present as either painful, unstable thumb or a thumb with limited range of motion. The implant is intended for uncemented, press fit use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180744 · printed Nov 4, 2026
Cite this page
510(k) Report. “K180744: Stablyx CMC Arthroplasty Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K180744
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026