510(k) · Cleared
ClearedStablyx CMC Arthroplasty Implant Model Sizes 1, 2, 3, 4, and 5
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 Dec 30, 2011 as substantially equivalent to K061451 (Ascension Orthopedics, Inc., 2006) and 1 other predicate after a 256-day review. Its family tree reaches back 4 generations to 1987. 1 later device descends from it.
- Decided
- Dec 30, 2011
- Review
- 256 days
- Class
- Class II
- Product code
- KYI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K864488 (1987). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK864488 Swanson Titanium Condylar ImplantDow Corning Wright · 1987
- 3 generations backK964472 Riopro Cobalt Trapeziometarcarpal Resurfacing ComponentBiologically Oriented Prostheses · 1997
- 2 generations backK041451 Ascension Pyrohemisphere, Models PHS-440-10, PHS-440-20, PHS-440-30…Ascension Orthopedics, Inc. · 2004 · Recalled
- 1 generation backK061451 Ascension, Models CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40Ascension Orthopedics, Inc. · 2006 · Recalled
- This deviceK111068 Stablyx CMC Arthroplasty Implant Model Sizes 1, 2, 3, 4, and 5Skeletal Dynamics, LLC · 2011
- Descendant · cites it directly · 0 of its ownK201072 Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161Ensemble Orthopedics, LLC · 2020
Most influential descendants
Showing 1 of 1 · See all- K201072Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161Ensemble Orthopedics, LLC · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K864488 | Swanson Titanium Condylar Implant | Dow Corning Wright | 1987 | — |
| −3 | K964472 | Riopro Cobalt Trapeziometarcarpal Resurfacing Component | Biologically Oriented Prostheses | 1997 | — |
| −2 | K041451 | Ascension Pyrohemisphere, Models PHS-440-10, PHS-440-20, PHS-440-30… | Ascension Orthopedics, Inc. | 2004 | 2 |
| −1 | K061451 | Ascension, Models CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40 | Ascension Orthopedics, Inc. | 2006 | 1 |
| 0 (this device) | K111068 | Stablyx CMC Arthroplasty Implant Model Sizes 1, 2, 3, 4, and 5 | Skeletal Dynamics, LLC | 2011 | — |
| +1 | K201072 | Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161 | Ensemble Orthopedics, LLC | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
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 1.9 · 6 generations · no Class I recall
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K061451 | Ascension, Models CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40Summary page 1…s, wrist, carpal trapezium Classification 21 CFR §888.3770 Product Code KYI Class Class 11 Predicate Devices: Ascension, PyroCarbon Saddle CMC (K061451) BioPro Modular Thumb Implant (K052596) Description of the Device: The Stablyx CMC Arthroplasty System is a hemi monoblock prost… | 2006 |
| * | K052596 | Modular Thumb Implant, Models…Summary page 1…on 21 CFR §888.3770 Product Code KYI Class Class 11 Predicate Devices: Ascension, PyroCarbon Saddle CMC (K061451) BioPro Modular Thumb Implant (K052596) Description of the Device: The Stablyx CMC Arthroplasty System is a hemi monoblock prosthesis for replacement of the first meta… | 2005 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K201072 | Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161 | 2020 | 0 |
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.
What does this lineage say?
- The line of descent spans 24 years and passes through 4 companies; a new generation was cleared every 7.6 years on median.
- 2 of the 6 ancestors have a recall of any class.
- Of its descendants, K201072 (Ensemble Orthopedics, LLC, 2020) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K061451.
How does its category compare?
All KYI devicesKYI Prosthesis, Wrist, Carpal Trapezium: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 Skeletal Dynamics Stablyx 0MGI Arthroplasty Implant Set 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 a painful, unstable thumb or a thumb with limited range of motion. This implant is intended for uncemented, press fit use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111068 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111068: Stablyx CMC Arthroplasty Implant Model Sizes 1, 2, 3, 4, and 5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111068
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026