510(k) · Cleared
Recalled · Class III · 2013Ascension, Models CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ascension Orthopedics, Inc. · KYI Prosthesis, Wrist, Carpal Trapezium
Cleared on Aug 11, 2006 as substantially equivalent to K041451 (Ascension Orthopedics, Inc., 2004) after a 78-day review. Its family tree reaches back 3 generations to 1987. 5 later devices descend from it. It has been recalled once.
- Decided
- Aug 11, 2006
- Review
- 78 days
- Class
- Class II
- Product code
- KYI
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K864488 (1987). 4 ancestors in all. 5 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK864488 Swanson Titanium Condylar ImplantDow Corning Wright · 1987
- 2 generations backK964472 Riopro Cobalt Trapeziometarcarpal Resurfacing ComponentBiologically Oriented Prostheses · 1997
- 1 generation backK041451 Ascension Pyrohemisphere, Models PHS-440-10, PHS-440-20, PHS-440-30…Ascension Orthopedics, Inc. · 2004 · Recalled
- This deviceK061451 Ascension, Models CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40Ascension Orthopedics, Inc. · 2006
- Descendant · cites it directly · 2 of its ownK080997 Ascension Pyrocarbon LunateAscension Orthopedics, Inc. · 2008
- Descendant · cites it directly · 1 of its ownK111068 Stablyx CMC Arthroplasty Implant Model Sizes 1, 2, 3, 4, and 5Skeletal Dynamics, LLC · 2011
- Descendant · 2 generations on · 1 of its ownK092548 Extremity Medical Trapezium ProsthesisExtremity Medical, LLC · 2009
- Descendant · cites it directly · 0 of its ownK201072 Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161Ensemble Orthopedics, LLC · 2020
- Descendant · cites it directly · 0 of its ownK112278 Ascension Nugrip CMC ImplantAscension Orthopedic · 2011
Most influential descendants
Showing 5 of 5 · See all- K080997Ascension Pyrocarbon LunateAscension Orthopedics, Inc. · 2008 · cites it directly2descendants
- K111068Stablyx CMC Arthroplasty Implant Model Sizes 1, 2, 3, 4, and 5Skeletal Dynamics, LLC · 2011 · cites it directly1descendant
- K092548Extremity Medical Trapezium ProsthesisExtremity Medical, LLC · 2009 · 2 generations on1descendant
- K201072Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161Ensemble Orthopedics, LLC · 2020 · cites it directly0descendants
- K112278Ascension Nugrip CMC ImplantAscension Orthopedic · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K864488 | Swanson Titanium Condylar Implant | Dow Corning Wright | 1987 | — |
| −2 | K964472 | Riopro Cobalt Trapeziometarcarpal Resurfacing Component | Biologically Oriented Prostheses | 1997 | — |
| −1 | K041451 | Ascension Pyrohemisphere, Models PHS-440-10, PHS-440-20, PHS-440-30… | Ascension Orthopedics, Inc. | 2004 | 2 |
| 0 (this device) | K061451 | Ascension, Models CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40 | Ascension Orthopedics, Inc. | 2006 | — |
| +1 | K080997 | Ascension Pyrocarbon Lunate | Ascension Orthopedics, Inc. | 2008 | — |
| +1 | K111068 | Stablyx CMC Arthroplasty Implant Model Sizes 1, 2, 3, 4, and 5 | Skeletal Dynamics, LLC | 2011 | — |
| +2 | K092548 | Extremity Medical Trapezium Prosthesis | Extremity Medical, LLC | 2009 | — |
| +1 | K201072 | Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161 | Ensemble Orthopedics, LLC | 2020 | — |
| +1 | K112278 | Ascension Nugrip CMC Implant | Ascension Orthopedic | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K041451 | Ascension Pyrohemisphere, Models PHS-440-10, PHS-440-20, PHS-440-30, PHS-440-40…Summary page 1…prosthesis PRODUCT CODE: KYI PANEL: Orthopedic Devices PREDICATE DEVICE: Ascension® PHS, (K041451) DEVICE DESCRIPTION: The Ascensiono CMC is intended for use as a hemi joint replacement for the base of the first metacarpal of… | 2004 |
What descends from it? (5)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 3, 2013 | Class III | Z-1568-2013 | Labeling Change Control | As a result of a quality review, labelling content discrepancies were identified between the Instruction for Use (IFU) distributed in the US with the Ascension CMC and the content that is cleared by FDA. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 7.6 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K080997 (Ascension Orthopedics, Inc., 2008) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K041451.
How does its category compare?
All KYI devicesKYI Prosthesis, Wrist, Carpal Trapezium: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Ascension CMC 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 is an uncemented prosthesis designed for press fit use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061451 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061451: Ascension, Models CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061451
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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