510(k) · Cleared
ClearedEnsemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ensemble Orthopedics, LLC · KYI Prosthesis, Wrist, Carpal Trapezium
Cleared on Dec 2, 2020 as substantially equivalent to K042690 (Ascension Orthopedics, Inc., 2004) and 4 other predicates after a 224-day review. Its family tree reaches back 6 generations to 1987.
- Decided
- Dec 2, 2020
- Review
- 224 days
- Class
- Class II
- Product code
- KYI
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 6 generations to K864488 (1987). 16 ancestors in all, the oldest K781756 (1978). No later device cites it as a predicate yet.
- Root · 6 generations backK864488 Swanson Titanium Condylar ImplantDow Corning Wright · 1987
- 5 generations backK964472 Riopro Cobalt Trapeziometarcarpal Resurfacing ComponentBiologically Oriented Prostheses · 1997
- 4 generations backK041451 Ascension Pyrohemisphere, Models PHS-440-10, PHS-440-20, PHS-440-30…Ascension Orthopedics, Inc. · 2004 · Recalled
- 3 generations backK061451 Ascension, Models CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40Ascension Orthopedics, Inc. · 2006 · Recalled
- 2 generations backK080997 Ascension Pyrocarbon LunateAscension Orthopedics, Inc. · 2008
- 1 generation backK092548 Extremity Medical Trapezium ProsthesisExtremity Medical, LLC · 2009
- This deviceK201072 Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161Ensemble Orthopedics, LLC · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K864488 | Swanson Titanium Condylar Implant | Dow Corning Wright | 1987 | — |
| −5 | K964472 | Riopro Cobalt Trapeziometarcarpal Resurfacing Component | Biologically Oriented Prostheses | 1997 | — |
| −4 | K041451 | Ascension Pyrohemisphere, Models PHS-440-10, PHS-440-20, PHS-440-30… | Ascension Orthopedics, Inc. | 2004 | 2 |
| −3 | K061451 | Ascension, Models CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40 | Ascension Orthopedics, Inc. | 2006 | 1 |
| −2 | K080997 | Ascension Pyrocarbon Lunate | Ascension Orthopedics, Inc. | 2008 | — |
| −1 | K092548 | Extremity Medical Trapezium Prosthesis | Extremity Medical, LLC | 2009 | — |
| 0 (this device) | 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 |
|---|---|---|
| 1978 | 1 | 0 |
| 1987 | 2 | 0 |
| 1997 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2011 | 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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K042690 | Ascension Pyrosphere (PCS)Summary page 4…Name: Wrist joint carpal trapezium polymer prosthesis Classification: 21 CFR 888.3770 Product Code: KYI Regulatory Class: Class II Predicate Devices: K042690 Ascension PyroSphere, Cleared December 13, 2004 K061451 Ascension CMC, Cleared August 11, 2006 K092548 Extremity Medi… | 2004 |
| * | K061451 | Ascension, Models CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40Summary page 4…assification: 21 CFR 888.3770 Product Code: KYI Regulatory Class: Class II Predicate Devices: K042690 Ascension PyroSphere, Cleared December 13, 2004 K061451 Ascension CMC, Cleared August 11, 2006 K092548 Extremity Medical Trapezium, December 15, 2009 K111068 Stablyx CMC Art… | 2006 |
| * | K092548 | Extremity Medical Trapezium ProsthesisSummary page 4…KYI Regulatory Class: Class II Predicate Devices: K042690 Ascension PyroSphere, Cleared December 13, 2004 K061451 Ascension CMC, Cleared August 11, 2006 K092548 Extremity Medical Trapezium, December 15, 2009 K111068 Stablyx CMC Arthroplasty, Cleared December 30, 2011 K033529 Ti… | 2009 |
| * | K111068 | Stablyx CMC Arthroplasty Implant Model Sizes 1, 2, 3, 4, and 5Summary page 4…K042690 Ascension PyroSphere, Cleared December 13, 2004 K061451 Ascension CMC, Cleared August 11, 2006 K092548 Extremity Medical Trapezium, December 15, 2009 K111068 Stablyx CMC Arthroplasty, Cleared December 30, 2011 K033529 Tie-In Trapezium, Cleared December 3, 2003 Description of th… | 2011 |
| * | K033529 | Tie-in TrapeziumSummary page 4…451 Ascension CMC, Cleared August 11, 2006 K092548 Extremity Medical Trapezium, December 15, 2009 K111068 Stablyx CMC Arthroplasty, Cleared December 30, 2011 K033529 Tie-In Trapezium, Cleared December 3, 2003 Description of the Device: The Ensemble CMC implant is a single use, uncemented,… | 2003 |
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.
What does this lineage say?
- The line of descent spans 33 years and passes through 5 companies; a new generation was cleared every 7.6 years on median.
- 2 of the 16 ancestors have a recall of any class.
- 2 other devices also cite its predicate K042690.
How does its category compare?
All KYI devicesKYI Prosthesis, Wrist, Carpal Trapezium: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 Ensemble CMC is intended to replace the joint between the first metacarpal and the trapezium in cases of rheumatoid arthritis, traumatic arthritis, osteoarthritis, or post fracture deformation of bone loss which present as either a painful, unstable thumb, or a thumb with limited range of motion.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K201072 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201072: Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201072
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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