510(k) · Cleared
ClearedCeramic Spherical CMC Implant (Subject to Marketing Approval)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wrightmedicaltechnologyinc · KYI Prosthesis, Wrist, Carpal Trapezium
Cleared on Feb 6, 1997 after a 356-day review. The FDA summary names its predicate without a number. 10 later devices descend from it.
- Decided
- Feb 6, 1997
- Review
- 356 days
- Class
- Class II
- Product code
- KYI
- Recalls
- None
- Predicates
- 0
10 later devices descend from it, 3 citing it directly.
- This deviceK960659 Ceramic Spherical CMC Implant (Subject to Marketing Approval)Wrightmedicaltechnologyinc · 1997
- Descendant · cites it directly · 8 of its ownK041451 Ascension Pyrohemisphere, Models PHS-440-10, PHS-440-20, PHS-440-30…Ascension Orthopedics, Inc. · 2004 · Recalled
- Descendant · 2 generations on · 5 of its ownK061451 Ascension, Models CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40Ascension Orthopedics, Inc. · 2006 · Recalled
- Descendant · cites it directly · 3 of its ownK042690 Ascension Pyrosphere (PCS)Ascension Orthopedics, Inc. · 2004
- Descendant · 3 generations on · 2 of its ownK080997 Ascension Pyrocarbon LunateAscension Orthopedics, Inc. · 2008
- Descendant · 3 generations on · 1 of its ownK111068 Stablyx CMC Arthroplasty Implant Model Sizes 1, 2, 3, 4, and 5Skeletal Dynamics, LLC · 2011
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K041451Ascension Pyrohemisphere, Models PHS-440-10, PHS-440-20, PHS-440-30, PHS-440-40…Ascension Orthopedics, Inc. · 2004 · cites it directly8descendants
- K061451Ascension, Models CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40Ascension Orthopedics, Inc. · 2006 · 2 generations on5descendants
- K042690Ascension Pyrosphere (PCS)Ascension Orthopedics, Inc. · 2004 · cites it directly3descendants
- K080997Ascension Pyrocarbon LunateAscension Orthopedics, Inc. · 2008 · 3 generations on2descendants
- K111068Stablyx CMC Arthroplasty Implant Model Sizes 1, 2, 3, 4, and 5Skeletal Dynamics, LLC · 2011 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K960659 | Ceramic Spherical CMC Implant (Subject to Marketing Approval) | Wrightmedicaltechnologyinc | 1997 | — |
| +1 | K041451 | Ascension Pyrohemisphere, Models PHS-440-10, PHS-440-20, PHS-440-30… | Ascension Orthopedics, Inc. | 2004 | 2 |
| +2 | K061451 | Ascension, Models CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40 | Ascension Orthopedics, Inc. | 2006 | 1 |
| +1 | K042690 | Ascension Pyrosphere (PCS) | Ascension Orthopedics, Inc. | 2004 | — |
| +3 | K080997 | Ascension Pyrocarbon Lunate | Ascension Orthopedics, Inc. | 2008 | — |
| +3 | K111068 | Stablyx CMC Arthroplasty Implant Model Sizes 1, 2, 3, 4, and 5 | Skeletal Dynamics, LLC | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2006 | 2 | 0 |
| 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 |
|---|---|---|---|
| * | — | Swanson Titanium Condylar Implant Named without a submission number |
What descends from it? (10)
3 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K041451 (Ascension Orthopedics, Inc., 2004) has gone furthest, with 8 descendants of its own.
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 Ceramic Spherical CMC Implant is intended to be used as an adjunct to resection arthroplasty of the carpometacarpal (CMC) joint in cases of degenerative arthritis or post-traumatic arthritis limited to that joint. It acts as a spacer to preserve joint relationship and allow appropriate capsuloligamentous reconstruction to correct deformities. The implant will rest in a spherical cavity created by two hemispherical shapes in the trapezium and the…
Read the full statement (144 words)
The Ceramic Spherical CMC Implant is intended to be used as an adjunct to resection arthroplasty of the carpometacarpal (CMC) joint in cases of degenerative arthritis or post-traumatic arthritis limited to that joint. It acts as a spacer to preserve joint relationship and allow appropriate capsuloligamentous reconstruction to correct deformities. The implant will rest in a spherical cavity created by two hemispherical shapes in the trapezium and the first metacarpal. The implant will articulate directly on bone.
Use of the CMC Implant may be considered in cases of isolated carpometacarpal joint involvement from either degenerative or post-traumatic arthritis presenting:
> Localized pain and palpable crepitation during circumduction movement with axial compression of involved thumb ("grind test").
> Decreased motion, normal pinch and grip strength.
> X-ray evidence of arthritic changes and/or subluxation of the carpometacarpal joint.
> Associated unstable, stiff, or painful distal joints.
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/K960659 · printed Nov 6, 2026
Cite this page
510(k) Report. “K960659: Ceramic Spherical CMC Implant (Subject to Marketing Approval).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K960659
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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