510(k) · Cleared
Recalled · 2003Avanta Orthopaedics Trapezial Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Avanta Orthopaedics, Inc. · KYI Prosthesis, Wrist, Carpal Trapezium
Cleared on Jan 22, 1997 after a 79-day review. The FDA summary names its predicate without a number. 3 later devices descend from it. It has been recalled once.
- Decided
- Jan 22, 1997
- Review
- 79 days
- Class
- Class II
- Product code
- KYI
- Recalls
- 1
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK964381 Avanta Orthopaedics Trapezial ImplantAvanta Orthopaedics, Inc. · 1997
- Descendant · cites it directly · 2 of its ownK040070 Artelon Spacer CMC-1Artimplant AB · 2004
- Descendant · 2 generations on · 0 of its ownK061956 Artelon STT SpacerArtimplant AB · 2007
- Descendant · 2 generations on · 0 of its ownK061954 Artelon CMC Spacer ArthroArtimplant AB · 2007
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K964381 | Avanta Orthopaedics Trapezial Implant | Avanta Orthopaedics, Inc. | 1997 | — |
| +1 | K040070 | Artelon Spacer CMC-1 | Artimplant AB | 2004 | — |
| +2 | K061956 | Artelon STT Spacer | Artimplant AB | 2007 | — |
| +2 | K061954 | Artelon CMC Spacer Arthro | Artimplant AB | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2007 | 2 | 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 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 |
|---|---|---|---|
| * | — | Dow Corning Corporation Silastic H.P. Trapezial Implant Named without a submission number |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K040070 | Artelon Spacer CMC-1 | 2004 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 24, 2003 | Not classified | Z-0710-03 | Other | Wrong silicone elastomer used in construction. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K040070 (Artimplant AB, 2004) has gone furthest, with 2 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 device is intended to be used in the treatment of thumb disabilities because of osteoarthritis, post-traumatic arthritis, or rheumatoid arthritis as follows: Localized pain and palpable crepitation during circumduction movements with axial compression of the thumb. Loss of thumb motion with decrease of normal pinch and grip strength. Radiological evidence of arthritic changes of the trapeziometacarpal joint of the thumb or thumb and index finger in combination. Unstable, stiff, or painful distal joints of the thumb or swan-neck deformity.
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/K964381 · printed Nov 4, 2026
Cite this page
510(k) Report. “K964381: Avanta Orthopaedics Trapezial Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K964381
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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