510(k) · Cleared
ClearedArtelon Spacer CMC-1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Artimplant AB · KYI Prosthesis, Wrist, Carpal Trapezium
Cleared on Sep 21, 2004 as substantially equivalent to K964381 (Avanta Orthopaedics, Inc., 1997) after a 251-day review. Its family tree reaches back 1 generation to 1997. 2 later devices descend from it.
- Decided
- Sep 21, 2004
- Review
- 251 days
- Class
- Class II
- Product code
- KYI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K964381 (1997). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK964381 Avanta Orthopaedics Trapezial ImplantAvanta Orthopaedics, Inc. · 1997 · Recalled
- This deviceK040070 Artelon Spacer CMC-1Artimplant AB · 2004
- Descendant · cites it directly · 0 of its ownK061956 Artelon STT SpacerArtimplant AB · 2007
- Descendant · cites it directly · 0 of its ownK061954 Artelon CMC Spacer ArthroArtimplant AB · 2007
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K964381 | Avanta Orthopaedics Trapezial Implant | Avanta Orthopaedics, Inc. | 1997 | 1 |
| 0 (this device) | K040070 | Artelon Spacer CMC-1 | Artimplant AB | 2004 | — |
| +1 | K061956 | Artelon STT Spacer | Artimplant AB | 2007 | — |
| +1 | K061954 | Artelon CMC Spacer Arthro | Artimplant AB | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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 |
|---|---|---|---|
| * | K964381 | Avanta Orthopaedics Trapezial ImplantSummary page 1…2. Equivalent devices The Artimplant ArtelonTM Spacer CMC-I is substantially equivalent to the Avanta Orthopedics TRL Trapezium Soft Skeletal Implant (K964381) 3. Description of the Device The ArtelonTM Spacer CMC-I is a one-piece device intended to be implanted into t… | 1997 |
What descends from it? (2)
2 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?
- Its one ancestor has a recall.
- Of its descendants, K061956 (Artimplant AB, 2007) has gone furthest, with 0 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 Artelon Spacer CMC-I is intended to be implanted into the first carpometacarpal joint as an interpositional spacer between the trapezium and first metacarpal.
The device is intended to be used in thumb disabilities because of osteoarthritis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040070 · printed Nov 5, 2026
Cite this page
510(k) Report. “K040070: Artelon Spacer CMC-1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K040070
Report an extraction error
Are you the manufacturer?
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