510(k) · Cleared

Cleared

Artelon CMC Spacer Arthro

K061954510(k) SpecialCleared Jun 1, 2007325-day reviewClass II21 CFR 888.3770

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Artimplant AB · KYI Prosthesis, Wrist, Carpal Trapezium

Cleared on Jun 1, 2007 as substantially equivalent to K040070 (Artimplant AB, 2004) after a 325-day review. Its family tree reaches back 2 generations to 1997.

Decided: Jun 1, 2007
Review: 325 days
Class: Class II
Product code: KYI
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K964381 (1997). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK964381 Avanta Orthopaedics Trapezial ImplantAvanta Orthopaedics, Inc. · 1997 · Recalled
1 generation backK040070 Artelon Spacer CMC-1Artimplant AB · 2004
This deviceK061954 Artelon CMC Spacer ArthroArtimplant AB · 2007

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K964381	Avanta Orthopaedics Trapezial Implant	Avanta Orthopaedics, Inc.	1997	1
−1	K040070	Artelon Spacer CMC-1	Artimplant AB	2004	—
0 (this device)	K061954	Artelon CMC Spacer Arthro	Artimplant AB	2007	—

FIG. 1 — Lineage of K061954, 1997–2007Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K040070	Artelon Spacer CMC-1 Summary page 1 …Status: Class II per Regulation §888.3770 Product Code: KYI, wrist joint carpal trapezium polymer prosthesis 2. Equivalent device ARTELON CMC Spacer, K040070, 09/21/2004. 3. Description of the Device ARTELON CMC Spacer Arthro is a woven textile device made of ARTELON fibres. ARTELO…	Artimplant AB	2004	—

Also cleared against K040070: 1 other device →

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 10 years and passes through 2 companies; a new generation was cleared every 7.7 years on median.
1 of the 2 ancestors has a recall of any class.
1 other device also cites its predicate K040070.

How does its category compare?

All KYI devices

KYI Prosthesis, Wrist, Carpal Trapezium: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · KYI

1in 2020

2007high 2 (2007) · low 0 (2008)2026

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

2007high 2 (2010) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KYI

1in 2024

2007high 72 (2011) · low 0 (2015)2025

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?

Artelon® CMC Spacer Arthro intended to be implanted into the first carpometacarpal joint (CMC-I) as an interpositional spacer between the trapezial bone and the first metacarpal bone. The device is intended to be used in thumb disabilities caused by osteoarthritis.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K061954 · printed Nov 6, 2026

Cite this page

510(k) Report. “K061954: Artelon CMC Spacer Arthro.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061954

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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