510(k) · Cleared

Cleared

Artelon STT Spacer

K061956510(k) TraditionalCleared Jun 7, 2007331-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 7, 2007 as substantially equivalent to K040070 (Artimplant AB, 2004) after a 331-day review. Its family tree reaches back 2 generations to 1997.

Decided: Jun 7, 2007
Review: 331 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 deviceK061956 Artelon STT SpacerArtimplant 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)	K061956	Artelon STT Spacer	Artimplant AB	2007	—

FIG. 1 — Lineage of K061956, 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? (2)

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 …Classification Status: 888.3770 Product Code: KYI 2. Equivalent devices We believe that the ARTELON STT Spacer is substantially equivalent to: K040070 Artelon® CMC Spacer Artimplant AB Pre-amendment device, Swanson Trapezium Implant, Dow Coming Wright 3. Description of the…	Artimplant AB	2004	—
*	—	Swanson Trapezium Implant Named without a submission number			—

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 STT Spacer is intended to be implanted into the scaphotrapeziotrapezioidal (STT) joint as an interpositional spacer between the scaphoid bone and the trapezial-trapezioid bones. 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/K061956 · printed Nov 5, 2026

Cite this page

510(k) Report. “K061956: Artelon STT Spacer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061956

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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