510(k) · Cleared

Cleared

Eclipse Total Ankle Implant

K061749510(k) TraditionalCleared Nov 22, 2006154-day reviewClass II21 CFR 888.3110

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

Kinetikos Medical, Inc. · HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer

Cleared on Nov 22, 2006 as substantially equivalent to K020541 (Depuy, Inc., 2002) after a 154-day review. Its family tree reaches back 2 generations to 1992.

Decided: Nov 22, 2006
Review: 154 days
Class: Class II
Product code: HSN
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K920802 (1992). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK920802 Alvine Total AnkleDepuy, Inc. · 1992
1 generation backK020541 Agility Ankle Revision ProsthesisDepuy, Inc. · 2002
This deviceK061749 Eclipse Total Ankle ImplantKinetikos Medical, Inc. · 2006

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K920802	Alvine Total Ankle	Depuy, Inc.	1992	—
−1	K020541	Agility Ankle Revision Prosthesis	Depuy, Inc.	2002	—
0 (this device)	K061749	Eclipse Total Ankle Implant	Kinetikos Medical, Inc.	2006	—

FIG. 1 — Lineage of K061749, 1992–2006Source: 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 HSN? 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 HSN device

#1 K192994 Paragon 28 APEX 3D Total Ankle Replacement…score 16.8 · 8 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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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
*	K020541	Agility Ankle Revision Prosthesis Summary page 1 …8.3110 Device Product Code: 87 HSN 3. Predicate or legally marketed devices which are substantially equivalent: -Depuy Agility Total Ankle Orthopedic Implant (K020541) cleared May 20, 2002 4. Description of Device The Eclipse Total Ankle implant is intended for use in total anklejoint replace…	Depuy, Inc.	2002	—

Also cleared against K020541: 5 other devices →

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 14 years and passes through 2 companies; a new generation was cleared every 9.4 years on median.
None of the 2 ancestors has a recall.
5 other devices also cite its predicate K020541.

How does its category compare?

All HSN devices

HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HSN

3in 2025

2007high 7 (2024) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HSN

58in 2025

2007high 234 (2020) · low 58 (2025)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HSN

1in 2023

2007high 3 (2013) · low 0 (2007)2026

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

Adverse event reports per year · HSN

1,645in 2025

2007high 1,645 (2025) · low 50 (2007)2025

MAUDE reports naming product code HSN, 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	0	—	0	50
2008	0	—	0	66
2009	1	—	0	66
2010	2	—	0	120
2011	1	—	0	139
2012	2	—	0	100
2013	4	89	3	106
2014	2	—	0	65
2015	3	233	0	73
2016	3	216	1	111
2017	4	148	2	96
2018	4	89	0	187
2019	2	—	1	277
2020	6	234	0	281
2021	4	109	3	237
2022	1	—	2	453
2023	6	112	1	796
2024	7	115	0	1,095
2025	3	58	0	1,645
2026	2	—	0	—

What is it indicated for?

The Eclipse Total Ankle replacement system is intended for prosthetic replacement of the tibio-talar joint in patients affected with severe rheumatoid, post-traumatic, or degenerative arthritis. It is also intended for revision of prior ankle surgery, and is intended for use with bone cement.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K061749 · printed Nov 4, 2026

Cite this page

510(k) Report. “K061749: Eclipse Total Ankle Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061749

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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