510(k) · Cleared

Cleared

Alvine Total Ankle

K920802510(k) TraditionalCleared Dec 17, 1992300-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

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

Cleared on Dec 17, 1992 after a 300-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 68 later devices descend from it.

Decided: Dec 17, 1992
Review: 300 days
Class: Class II
Product code: HSN
Recalls: None
Predicates: 0

68 later devices descend from it, 6 citing it directly.

This deviceK920802 Alvine Total AnkleDepuy, Inc. · 1992
Descendant · cites it directly · 66 of its ownK020541 Agility Ankle Revision ProsthesisDepuy, Inc. · 2002
Descendant · 2 generations on · 64 of its ownK051023 Topez Total Ankle ReplacementTopez Orthopedics, Inc. · 2005 · Recalled
Descendant · 3 generations on · 56 of its ownK100886 Inbone II Total Ankle ReplacementWrightmedicaltechnologyinc · 2010 · Recalled
Descendant · cites it directly · 53 of its ownK053569 Agility LP Total Ankle ProsthesisDePuy Orthopaedics, Inc. · 2006
Descendant · 2 generations on · 52 of its ownK123954 Infinity Total Ankle SystemWrightmedicaltechnologyinc · 2013 · Recalled

Showing 5 of 68 descendants. See all descendants

Descendants cleared per year

2002high 12 (2024) · low 0 (2003)2026

Most influential descendants

Showing 5 of 68 · See all

K020541Agility Ankle Revision ProsthesisDepuy, Inc. · 2002 · cites it directly66descendants
K051023Topez Total Ankle ReplacementTopez Orthopedics, Inc. · 2005 · 2 generations on64descendants
K100886Inbone II Total Ankle ReplacementWrightmedicaltechnologyinc · 2010 · 3 generations on56descendants
K053569Agility LP Total Ankle ProsthesisDePuy Orthopaedics, Inc. · 2006 · cites it directly53descendants
K123954Infinity Total Ankle SystemWrightmedicaltechnologyinc · 2013 · 2 generations on52descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K920802	Alvine Total Ankle	Depuy, Inc.	1992	—
+1	K020541	Agility Ankle Revision Prosthesis	Depuy, Inc.	2002	—
+2	K051023	Topez Total Ankle Replacement	Topez Orthopedics, Inc.	2005	4
+3	K100886	Inbone II Total Ankle Replacement	Wrightmedicaltechnologyinc	2010	2
+1	K053569	Agility LP Total Ankle Prosthesis	DePuy Orthopaedics, Inc.	2006	—
+2	K123954	Infinity Total Ankle System	Wrightmedicaltechnologyinc	2013	2

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2005	1	0
2006	3	0
2009	1	0
2010	1	0
2011	1	0
2012	1	0
2013	4	0
2014	2	0
2015	3	0
2016	3	0
2017	4	0
2018	4	0
2019	2	0
2020	7	0
2021	4	0
2022	1	0
2023	9	0
2024	12	0
2025	3	0
2026	1	0

FIG. 1 — Lineage of K920802, 1992–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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 16.7 · 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (68)

See all 68

6 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K020541	Agility Ankle Revision Prosthesis	Depuy, Inc.	2002	66
K053569	Agility LP Total Ankle Prosthesis	DePuy Orthopaedics, Inc.	2006	53
K060544	Salto Talaris Total Ankle Prosthesis	Tornier	2006	23
K090076	Salto Talaris Total Ankle Prosthesis	Tornier	2009	21
K130533	Salto Talaris Total Ankle Prosthesis, RHS	Tornier S.A.S.	2013	16
K120906	Zimmer Trabecular Metal Total Ankle	Zimmer, Inc.	2012	1

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?

Of its descendants, K020541 (Depuy, Inc., 2002) has gone furthest, with 66 descendants of its own.

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	—

https://510kreport.com/device/K920802 · printed Nov 6, 2026

Cite this page

510(k) Report. “K920802: Alvine Total Ankle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K920802

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026