510(k) · Cleared

Cleared

Finger Joint Prosthesis

K013629510(k) TraditionalCleared Jan 25, 200281-day reviewClass II21 CFR 888.3230

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

Avanta Orthopaedics, Inc. · KYJ Prosthesis, Finger, Constrained, Polymer

Cleared on Jan 25, 2002 as substantially equivalent to K870200 (Sutter Biomedical, Inc., 1987) after an 81-day review. Its family tree reaches back 1 generation to 1987. 1 later device descends from it.

Decided: Jan 25, 2002
Review: 81 days
Class: Class II
Product code: KYJ
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K870200 (1987). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK870200 Sutter Finger Joint ProsthesisSutter Biomedical, Inc. · 1987
This deviceK013629 Finger Joint ProsthesisAvanta Orthopaedics, Inc. · 2002
Descendant · cites it directly · 0 of its ownK140453 Osteotec Silicone Finger ImplantOsteotec, Ltd. · 2015 · Recalled

Most influential descendants

Showing 1 of 1 · See all

K140453Osteotec Silicone Finger ImplantOsteotec, Ltd. · 2015 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K870200	Sutter Finger Joint Prosthesis	Sutter Biomedical, Inc.	1987	—
0 (this device)	K013629	Finger Joint Prosthesis	Avanta Orthopaedics, Inc.	2002	—
+1	K140453	Osteotec Silicone Finger Implant	Osteotec, Ltd.	2015	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2015	1	0

FIG. 1 — Lineage of K013629, 1987–2015Source: 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 KYJ? 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 KYJ device

#1 K233670 Ascension Silicone MCP; Ascension Silicone PIPscore 7.1 · 3 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
*	K870200	Sutter Finger Joint Prosthesis Summary page 1 …ssification: Class I Reviewing Panel: Orthopedic Regulation Number 888.3230 Product Code: 87 KYJ Predicate Device: Sutter Finger Joint Prosthesis Sutter Corporation (K870200). Registration Number: 2030506 Owner Operator Number: 9001389 Device Description: The finger joint prosthesis like the predic…	Sutter Biomedical, Inc.	1987	—

Also cleared against K870200: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K140453	Osteotec Silicone Finger Implant	Osteotec, Ltd.	2015	0

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 no recall.
Of its descendants, K140453 (Osteotec, Ltd., 2015) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K870200.

How does its category compare?

All KYJ devices

KYJ Prosthesis, Finger, Constrained, Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KYJ

2in 2023

2007high 2 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KYJ

Too few KYJ 510(k)s in any year since 2007 to give a median.

Recalls per year · KYJ

1in 2019

2007high 2 (2016) · low 0 (2007)2026

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

Adverse event reports per year · KYJ

32in 2025

2007high 48 (2020) · low 6 (2016)2025

MAUDE reports naming product code KYJ, 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	9
2008	0	—	0	15
2009	2	—	0	35
2010	0	—	0	9
2011	0	—	0	11
2012	0	—	0	25
2013	0	—	0	11
2014	0	—	0	14
2015	1	—	0	18
2016	0	—	2	6
2017	0	—	0	14
2018	0	—	0	11
2019	0	—	1	26
2020	0	—	0	48
2021	0	—	0	45
2022	1	—	0	39
2023	2	—	0	24
2024	0	—	0	29
2025	0	—	0	32
2026	0	—	0	—

What is it indicated for?

Avanta Orthopaedics Finger Joint Prosthesis is intended for replacement of the Metacarpophalangeal joint of the hand which has been damaged by rheumatoid, osteo or post traumatic arthritis.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K013629 · printed Nov 4, 2026

Cite this page

510(k) Report. “K013629: Finger Joint Prosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013629

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026