510(k) · Cleared

Cleared

Arthrotek Lactonail

K040500510(k) TraditionalCleared May 25, 200489-day reviewClass II21 CFR 888.3040

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

Arthrotek, Inc. · HTY Pin, Fixation, Smooth

Cleared on May 25, 2004 as substantially equivalent to K925098 (Bioscience, Inc., 1994) after an 89-day review. Its family tree reaches back 1 generation to 1994. 2 later devices descend from it.

Decided: May 25, 2004
Review: 89 days
Class: Class II
Product code: HTY
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K925098 (1994). 2 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK925098 Biofix Absorbable Self-Reinforced Poly-L-LactideBioscience, Inc. · 1994
This deviceK040500 Arthrotek LactonailArthrotek, Inc. · 2004
Descendant · cites it directly · 1 of its ownK043339 Refix Pin (Plla), Models 2070L, 2770L, 3570L, 4570L; (Plga), Models…Xtremi-T, LLC · 2005
Descendant · 2 generations on · 0 of its ownK151876 Bio2 Fusion Implant SystemBio2 Technologies, Inc. · 2015

Most influential descendants

Showing 2 of 2 · See all

K043339Refix Pin (Plla), Models 2070L, 2770L, 3570L, 4570L; (Plga), Models 2070LG, 2770LG…Xtremi-T, LLC · 2005 · cites it directly1descendant
K151876Bio2 Fusion Implant SystemBio2 Technologies, Inc. · 2015 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K925098	Biofix Absorbable Self-Reinforced Poly-L-Lactide	Bioscience, Inc.	1994	—
0 (this device)	K040500	Arthrotek Lactonail	Arthrotek, Inc.	2004	—
+1	K043339	Refix Pin (Plla), Models 2070L, 2770L, 3570L, 4570L; (Plga), Models 2070LG…	Xtremi-T, LLC	2005	—
+2	K151876	Bio2 Fusion Implant System	Bio2 Technologies, Inc.	2015	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2015	1	0

FIG. 1 — Lineage of K040500, 1994–2015Source: 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 HTY? 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 HTY device

#1 K231272 OSSIOfiber® Pin Product Family, OSSIOfiber®…score 19.3 · 14 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
*	K925098	Biofix Absorbable Self-Reinforced Poly-L-Lactide Summary page 1 …on Code: HTY Classification Name: Pin, Fixation, Smooth (888.3040) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: SmartPin TM (Bionx Implants) - K925098 Device Description: The Arthrotek® LactoN aijTm bioabsorbable bone fixation nail is constructed of a resorbable copolymer compos…	Bioscience, Inc.	1994	—

Also cleared against K925098: 2 other devices →

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K043339	Refix Pin (Plla), Models 2070L, 2770L, 3570L, 4570L; (Plga), Models 2070LG, 2770LG…	Xtremi-T, LLC	2005	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?

Its one ancestor has no recall.
Of its descendants, K043339 (Xtremi-T, LLC, 2005) has gone furthest, with 1 descendant of its own.
2 other devices also cite its predicate K925098.

How does its category compare?

All HTY devices

HTY Pin, Fixation, Smooth: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HTY

5in 2025

2007high 9 (2010) · low 1 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HTY

90in 2025

2007high 180 (2010) · low 73 (2014)2026

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

Recalls per year · HTY

2in 2022

2007high 2 (2016) · low 0 (2007)2026

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

Adverse event reports per year · HTY

39in 2025

2007high 297 (2024) · low 33 (2010)2025

MAUDE reports naming product code HTY, 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	6	112	0	46
2008	6	86	0	38
2009	2	—	1	36
2010	9	180	1	33
2011	6	82	0	164
2012	4	76	0	129
2013	4	128	0	187
2014	8	73	0	149
2015	8	101	0	121
2016	6	114	2	128
2017	5	127	0	82
2018	4	162	0	138
2019	4	93	1	222
2020	5	108	0	210
2021	5	137	0	148
2022	4	121	2	96
2023	5	146	0	153
2024	1	—	0	297
2025	5	90	0	39
2026	2	—	1	—

What is it indicated for?

The Arthrotek® LactoNail is intended for use in the fixation of fragments of fractured non-load bearing bones, osteotomies, and arthrodesis. Examples include the fixation of apical fragments, osteochondral fragments and cancellous/non-load bearing fragments.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K040500 · printed Nov 6, 2026

Cite this page

510(k) Report. “K040500: Arthrotek Lactonail.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040500

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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