510(k) · Cleared

Cleared

Biofix Absorbable Self-Reinforced Poly-L-Lactide

K925098510(k) TraditionalCleared Jul 19, 1994649-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

Bioscience, Inc. · HTY Pin, Fixation, Smooth

Cleared on Jul 19, 1994 after a 649-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 11 later devices descend from it.

Decided: Jul 19, 1994
Review: 649 days
Class: Class II
Product code: HTY
Recalls: None
Predicates: 0

11 later devices descend from it, 3 citing it directly.

This deviceK925098 Biofix Absorbable Self-Reinforced Poly-L-LactideBioscience, Inc. · 1994
Descendant · cites it directly · 7 of its ownK993074 Smart Nail Models 521516, 521520,521525, 531516, 531520. 531525Bionx Implants, Ltd. · 1999
Descendant · 2 generations on · 5 of its ownK012000 1.5MM Bone Fixation KitBionx Implants, Ltd. · 2001
Descendant · 2 generations on · 4 of its ownK013546 Modification to: 1.5 Bone Fixation Kit, Models BXS6114, BXS6214Bionx Implants, Inc. · 2001
Descendant · 2 generations on · 3 of its ownK031981 2.4 Smartnail, Models 532416, 532425, 532435, 532445Linvatec Biomaterials, Ltd. · 2003
Descendant · 2 generations on · 2 of its ownK041288 Modification to SmartpinLinvatec Biomaterials, Inc. · 2004

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

1999high 2 (2001) · low 0 (2000)2026

Most influential descendants

Showing 5 of 11 · See all

K993074Smart Nail Models 521516, 521520,521525, 531516, 531520. 531525Bionx Implants, Ltd. · 1999 · cites it directly7descendants
K0120001.5MM Bone Fixation KitBionx Implants, Ltd. · 2001 · 2 generations on5descendants
K013546Modification to: 1.5 Bone Fixation Kit, Models BXS6114, BXS6214Bionx Implants, Inc. · 2001 · 2 generations on4descendants
K0319812.4 Smartnail, Models 532416, 532425, 532435, 532445Linvatec Biomaterials, Ltd. · 2003 · 2 generations on3descendants
K041288Modification to SmartpinLinvatec Biomaterials, Inc. · 2004 · 2 generations on2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K925098	Biofix Absorbable Self-Reinforced Poly-L-Lactide	Bioscience, Inc.	1994	—
+1	K993074	Smart Nail Models 521516, 521520,521525, 531516, 531520. 531525	Bionx Implants, Ltd.	1999	—
+2	K012000	1.5MM Bone Fixation Kit	Bionx Implants, Ltd.	2001	—
+2	K013546	Modification to: 1.5 Bone Fixation Kit, Models BXS6114, BXS6214	Bionx Implants, Inc.	2001	—
+2	K031981	2.4 Smartnail, Models 532416, 532425, 532435, 532445	Linvatec Biomaterials, Ltd.	2003	—
+2	K041288	Modification to Smartpin	Linvatec Biomaterials, Inc.	2004	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0
2001	2	0
2003	1	0
2004	2	0
2005	1	0
2007	2	0
2008	1	0
2015	1	0

FIG. 1 — Lineage of K925098, 1994–2015Source: 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 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?

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

What descends from it? (11)

See all 11

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

Number	Device	Applicant	Decided	Descendants
K993074	Smart Nail Models 521516, 521520,521525, 531516, 531520. 531525	Bionx Implants, Ltd.	1999	7
K040500	Arthrotek Lactonail	Arthrotek, Inc.	2004	2
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?

Of its descendants, K993074 (Bionx Implants, Ltd., 1999) has gone furthest, with 7 descendants of its own.

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	—

https://510kreport.com/device/K925098 · printed Nov 4, 2026

Cite this page

510(k) Report. “K925098: Biofix Absorbable Self-Reinforced Poly-L-Lactide.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K925098

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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