510(k) · Cleared

Cleared

Resorbable Bone Pins

K011522510(k) TraditionalCleared Jul 31, 200175-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

Biomet, Inc. · HTY Pin, Fixation, Smooth

Cleared on Jul 31, 2001 after a 75-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 58 later devices descend from it.

Decided: Jul 31, 2001
Review: 75 days
Class: Class II
Product code: HTY
Recalls: None
Predicates: 0

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

This deviceK011522 Resorbable Bone PinsBiomet, Inc. · 2001
Descendant · cites it directly · 47 of its ownK012572 Soft Tissue Screw and WasherBiomet, Inc. · 2001
Descendant · cites it directly · 30 of its ownK012872 Resorbable Screw AnchorArthrotek, Inc. · 2001
Descendant · 2 generations on · 26 of its ownK041274 Resorbable Interference ScrewArthrotek, Inc. · 2004 · Recalled
Descendant · 2 generations on · 15 of its ownK032894 Osteo Acl Screw Model;237020T, 237025T, 237030T, 238020T, 238025T…Linvatec Biomaterials, Inc. · 2004
Descendant · 3 generations on · 13 of its ownK052080 Matryx Interference ScrewLinvatec Biomaterials, Inc. · 2005

Showing 5 of 58 descendants. See all descendants

Descendants cleared per year

2001high 6 (2011) · low 0 (2019)2026

Most influential descendants

Showing 5 of 58 · See all

K012572Soft Tissue Screw and WasherBiomet, Inc. · 2001 · cites it directly47descendants
K012872Resorbable Screw AnchorArthrotek, Inc. · 2001 · cites it directly30descendants
K041274Resorbable Interference ScrewArthrotek, Inc. · 2004 · 2 generations on26descendants
K032894Osteo Acl Screw Model;237020T, 237025T, 237030T, 238020T, 238025T, 238030T, 239020T…Linvatec Biomaterials, Inc. · 2004 · 2 generations on15descendants
K052080Matryx Interference ScrewLinvatec Biomaterials, Inc. · 2005 · 3 generations on13descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K011522	Resorbable Bone Pins	Biomet, Inc.	2001	—
+1	K012572	Soft Tissue Screw and Washer	Biomet, Inc.	2001	—
+1	K012872	Resorbable Screw Anchor	Arthrotek, Inc.	2001	—
+2	K041274	Resorbable Interference Screw	Arthrotek, Inc.	2004	5
+2	K032894	Osteo Acl Screw Model;237020T, 237025T, 237030T, 238020T, 238025T, 238030T…	Linvatec Biomaterials, Inc.	2004	—
+3	K052080	Matryx Interference Screw	Linvatec Biomaterials, Inc.	2005	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2001	2	0
2002	1	0
2003	1	0
2004	5	0
2005	4	0
2006	3	0
2007	5	0
2008	3	0
2009	1	0
2010	2	0
2011	6	0
2012	3	0
2013	4	0
2014	2	0
2015	2	0
2016	2	0
2017	2	0
2018	4	0
2020	4	0
2022	1	0
2023	1	0

FIG. 1 — Lineage of K011522, 2001–2023Source: 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? (58)

See all 58

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

Number	Device	Applicant	Decided	Descendants
K012572	Soft Tissue Screw and Washer	Biomet, Inc.	2001	47
K012872	Resorbable Screw Anchor	Arthrotek, Inc.	2001	30
K043339	Refix Pin (Plla), Models 2070L, 2770L, 3570L, 4570L; (Plga), Models 2070LG, 2770LG…	Xtremi-T, LLC	2005	1
K020819	Distal Radius Plating System	Biomet, Inc.	2002	1
K173616	DIP Arthrodesis System	In2bones Sas	2018	0
K071616	Arc Surgical Biotrak Pin System	Arc Surgical, LLC	2007	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?

Of its descendants, K012572 (Biomet, Inc., 2001) has gone furthest, with 47 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/K011522 · printed Nov 5, 2026

Cite this page

510(k) Report. “K011522: Resorbable Bone Pins.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K011522

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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