510(k) · Cleared

Cleared

Small Hammer Toe Pin

K021828510(k) SpecialCleared Jul 1, 200227-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. · HWC Screw, Fixation, Bone

Cleared on Jul 1, 2002 as substantially equivalent to K011137 (Biomet, Inc., 2001) after a 27-day review. Its family tree reaches back 1 generation to 2001. 14 later devices descend from it.

Decided: Jul 1, 2002
Review: 27 days
Class: Class II
Product code: HWC
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K011137 (2001). 14 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK011137 Resorbable Hammertoe PinBiomet, Inc. · 2001
This deviceK021828 Small Hammer Toe PinBiomet, Inc. · 2002
Descendant · cites it directly · 13 of its ownK100414 Protoe Endosorb Small Hammer Toe PinMerete Medical GmbH · 2010
Descendant · 2 generations on · 10 of its ownK100926 Arrowhead Fixation DeviceArrow Products, Inc. · 2010
Descendant · 3 generations on · 9 of its ownK112675 Arrow-Lok Digital SystemArrowhead Medical Device Technologies, LLC · 2011 · Recalled
Descendant · 4 generations on · 4 of its ownK183055 Vector Hammertoe Correction SystemNvision Biomedical Technologies, LLC · 2019
Descendant · 5 generations on · 3 of its ownK201850 Vector Hammertoe Correction SystemNvision Biomedical Technologies, Inc. · 2020

Showing 5 of 14 descendants. See all descendants

Descendants cleared per year

2010high 3 (2010) · low 0 (2013)2026

Most influential descendants

Showing 5 of 14 · See all

K100414Protoe Endosorb Small Hammer Toe PinMerete Medical GmbH · 2010 · cites it directly13descendants
K100926Arrowhead Fixation DeviceArrow Products, Inc. · 2010 · 2 generations on10descendants
K112675Arrow-Lok Digital SystemArrowhead Medical Device Technologies, LLC · 2011 · 3 generations on9descendants
K183055Vector Hammertoe Correction SystemNvision Biomedical Technologies, LLC · 2019 · 4 generations on4descendants
K201850Vector Hammertoe Correction SystemNvision Biomedical Technologies, Inc. · 2020 · 5 generations on3descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K011137	Resorbable Hammertoe Pin	Biomet, Inc.	2001	—
0 (this device)	K021828	Small Hammer Toe Pin	Biomet, Inc.	2002	—
+1	K100414	Protoe Endosorb Small Hammer Toe Pin	Merete Medical GmbH	2010	—
+2	K100926	Arrowhead Fixation Device	Arrow Products, Inc.	2010	—
+3	K112675	Arrow-Lok Digital System	Arrowhead Medical Device Technologies, LLC	2011	1
+4	K183055	Vector Hammertoe Correction System	Nvision Biomedical Technologies, LLC	2019	—
+5	K201850	Vector Hammertoe Correction System	Nvision Biomedical Technologies, Inc.	2020	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2010	3	0
2011	1	0
2012	1	0
2014	1	0
2015	1	0
2016	1	0
2019	1	0
2020	1	0
2021	1	0
2022	1	0
2024	1	0
2025	1	0

FIG. 1 — Lineage of K021828, 2001–2025Source: 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 HWC? 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 HWC device

#1 K203011 Monster Screw Systemscore 22.2 · 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
*	K011137	Resorbable Hammertoe Pin	Biomet, Inc.	2001	—

Also cleared against K011137: 1 other device →

What descends from it? (14)

See all 14

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

Number	Device	Applicant	Decided	Descendants
K100414	Protoe Endosorb Small Hammer Toe Pin	Merete Medical GmbH	2010	13

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, K100414 (Merete Medical GmbH, 2010) has gone furthest, with 13 descendants of its own.
1 other device also cites its predicate K011137.

How does its category compare?

All HWC devices

HWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HWC

15in 2025

2007high 41 (2015) · low 15 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HWC

111in 2025

2007high 167 (2022) · low 75 (2020)2026

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

Recalls per year · HWC

1in 2025

2007high 33 (2008) · low 0 (2023)2026

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

Adverse event reports per year · HWC

2,893in 2025

2007high 5,463 (2019) · low 651 (2009)2025

MAUDE reports naming product code HWC, 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	35	77	25	669
2008	33	76	33	660
2009	27	113	29	651
2010	23	110	7	765
2011	35	88	12	1,104
2012	20	99	30	3,339
2013	25	90	14	3,850
2014	31	88	2	2,549
2015	41	85	5	2,711
2016	26	131	4	2,285
2017	40	127	4	2,561
2018	20	106	1	3,662
2019	30	108	5	5,463
2020	28	75	4	4,820
2021	26	84	2	4,446
2022	26	167	13	3,934
2023	24	104	0	3,718
2024	17	90	0	3,575
2025	15	111	1	2,893
2026	21	125	2	—

What is it indicated for?

The Small Hammer Toe Pin is indicated for proximal interphalangeal (PIP) joint arthrodesis.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K021828 · printed Nov 6, 2026

Cite this page

510(k) Report. “K021828: Small Hammer Toe Pin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021828

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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