510(k) · Cleared

Cleared

Harpoon Suture Anchors

K943806510(k) TraditionalCleared Jul 3, 1995333-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 3, 1995 after a 333-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 47 later devices descend from it.

Decided: Jul 3, 1995
Review: 333 days
Class: Class II
Product code: HWC
Recalls: None
Predicates: 0

47 later devices descend from it, 4 citing it directly.

This deviceK943806 Harpoon Suture AnchorsBiomet, Inc. · 1995
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 · cites it directly · 17 of its ownK012503 Metal Screw AnchorBiomet Manufacturing, Inc. · 2001
Descendant · 3 generations on · 9 of its ownK070389 Peek Knotless AnchorsBiomet Sports Medicine, Inc. · 2007 · Recalled
Descendant · 2 generations on · 8 of its ownK033355 Lactoscrew Screw AnchorBiomet Orthopedics, Inc. · 2004

Showing 5 of 47 descendants. See all descendants

Descendants cleared per year

2001high 7 (2011) · low 0 (2012)2026

Most influential descendants

Showing 5 of 47 · See all

K012872Resorbable Screw AnchorArthrotek, Inc. · 2001 · cites it directly30descendants
K041274Resorbable Interference ScrewArthrotek, Inc. · 2004 · 2 generations on26descendants
K012503Metal Screw AnchorBiomet Manufacturing, Inc. · 2001 · cites it directly17descendants
K070389Peek Knotless AnchorsBiomet Sports Medicine, Inc. · 2007 · 3 generations on9descendants
K033355Lactoscrew Screw AnchorBiomet Orthopedics, Inc. · 2004 · 2 generations on8descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K943806	Harpoon Suture Anchors	Biomet, Inc.	1995	—
+1	K012872	Resorbable Screw Anchor	Arthrotek, Inc.	2001	—
+2	K041274	Resorbable Interference Screw	Arthrotek, Inc.	2004	5
+1	K012503	Metal Screw Anchor	Biomet Manufacturing, Inc.	2001	—
+3	K070389	Peek Knotless Anchors	Biomet Sports Medicine, Inc.	2007	1
+2	K033355	Lactoscrew Screw Anchor	Biomet Orthopedics, Inc.	2004	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2001	3	0
2002	1	0
2003	2	0
2004	4	0
2005	1	0
2006	2	0
2007	4	0
2008	1	0
2009	1	0
2010	1	0
2011	7	0
2013	5	0
2014	4	0
2015	2	0
2016	2	0
2018	1	0
2020	5	0
2023	1	0

FIG. 1 — Lineage of K943806, 1995–2023Source: 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 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?

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

What descends from it? (47)

See all 47

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

Number	Device	Applicant	Decided	Descendants
K012872	Resorbable Screw Anchor	Arthrotek, Inc.	2001	30
K012503	Metal Screw Anchor	Biomet Manufacturing, Inc.	2001	17
K071520	Renovo Suture Anchors, Models 100-2001 Thru 100-5502X	Core Essence Orthopaedics, LLC	2007	7
K012469	Resorbable NO Profile Screw and Washer	Biomet Manufacturing, Inc.	2001	4

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, K012872 (Arthrotek, Inc., 2001) has gone furthest, with 30 descendants of its own.

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	—

https://510kreport.com/device/K943806 · printed Nov 6, 2026

Cite this page

510(k) Report. “K943806: Harpoon Suture Anchors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K943806

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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