510(k) · Cleared

Cleared

Harpoon Suture Anchor

K071816510(k) TraditionalCleared Sep 20, 200780-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 Sports Medicine, Inc. · HWC Screw, Fixation, Bone

Cleared on Sep 20, 2007 as substantially equivalent to K973775 (Biomet, Inc., 1998) and 2 other predicates after an 80-day review. Its family tree reaches back 3 generations to 1996.

Decided: Sep 20, 2007
Review: 80 days
Class: Class II
Product code: HWC
Recalls: None
Predicates: 3

Its longest line of descent runs back 3 generations to K961555 (1996). 7 ancestors in all, the oldest K943806 (1995). No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
2 generations backK031685 Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc. · 2003 · Recalled
1 generation backK053344 Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5…Smith & Nephew, Inc. · 2006
This deviceK071816 Harpoon Suture AnchorBiomet Sports Medicine, Inc. · 2007

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K961555	Acufex Tag Bioabsorbable Anchors	Acufex Microsurgical, Inc.	1996	—
−2	K031685	Tag Rod Bioraptor Suture Anchor 7209317, 7209318	Smith & Nephew, Inc.	2003	5
−1	K053344	Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture…	Smith & Nephew, Inc.	2006	—
0 (this device)	K071816	Harpoon Suture Anchor	Biomet Sports Medicine, Inc.	2007	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	1	0
1998	2	0
2001	1	0

FIG. 1 — Lineage of K071816, 1996–2007Source: 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? (3)

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
*	K973775	Harpoon Suture Anchors Summary page 1 …urrently Ti Screw) Manufacturer Blomet Sports Medicine Smnith & Nephew Biomnet Spoits Medicine 510(k) Number K(973775 K(053344 K(012503 Device Description: The Harpoon® Suture Anchor iscomprised of either s…	Biomet, Inc.	1998	—
*	K053344	Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture Anchor Summary page 1 …acturer Blomet Sports Medicine Smnith & Nephew Biomnet Spoits Medicine 510(k) Number K(973775 K(053344 K(012503 Device Description: The Harpoon® Suture Anchor iscomprised of either stainless steel or titanium ma…	Smith & Nephew, Inc.	2006	—
*	K012503	Metal Screw Anchor Summary page 1 …rts Medicine Smnith & Nephew Biomnet Spoits Medicine 510(k) Number K(973775 K(053344 K(012503 Device Description: The Harpoon® Suture Anchor iscomprised of either stainless steel or titanium material designed with a collar…	Biomet Manufacturing, Inc.	2001	—

Also cleared against K973775: 7 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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?

The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 2.7 years on median.
2 of the 7 ancestors have a recall of any class.
7 other devices also cite its predicate K973775.

How does its category compare?

All HWC devices

HWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

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?

Harpoon® and Mini-Harpoon® Suture Anchors are indicated for use in soft tissue reattachment procedures. Specific Indications are: Shoulder - Bankart repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tenodesis, deltoid repair, and anterior shoulder instability repair Wrist - Scapholunate ligament reconstruction Elbow - Biceps tendon reattachment, Ulnar or radial…

Read the full statement (127 words)

Harpoon® and Mini-Harpoon® Suture Anchors are indicated for use in soft tissue reattachment procedures. Specific Indications are:

Shoulder - Bankart repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tenodesis, deltoid repair, and anterior shoulder instability repair

Wrist - Scapholunate ligament reconstruction

Elbow - Biceps tendon reattachment, Ulnar or radial collateral ligament reconstruction, and lateral epicondylitis repair

Knee - Extracapsular Repair (Medial collateral ligament repair, lateral collateral ligament repair, and posterior oblique ligament repair), joint capsule closure, iliotibial band tenodesis reconstruction, patellar realignment and tendon repair, and vastus medialis obliquus (VMO) muscle advancement

Foot and Ankle - Hallux valgus repairs, medial or lateral instability repair/reconstruction, Achilles tendon repair/reconstruction, midfoot reconstruction, and metatarsal ligament/tendon repair/reconstruction

Hip - Capsular Repair (acetabular labral repair)

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K071816 · printed Nov 5, 2026

Cite this page

510(k) Report. “K071816: Harpoon Suture Anchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071816

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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