510(k) · Cleared

Cleared

Arthrex Titanium Corkscrew, 3.5 MM, Arthrex Titanium Corkscrew, 5.0 MM, Arthrex Titanium Corkscrew 6.5MM

K003816510(k) TraditionalCleared Mar 9, 200188-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

Arthrex, Inc. · HWC Screw, Fixation, Bone

Cleared on Mar 9, 2001 after an 88-day review. The FDA summary names its predicate without a number. 66 later devices descend from it.

Decided: Mar 9, 2001
Review: 88 days
Class: Class II
Product code: HWC
Recalls: None
Predicates: 0

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

This deviceK003816 Arthrex Titanium Corkscrew, 3.5 MM, Arthrex Titanium Corkscrew, 5.0…Arthrex, Inc. · 2001
Descendant · cites it directly · 40 of its ownK050358 Artherx Corkscrew FT II Suture AnchorArthrex, Inc. · 2005
Descendant · cites it directly · 30 of its ownK060664 Fastin RC AnchorDepuy Mitek · 2006
Descendant · 2 generations on · 21 of its ownK082282 Healix TI AnchorDepuy Mitek, A Johnson & Johnson Co. · 2008
Descendant · 2 generations on · 18 of its ownK072063 KFX Tissue Fixation System and AccessoriesKfx Medical · 2007
Descendant · 3 generations on · 16 of its ownK081598 Suture Lock Nail Bone Anchor with White (KFX-W-200) & Blue…Kfx Medical · 2008

Showing 5 of 66 descendants. See all descendants

Descendants cleared per year

2005high 10 (2011) · low 0 (2016)2026

Most influential descendants

Showing 5 of 66 · See all

K050358Artherx Corkscrew FT II Suture AnchorArthrex, Inc. · 2005 · cites it directly40descendants
K060664Fastin RC AnchorDepuy Mitek · 2006 · cites it directly30descendants
K082282Healix TI AnchorDepuy Mitek, A Johnson & Johnson Co. · 2008 · 2 generations on21descendants
K072063KFX Tissue Fixation System and AccessoriesKfx Medical · 2007 · 2 generations on18descendants
K081598Suture Lock Nail Bone Anchor with White (KFX-W-200) & Blue (KFX-B-200) Fiberforce SutureKfx Medical · 2008 · 3 generations on16descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K003816	Arthrex Titanium Corkscrew, 3.5 MM, Arthrex Titanium Corkscrew, 5.0 MM…	Arthrex, Inc.	2001	—
+1	K050358	Artherx Corkscrew FT II Suture Anchor	Arthrex, Inc.	2005	—
+1	K060664	Fastin RC Anchor	Depuy Mitek	2006	—
+2	K082282	Healix TI Anchor	Depuy Mitek, A Johnson & Johnson Co.	2008	—
+2	K072063	KFX Tissue Fixation System and Accessories	Kfx Medical	2007	—
+3	K081598	Suture Lock Nail Bone Anchor with White (KFX-W-200) & Blue (KFX-B-200)…	Kfx Medical	2008	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	2	0
2006	1	0
2007	1	0
2008	3	0
2009	4	0
2010	5	0
2011	10	0
2012	1	0
2013	6	0
2014	5	0
2015	2	0
2018	1	0
2019	2	0
2020	2	0
2021	5	0
2022	3	0
2023	5	0
2024	3	0
2025	2	0
2026	3	0

FIG. 1 — Lineage of K003816, 2001–2026Source: 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? (5)

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	Recalls
*	—	ANCHORLOK Soft Tissue Anchor System Named without a submission number	—
*	—	Mitek Knotless Anchor Named without a submission number	—
*	—	Straight-in Orthopedic fixation system Named without a submission number	—
*	—	KSEA Flipptack Named without a submission number	—
*	—	Acumed Suture Anchor Named without a submission number	—

What descends from it? (66)

See all 66

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

Number	Device	Applicant	Decided	Descendants
K050358	Artherx Corkscrew FT II Suture Anchor	Arthrex, Inc.	2005	40
K060664	Fastin RC Anchor	Depuy Mitek	2006	30
K052491	Axya Model 6500 Axyaloop Self-Tapping Bone Anchor	Axya Medical, Inc.	2005	9

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, K050358 (Arthrex, Inc., 2005) has gone furthest, with 40 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	—

What is it indicated for?

The Titanium Corkscrew is intended for fixation of suture to bone. This product is intended for the following indications: Shoulder. Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-ClavicularSeparation Repair, Deltold Repair, Capsular Shiftor CapsulolabralReconstruction FootlAnkle: Lateral Stabilization,Medial Stabilization,Achilles Tendon Repair, Hallux Valgus Reconstruction,Midfoot Reconstruction,Metatarsal Ligament…

Read the full statement (95 words)

The Titanium Corkscrew is intended for fixation of suture to bone. This product is intended for the following indications:

Shoulder. Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-ClavicularSeparation Repair, Deltold Repair, Capsular Shiftor CapsulolabralReconstruction

FootlAnkle: Lateral Stabilization,Medial Stabilization,Achilles Tendon Repair, Hallux Valgus Reconstruction,Midfoot Reconstruction,Metatarsal Ligament Repair

Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, PatellarTendon Repair, PosteriorOblique LigamentRepair, and lliotibialBand Tenodesis

HandlWrist: ScapholunateLigament Reconstruction,Ulnar Collateral Ligament Reconstruction,Radial CollateralLigamentReconstruction

Elbow. Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial CollateralLigamentReconstruction

Pelvis: Bladder Neck Suspension for female urinary incontinencedue to urethralhyper mobilityor intrinsicsphincterdeficiency

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K003816 · printed Nov 6, 2026

Cite this page

510(k) Report. “K003816: Arthrex Titanium Corkscrew, 3.5 MM, Arthrex Titanium Corkscrew, 5.0 MM, Arthrex Titanium Corkscrew 6.5MM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003816

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026