510(k) · Cleared

Cleared

Artherx Corkscrew FT II Suture Anchor

K050358510(k) SpecialCleared Apr 15, 200560-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 Apr 15, 2005 as substantially equivalent to K003816 (Arthrex, Inc., 2001) and 1 other predicate after a 60-day review. Its family tree reaches back 1 generation to 1997. 40 later devices descend from it.

Decided: Apr 15, 2005
Review: 60 days
Class: Class II
Product code: HWC
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K971723 (1997). 2 ancestors in all. 40 later devices descend from it, 5 citing it directly.

By dateBy generation

Root · 1 generation backK971723 Fastak Suture Anchor (11.7MM)/(7.5MM)Arthrex, Inc. · 1997
This deviceK050358 Artherx Corkscrew FT II Suture AnchorArthrex, Inc. · 2005
Descendant · cites it directly · 18 of its ownK072063 KFX Tissue Fixation System and AccessoriesKfx Medical · 2007
Descendant · 2 generations on · 16 of its ownK081598 Suture Lock Nail Bone Anchor with White (KFX-W-200) & Blue…Kfx Medical · 2008
Descendant · 3 generations on · 15 of its ownK102298 Transtend BR Anchor W/ Orthocord, Transtend TI Anchor W/Orthocord…Depuy Mitek, A Johnson & Johnson Company · 2011
Descendant · cites it directly · 13 of its ownK090075 Parcus V-Lox Titanium Suture Anchor,Models: 10251, 10252, 10257, 10258Parcus Medical, LLC · 2009
Descendant · 2 generations on · 7 of its ownK091094 Parcus V-Lox Peek CF Suture Anchor, Models: 10253, 10254, 10263, 10264Parcus Medical, LLC · 2009

Showing 5 of 40 descendants. See all descendants

Descendants cleared per year

2007high 8 (2011) · low 0 (2012)2026

Most influential descendants

Showing 5 of 40 · See all

K072063KFX Tissue Fixation System and AccessoriesKfx Medical · 2007 · cites it directly18descendants
K081598Suture Lock Nail Bone Anchor with White (KFX-W-200) & Blue (KFX-B-200) Fiberforce SutureKfx Medical · 2008 · 2 generations on16descendants
K102298Transtend BR Anchor W/ Orthocord, Transtend TI Anchor W/Orthocord, Transtend Peek Anchor…Depuy Mitek, A Johnson & Johnson Company · 2011 · 3 generations on15descendants
K090075Parcus V-Lox Titanium Suture Anchor,Models: 10251, 10252, 10257, 10258Parcus Medical, LLC · 2009 · cites it directly13descendants
K091094Parcus V-Lox Peek CF Suture Anchor, Models: 10253, 10254, 10263, 10264Parcus Medical, LLC · 2009 · 2 generations on7descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K971723	Fastak Suture Anchor (11.7MM)/(7.5MM)	Arthrex, Inc.	1997	—
0 (this device)	K050358	Artherx Corkscrew FT II Suture Anchor	Arthrex, Inc.	2005	—
+1	K072063	KFX Tissue Fixation System and Accessories	Kfx Medical	2007	—
+2	K081598	Suture Lock Nail Bone Anchor with White (KFX-W-200) & Blue (KFX-B-200)…	Kfx Medical	2008	—
+3	K102298	Transtend BR Anchor W/ Orthocord, Transtend TI Anchor W/Orthocord, Transtend…	Depuy Mitek, A Johnson & Johnson Company	2011	—
+1	K090075	Parcus V-Lox Titanium Suture Anchor,Models: 10251, 10252, 10257, 10258	Parcus Medical, LLC	2009	—
+2	K091094	Parcus V-Lox Peek CF Suture Anchor, Models: 10253, 10254, 10263, 10264	Parcus Medical, LLC	2009	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0
2008	2	0
2009	3	0
2010	4	0
2011	8	0
2013	3	0
2014	3	0
2015	1	0
2018	1	0
2020	1	0
2021	3	0
2022	3	0
2023	2	0
2024	2	0
2025	1	0
2026	2	0

FIG. 1 — Lineage of K050358, 1997–2026Source: 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

Get a 510(k) Report

What was it cleared against? (2)

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
*	K003816	Arthrex Titanium Corkscrew, 3.5 MM, Arthrex Titanium Corkscrew, 5.0 MM, Arthrex Titanium… Summary page 1 …Suture, Nonabsorbable Synthetic Polyethylene PREDICATE DEVICE: Corkscrew Suture Anchor: K003816 & K971723 DEVICE DESCRIPTION AND INTENDED USE: The Arthrex Corkscrew FT II Suture Anchor is a 5.5 x 16mm fully threaded (FT) non-…	Arthrex, Inc.	2001	—
*	K971723	Fastak Suture Anchor (11.7MM)/(7.5MM) Summary page 1 …Suture, Nonabsorbable Synthetic Polyethylene PREDICATE DEVICE: Corkscrew Suture Anchor: K003816 & K971723 DEVICE DESCRIPTION AND INTENDED USE: The Arthrex Corkscrew FT II Suture Anchor is a 5.5 x 16mm fully threaded (FT) non- degradabl…	Arthrex, Inc.	1997	—

Also cleared against K003816: 2 other devices →

What descends from it? (40)

See all 40

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

Number	Device	Applicant	Decided	Descendants
K072063	KFX Tissue Fixation System and Accessories	Kfx Medical	2007	18
K090075	Parcus V-Lox Titanium Suture Anchor,Models: 10251, 10252, 10257, 10258	Parcus Medical, LLC	2009	13
K092133	Arthrocare Titanium Suture Anchor, Model 22-9055,22-9055N, 22-9065, 22-9065N	Arthrocare Corp.	2009	5
K212381	VersaTap, VersaLat, DueLock, VersaTi, MiniTi	Ortho-Design (Pty), Ltd.	2021	1
K110538	Pro Fixation System	Synovis Orthopedic & Woundcare	2011	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?

None of the 2 ancestors has a recall.
Of its descendants, K072063 (Kfx Medical, 2007) has gone furthest, with 18 descendants of its own.
2 other devices also cite its predicate K003816.

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 Arthrex Corkscrew FT Suture Anchor 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-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction. Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot…

Read the full statement (120 words)

The Arthrex Corkscrew FT Suture Anchor 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-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction.

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair.

Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, and Iliotibial Band Tenodesis.

Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction.

Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction.

Pelvis: Bladder Neck Suspension for female urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K050358 · printed Nov 6, 2026

Cite this page

510(k) Report. “K050358: Artherx Corkscrew FT II Suture Anchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050358

Report an extraction error

Are you the manufacturer?

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