510(k) Report

510(k) · Cleared

Cleared

Arthrex Bio-Corkscrew FT Suture Anchor

K043337510(k) SpecialCleared Dec 14, 200411-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 Dec 14, 2004 as substantially equivalent to K003227 (Arthrex, Inc., 2001) and 1 other predicate after an 11-day review. Its family tree reaches back 1 generation to 2000. 145 later devices descend from it.

Decided
Dec 14, 2004
Review
11 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K990987 (2000). 2 ancestors in all. 145 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 1 other ancestor2007: 3 descendants cleared2006: 2 descendants cleared2017: 9 descendants cleared2011: 6 descendants cleared2021: 8 descendants cleared2018: 11 descendants cleared2015: 4 descendants cleared2008: 2 descendants cleared2009: 2 descendants cleared2012: 5 descendants cleared2025: 15 descendants cleared2020: 9 descendants cleared2014: 5 descendants cleared2010: 2 descendants cleared2022: 9 descendants cleared2019: 5 descendants cleared2013: 4 descendants cleared2016: 1 descendant cleared2026: 14 descendants cleared2023: 13 descendants cleared2024: 16 descendants clearedK990987 · Bio-Absorbable Corkscrew, Model AR-1920B · Arthrex, Inc. · 2000200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 4 descendants2 generations forward: 18 descendants3 generations forward: 33 descendants4 generations forward: 31 descendants5 generations forward: 25 descendants6 generations forward: 8 descendants7 generations forward: 8 descendants8 generations forward: 8 descendants9 generations forward: 5 descendants10 generations forward: 5 descendants K990987 · Bio-Absorbable Corkscrew, Model AR-1920B · Arthrex, Inc. · 20000+5+10
  1. Root · 1 generation backK990987 Bio-Absorbable Corkscrew, Model AR-1920BArthrex, Inc. · 2000
  2. This deviceK043337 Arthrex Bio-Corkscrew FT Suture AnchorArthrex, Inc. · 2004
  3. Descendant · cites it directly · 114 of its ownK061665 Arthrex 4.5 MM, 5.5 MM and 6.5 MM Corkscrew FTArthrex, Inc. · 2006
  4. Descendant · 2 generations on · 49 of its ownK112111 Acu-Sinch Repair System and Acumed Suture AnchorAcumed, LLC · 2011
  5. Descendant · 3 generations on · 40 of its ownK113760 Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2012
  6. Descendant · cites it directly · 35 of its ownK070882 Stryker Peek Twinloop TacStryker Endoscopy · 2007
  7. Descendant · 2 generations on · 27 of its ownK120509 Stryker All Suture AnchorsStryker · 2012

Showing 5 of 145 descendants. See all descendants

Descendants cleared per year

2006: 22007: 32008: 22009: 22010: 22011: 62012: 52013: 42014: 52015: 42016: 12017: 92018: 112019: 52020: 92021: 82022: 92023: 132024: 162025: 152026: 14
2006high 16 (2024) · low 1 (2016)2026

Most influential descendants

Showing 5 of 145 · See all
  • K061665Arthrex 4.5 MM, 5.5 MM and 6.5 MM Corkscrew FTArthrex, Inc. · 2006 · cites it directly114descendants
  • K112111Acu-Sinch Repair System and Acumed Suture AnchorAcumed, LLC · 2011 · 2 generations on49descendants
  • K113760Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates Variax Aiming Blocks…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2012 · 3 generations on40descendants
  • K070882Stryker Peek Twinloop TacStryker Endoscopy · 2007 · cites it directly35descendants
  • K120509Stryker All Suture AnchorsStryker · 2012 · 2 generations on27descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K990987Bio-Absorbable Corkscrew, Model AR-1920BArthrex, Inc.2000—
0 (this device)K043337Arthrex Bio-Corkscrew FT Suture AnchorArthrex, Inc.2004—
+1K061665Arthrex 4.5 MM, 5.5 MM and 6.5 MM Corkscrew FTArthrex, Inc.2006—
+2K112111Acu-Sinch Repair System and Acumed Suture AnchorAcumed, LLC2011—
+3K113760Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates Variax…Howmedica Osteonics Corp., Dba Stryker Orthopaedics2012—
+1K070882Stryker Peek Twinloop TacStryker Endoscopy2007—
+2K120509Stryker All Suture AnchorsStryker2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200620
200730
200820
200920
201020
201160
201250
201340
201450
201540
201610
201790
2018110
201950
202090
202180
202290
2023130
2024160
2025150
2026140
FIG. 1 — Lineage of K043337, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K203011 Monster Screw Systemscore 22.2 · 14 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #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.

TypeNumberDeviceApplicantDecidedRecalls
*K003227Bio-Absorbable Corkscrew Model AR-1920B
Summary page 1
…21 ~CFR 888.~5000 Suture, Nonabsorbable Synthetic Polyethylene PREDICATE DEVICE: Bio-Corkscrew Suture Anchor: K003227 & K990987 DEVICE DESCRIPTION AND INTENDED USE: (FT)…
Arthrex, Inc.2001—
*K990987Bio-Absorbable Corkscrew, Model AR-1920B
Summary page 1
…CFR 888.~5000 Suture, Nonabsorbable Synthetic Polyethylene PREDICATE DEVICE: Bio-Corkscrew Suture Anchor: K003227 & K990987 DEVICE DESCRIPTION AND INTENDED USE: (FT) PLLA bioa…
Arthrex, Inc.2000—

Also cleared against K003227: 7 other devices →

What descends from it? (145)

See all 145

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

NumberDeviceApplicantDecidedDescendants
K061665Arthrex 4.5 MM, 5.5 MM and 6.5 MM Corkscrew FTArthrex, Inc.2006114
K070882Stryker Peek Twinloop TacStryker Endoscopy200735
K171299Fixone Biocomposite AnchorAju Pharm Co., Ltd.20174
K061949Doubleplay Suture AnchorBiocomposites, Ltd.20060

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, K061665 (Arthrex, Inc., 2006) has gone furthest, with 114 descendants of its own.
  • 7 other devices also cite its predicate K003227.

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

2007: 352008: 332009: 272010: 232011: 352012: 202013: 252014: 312015: 412016: 262017: 402018: 202019: 302020: 282021: 262022: 262023: 242024: 172025: 152026 (partial year): 21
2007high 41 (2015) · low 15 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HWC

111in 2025

2007: 77 days median2008: 76 days median2009: 113 days median2010: 110 days median2011: 88 days median2012: 99 days median2013: 90 days median2014: 88 days median2015: 85 days median2016: 131 days median2017: 127 days median2018: 106 days median2019: 108 days median2020: 75 days median2021: 84 days median2022: 167 days median2023: 104 days median2024: 90 days median2025: 111 days median2026 (partial year): 125 days median
2007high 167 (2022) · low 75 (2020)2026

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

Recalls per year · HWC

1in 2025

2007: 252008: 332009: 292010: 72011: 122012: 302013: 142014: 22015: 52016: 42017: 42018: 12019: 52020: 42021: 22022: 132025: 12026 (partial year): 2
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

2007: 6692008: 6602009: 6512010: 7652011: 1,1042012: 3,3392013: 3,8502014: 2,5492015: 2,7112016: 2,2852017: 2,5612018: 3,6622019: 5,4632020: 4,8202021: 4,4462022: 3,9342023: 3,7182024: 3,5752025: 2,893
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007357725669
2008337633660
20092711329651
2010231107765
20113588121,104
20122099303,339
20132590143,850
2014318822,549
2015418552,711
20162613142,285
20174012742,561
20182010613,662
20193010855,463
2020287544,820
2021268424,446
202226167133,934
20232410403,718
2024179003,575
20251511112,893
2026211252—

What is it indicated for?

The Arthrex Bio-Corkscrew FT Suture Anchor is intended for fixation of suture to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and pelvis in, but not limited to, the following procedures: 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…

Read the full statement (130 words)

The Arthrex Bio-Corkscrew FT Suture Anchor is intended for fixation of suture to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and pelvis in, but not limited to, the following procedures:

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: Anterior Cruciate Ligament Repair, 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, Ulnar or Radial Collateral Ligament Reconstruction.

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

Indications for use as stated in the FDA summary.

Also cleared against K003227

7 other devices cite the same predicate.

  • K060830Milagro Interference ScrewDepuy Mitek, A Johnson & Johnson Company · 2006
  • K060271Spiralok AnchorDepuy Mitek, A Johnson & Johnson Company · 200616 recalls
  • K052776Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models AR-2257, AR-TBDArthrex, Inc. · 2005
  • K051250Axya, Model 6500 Axyaloop Bio-Absorbable Bone AnchorAxya Medical, Inc. · 2005
  • K041698Axya Medical, Inc. Model 5000 Axyaloop Bio-Absorbable Bone AnchorAxya Medical, Inc. · 2004
  • K030388Impact Suture Anchor. Model 433510Bionx Implants, Ltd. · 2003

More from Arthrex, Inc.

355 FDA decisions under this applicant name. See the company

  • K262975Arthrex Beaming SystemArthrex, Inc. · 2026
  • K262618Arthrex Spine Compression FT ScrewArthrex, Inc. · 2026
  • K262451Arthrex DynaNite StaplesArthrex, Inc. · 2026
  • K262357Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc. · 2026
  • K260624Arthrex Radial Head Replacement SystemArthrex, Inc. · 2026

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https://510kreport.com/device/K043337 · printed Nov 4, 2026

Cite this page

510(k) Report. “K043337: Arthrex Bio-Corkscrew FT Suture Anchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K043337

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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