510(k) Report

510(k) · Cleared

Cleared

4.0 MM Arthrex Bio-Tendoesis Screw, Model AR-1540B; 5.5 MM Arthrex Bio-Tenodesis Screw, Models AR-1555B

K020043510(k) TraditionalCleared Apr 2, 200285-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 2, 2002 after an 85-day review. The FDA summary names no predicate by number. 20 later devices descend from it.

Decided
Apr 2, 2002
Review
85 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
0

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

Descendants, by year cleared 2012: 2 descendants cleared2011: 3 descendants cleared2013: 5 descendants cleared2024: 3 descendants cleared2025: 1 descendant cleared2017: 1 descendant cleared2018: 1 descendant cleared2019: 2 descendants cleared2021: 1 descendant cleared2023: 1 descendant cleared200020052010201520202025
  1. This deviceK020043 4.0 MM Arthrex Bio-Tendoesis Screw, Model AR-1540B; 5.5 MM Arthrex…Arthrex, Inc. · 2002
  2. Descendant · cites it directly · 18 of its ownK103831 Depuy Mitek Milagro Interference Screw Model 231803, 231804, 231807…Depuy Mitek, A Johnson & Johnson Company · 2011
  3. Descendant · 2 generations on · 13 of its ownK112249 Healix Knotless (TM) AnchorDepuy Mitek, A Johnson & Johnson Company · 2011
  4. Descendant · 3 generations on · 9 of its ownK130917 Healix Advance Knotless BR AnchorDepuy Mitek, A Johnson & Johnson Company · 2013 · Recalled
  5. Descendant · 3 generations on · 4 of its ownK130539 Healix Advance Knotless Peek Anchor (4.75MM)(5.5MM)Depuy Mitek, A Johnson & Johnson Company · 2013
  6. Descendant · 4 generations on · 3 of its ownK131974 Healix Advance Knotless BR Anchor (6.5MM)Depuy Mitek, A Johnson & Johnson Company · 2013

Showing 5 of 20 descendants. See all descendants

Descendants cleared per year

2011: 32012: 22013: 52017: 12018: 12019: 22021: 12023: 12024: 32025: 1
2011high 5 (2013) · low 0 (2014)2026

Most influential descendants

Showing 5 of 20 · See all
  • K103831Depuy Mitek Milagro Interference Screw Model 231803, 231804, 231807, 231809Depuy Mitek, A Johnson & Johnson Company · 2011 · cites it directly18descendants
  • K112249Healix Knotless (TM) AnchorDepuy Mitek, A Johnson & Johnson Company · 2011 · 2 generations on13descendants
  • K130917Healix Advance Knotless BR AnchorDepuy Mitek, A Johnson & Johnson Company · 2013 · 3 generations on9descendants
  • K130539Healix Advance Knotless Peek Anchor (4.75MM)(5.5MM)Depuy Mitek, A Johnson & Johnson Company · 2013 · 3 generations on4descendants
  • K131974Healix Advance Knotless BR Anchor (6.5MM)Depuy Mitek, A Johnson & Johnson Company · 2013 · 4 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K0200434.0 MM Arthrex Bio-Tendoesis Screw, Model AR-1540B; 5.5 MM Arthrex…Arthrex, Inc.2002—
+1K103831Depuy Mitek Milagro Interference Screw Model 231803, 231804, 231807, 231809Depuy Mitek, A Johnson & Johnson Company2011—
+2K112249Healix Knotless (TM) AnchorDepuy Mitek, A Johnson & Johnson Company2011—
+3K130917Healix Advance Knotless BR AnchorDepuy Mitek, A Johnson & Johnson Company20132
+3K130539Healix Advance Knotless Peek Anchor (4.75MM)(5.5MM)Depuy Mitek, A Johnson & Johnson Company2013—
+4K131974Healix Advance Knotless BR Anchor (6.5MM)Depuy Mitek, A Johnson & Johnson Company2013—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201130
201220
201350
201710
201810
201920
202110
202310
202430
202510
FIG. 1 — Lineage of K020043, 2002–2025Source: 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 22.3 · 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?

The FDA summary names no predicate by number.

What descends from it? (20)

See all 20

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

NumberDeviceApplicantDecidedDescendants
K103831Depuy Mitek Milagro Interference Screw Model 231803, 231804, 231807, 231809Depuy Mitek, A Johnson & Johnson Company201118
K130716Bioretec Activascrew InterferenceBioretec, Ltd.20130
K122869Milagro Interference ScrewsDepuy Mitek, A Johnson & Johnson Company20120

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, K103831 (Depuy Mitek, A Johnson & Johnson Company, 2011) has gone furthest, with 18 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

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-Tenodesis Screw is a bioabsorbable polylactide (PLLA) screw intended to provide fixation of ligament and tendon graft tissue in surgeries of the shoulder, elbow, foot/ankle, and hand/wrist. Specifically; 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…

Read the full statement (92 words)

The Arthrex Bio-Tenodesis Screw is a bioabsorbable polylactide (PLLA) screw intended to provide fixation of ligament and tendon graft tissue in surgeries of the shoulder, elbow, foot/ankle, and hand/wrist. Specifically;

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

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

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

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

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

Recent decisions in HWC

The HWC category page

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  • K262975Arthrex Beaming SystemArthrex, Inc. · 2026
  • K260995DynaNail Helix® Fixation SystemMedShape, Inc. · 2026
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https://510kreport.com/device/K020043 · printed Nov 3, 2026

Cite this page

510(k) Report. “K020043: 4.0 MM Arthrex Bio-Tendoesis Screw, Model AR-1540B; 5.5 MM Arthrex Bio-Tenodesis Screw, Models AR-1555B.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K020043

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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