510(k) Report

510(k) · Cleared

Cleared

Arthrex Corkscrew FT Iii Suture Anchor with Three #2 Sutures

K062679510(k) SpecialCleared Sep 27, 200619-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 Sep 27, 2006 after a 19-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 6 later devices descend from it.

Decided
Sep 27, 2006
Review
19 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
1

6 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2009: 1 descendant cleared2010: 2 descendants cleared2011: 3 descendants cleared20052010201520202025
  1. This deviceK062679 Arthrex Corkscrew FT Iii Suture Anchor with Three #2 SuturesArthrex, Inc. · 2006
  2. Descendant · cites it directly · 5 of its ownK092133 Arthrocare Titanium Suture Anchor, Model 22-9055,22-9055N, 22-9065…Arthrocare Corp. · 2009
  3. Descendant · 2 generations on · 4 of its ownK101184 Titan TI Suture Anchor System, Models 22-9055, 22-9055N, 22-9065…Arthrocare Corp. · 2010
  4. Descendant · 2 generations on · 2 of its ownK102262 Arthocare Spartan Peek Suture Implant System; Punch Tap ; Extraction…Arthrocare Corp. · 2010
  5. Descendant · 3 generations on · 1 of its ownK110164 5.5MM Spartan Peek Suture Implant W/ #2 Magnum Wire, Punch Tap…Arthrocare Corp. · 2011
  6. Descendant · 2 generations on · 0 of its ownK111397 Titan TI Suture Anchor SystemArthrocare Corp. · 2011

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2009: 12010: 22011: 3
2009high 3 (2011) · low 0 (2012)2026

Most influential descendants

Showing 5 of 6 · See all
  • K092133Arthrocare Titanium Suture Anchor, Model 22-9055,22-9055N, 22-9065, 22-9065NArthrocare Corp. · 2009 · cites it directly5descendants
  • K101184Titan TI Suture Anchor System, Models 22-9055, 22-9055N, 22-9065, 22-9065N, 22-9022…Arthrocare Corp. · 2010 · 2 generations on4descendants
  • K102262Arthocare Spartan Peek Suture Implant System; Punch Tap ; Extraction ToolArthrocare Corp. · 2010 · 2 generations on2descendants
  • K1101645.5MM Spartan Peek Suture Implant W/ #2 Magnum Wire, Punch Tap, Extraction ToolArthrocare Corp. · 2011 · 3 generations on1descendant
  • K111397Titan TI Suture Anchor SystemArthrocare Corp. · 2011 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K062679Arthrex Corkscrew FT Iii Suture Anchor with Three #2 SuturesArthrex, Inc.2006—
+1K092133Arthrocare Titanium Suture Anchor, Model 22-9055,22-9055N, 22-9065, 22-9065NArthrocare Corp.2009—
+2K101184Titan TI Suture Anchor System, Models 22-9055, 22-9055N, 22-9065, 22-9065N…Arthrocare Corp.2010—
+2K102262Arthocare Spartan Peek Suture Implant System; Punch Tap ; Extraction ToolArthrocare Corp.2010—
+3K1101645.5MM Spartan Peek Suture Implant W/ #2 Magnum Wire, Punch Tap, Extraction ToolArthrocare Corp.2011—
+2K111397Titan TI Suture Anchor SystemArthrocare Corp.2011—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201020
201130
FIG. 1 — Lineage of K062679, 2006–2011Source: 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? (1)

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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

TypeNumberDeviceApplicantDecidedRecalls
Kept off the family treeK041928FDA’s K041928 is HDL-Advance Assay, Cat. NO. 278-20, 278-50A, 278-50B
Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
Diagnostic Chemicals, Ltd.2004—

What descends from it? (6)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K092133Arthrocare Titanium Suture Anchor, Model 22-9055,22-9055N, 22-9065, 22-9065NArthrocare Corp.20095

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, K092133 (Arthrocare Corp., 2009) has gone furthest, with 5 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 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-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Vaigus Reconstruction, Midfoot Reconstruction, Metatarsal…

Read the full statement (114 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-Clavicular Separation Repair, Deltoid

Repair, Capsular Shift or Capsulolabral Reconstruction

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon

Repair, Hallux Vaigus Reconstruction, Midfoot Reconstruction,

Metatarsal Ligament Repair

Knee: Medial Collateral Ugament 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 Ugament 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.

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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https://510kreport.com/device/K062679 · printed Nov 5, 2026

Cite this page

510(k) Report. “K062679: Arthrex Corkscrew FT Iii Suture Anchor with Three #2 Sutures.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K062679

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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