510(k) · Cleared
ClearedArthrex 4.5 MM, 5.5 MM and 6.5 MM Corkscrew FT
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrex, Inc. · HWC Screw, Fixation, Bone
Cleared on Jul 25, 2006 as substantially equivalent to K043337 (Arthrex, Inc., 2004) after a 41-day review. Its family tree reaches back 2 generations to 2000. 114 later devices descend from it.
- Decided
- Jul 25, 2006
- Review
- 41 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K990987 (2000). 3 ancestors in all. 114 later devices descend from it, 14 citing it directly.
- Root · 2 generations backK990987 Bio-Absorbable Corkscrew, Model AR-1920BArthrex, Inc. · 2000
- 1 generation backK043337 Arthrex Bio-Corkscrew FT Suture AnchorArthrex, Inc. · 2004
- This deviceK061665 Arthrex 4.5 MM, 5.5 MM and 6.5 MM Corkscrew FTArthrex, Inc. · 2006
- Descendant · cites it directly · 49 of its ownK112111 Acu-Sinch Repair System and Acumed Suture AnchorAcumed, LLC · 2011
- Descendant · 2 generations on · 40 of its ownK113760 Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2012
- Descendant · 3 generations on · 21 of its ownK132502 Variax 2 SystemStryker Trauma AG · 2013
- Descendant · 4 generations on · 19 of its ownK140769 Variax 2 SystemStryker Trauma AG · 2014
- Descendant · 3 generations on · 16 of its ownK130116 Superior Lateral Variax Clavicle PlateStryker Trauma AG · 2013
Showing 5 of 114 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 114 · See all- K112111Acu-Sinch Repair System and Acumed Suture AnchorAcumed, LLC · 2011 · cites it directly49descendants
- K113760Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates Variax Aiming Blocks…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2012 · 2 generations on40descendants
- K132502Variax 2 SystemStryker Trauma AG · 2013 · 3 generations on21descendants
- K140769Variax 2 SystemStryker Trauma AG · 2014 · 4 generations on19descendants
- K130116Superior Lateral Variax Clavicle PlateStryker Trauma AG · 2013 · 3 generations on16descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K990987 | Bio-Absorbable Corkscrew, Model AR-1920B | Arthrex, Inc. | 2000 | — |
| −1 | K043337 | Arthrex Bio-Corkscrew FT Suture Anchor | Arthrex, Inc. | 2004 | — |
| 0 (this device) | K061665 | Arthrex 4.5 MM, 5.5 MM and 6.5 MM Corkscrew FT | Arthrex, Inc. | 2006 | — |
| +1 | K112111 | Acu-Sinch Repair System and Acumed Suture Anchor | Acumed, LLC | 2011 | — |
| +2 | K113760 | Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates Variax… | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2012 | — |
| +3 | K132502 | Variax 2 System | Stryker Trauma AG | 2013 | — |
| +4 | K140769 | Variax 2 System | Stryker Trauma AG | 2014 | — |
| +3 | K130116 | Superior Lateral Variax Clavicle Plate | Stryker Trauma AG | 2013 | — |
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 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 6 | 0 |
| 2012 | 3 | 0 |
| 2013 | 4 | 0 |
| 2014 | 4 | 0 |
| 2015 | 4 | 0 |
| 2016 | 1 | 0 |
| 2017 | 5 | 0 |
| 2018 | 11 | 0 |
| 2019 | 5 | 0 |
| 2020 | 5 | 0 |
| 2021 | 4 | 0 |
| 2022 | 8 | 0 |
| 2023 | 8 | 0 |
| 2024 | 15 | 0 |
| 2025 | 12 | 0 |
| 2026 | 11 | 0 |
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
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K043337 | Arthrex Bio-Corkscrew FT Suture AnchorSummary page 1…Suture, Nonabsorbable Synthetic Polyethylene PREDICATE DEVICE: Arthrex Bio-Corkscrew FT, 5.5 mm: K043337 DEVICE DESCRIPTION AND INTENDED USE: The Arthrex Corkscrew FT with a suture eyelet molded or internally fixed and a fully threade… | 2004 |
What descends from it? (114)
See all 11414 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K112111 | Acu-Sinch Repair System and Acumed Suture Anchor | 2011 | 49 |
| K113274 | Footprint Ultra PK Suture Anchor | 2012 | 16 |
| K112526 | Twinfix Ultra TI, Twinfix Ultra PK, Twinfix Ultra HA Suture Anchors | 2012 | 13 |
| K071157 | Stryker Peek and Titanium Soft Eyelet Anchors | 2007 | 12 |
| K080335 | Tornier Cinch Knotless Fixation Implant System | 2008 | 7 |
| K173788 | Arthrex Corkscrew FT | 2018 | 5 |
| K092133 | Arthrocare Titanium Suture Anchor, Model 22-9055,22-9055N, 22-9065, 22-9065N | 2009 | 5 |
| K180464 | AEVUMED PHANTOM Suture Anchors | 2018 | 4 |
| K152236 | KATOR Suture Anchor | 2015 | 4 |
| K070758 | Stryker Peek Zip Suture Anchor | 2007 | 2 |
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?
- The line of descent spans 6 years and passes through 1 company; a new generation was cleared every 4.9 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K112111 (Acumed, LLC, 2011) has gone furthest, with 49 descendants of its own.
- 3 other devices also cite its predicate K043337.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HWC
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HWC
111in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HWC
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HWC
2,893in 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 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…
Read the full statement (130 words)
The Arthrex 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.
https://510kreport.com/device/K061665 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061665: Arthrex 4.5 MM, 5.5 MM and 6.5 MM Corkscrew FT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061665
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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