510(k) · Cleared
ClearedArthrex Corkscrew Suture Anchor, Tak, and Pushlock Family
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 Oct 19, 2006 as substantially equivalent to K053344 (Smith & Nephew, Inc., 2006) after a 111-day review. Its family tree reaches back 3 generations to 1996. 283 later devices descend from it.
- Decided
- Oct 19, 2006
- Review
- 111 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K961555 (1996). 4 ancestors in all. 283 later devices descend from it, 34 citing it directly.
- Root · 3 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
- 2 generations backK031685 Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc. · 2003 · Recalled
- 1 generation backK053344 Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5…Smith & Nephew, Inc. · 2006
- This deviceK061863 Arthrex Corkscrew Suture Anchor, Tak, and Pushlock FamilyArthrex, Inc. · 2006
- Descendant · cites it directly · 227 of its ownK071177 Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock…Arthrex, Inc. · 2007
- Descendant · 2 generations on · 159 of its ownK082810 Arthrex Bio-Composite Suture Anchors: Arthrex Bio-Composite…Arthrex, Inc. · 2009
- Descendant · cites it directly · 103 of its ownK101823 Arthrex Swivelock AnchorsArthrex, Inc. · 2011 · Recalled
- Descendant · 2 generations on · 100 of its ownK091844 Arthrex Bio-Composite Suturetak AnchorsArthrex, Inc. · 2009
- Descendant · cites it directly · 77 of its ownK112237 Microsuture AnchorsArthrex, Inc. · 2011
Showing 5 of 283 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 283 · See all- K071177Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock, Bio-Composite Tak…Arthrex, Inc. · 2007 · cites it directly227descendants
- K082810Arthrex Bio-Composite Suture Anchors: Arthrex Bio-Composite Pushlock, Bio-Composite Tak…Arthrex, Inc. · 2009 · 2 generations on159descendants
- K101823Arthrex Swivelock AnchorsArthrex, Inc. · 2011 · cites it directly103descendants
- K091844Arthrex Bio-Composite Suturetak AnchorsArthrex, Inc. · 2009 · 2 generations on100descendants
- K112237Microsuture AnchorsArthrex, Inc. · 2011 · cites it directly77descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K961555 | Acufex Tag Bioabsorbable Anchors | Acufex Microsurgical, Inc. | 1996 | — |
| −2 | K031685 | Tag Rod Bioraptor Suture Anchor 7209317, 7209318 | Smith & Nephew, Inc. | 2003 | 5 |
| −1 | K053344 | Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture… | Smith & Nephew, Inc. | 2006 | — |
| 0 (this device) | K061863 | Arthrex Corkscrew Suture Anchor, Tak, and Pushlock Family | Arthrex, Inc. | 2006 | — |
| +1 | K071177 | Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock, Bio-Composite… | Arthrex, Inc. | 2007 | — |
| +2 | K082810 | Arthrex Bio-Composite Suture Anchors: Arthrex Bio-Composite Pushlock… | Arthrex, Inc. | 2009 | — |
| +1 | K101823 | Arthrex Swivelock Anchors | Arthrex, Inc. | 2011 | 6 |
| +2 | K091844 | Arthrex Bio-Composite Suturetak Anchors | Arthrex, Inc. | 2009 | — |
| +1 | K112237 | Microsuture Anchors | Arthrex, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 0 |
| 2008 | 4 | 0 |
| 2009 | 7 | 0 |
| 2010 | 8 | 0 |
| 2011 | 18 | 0 |
| 2012 | 7 | 0 |
| 2013 | 12 | 0 |
| 2014 | 14 | 0 |
| 2015 | 9 | 0 |
| 2016 | 6 | 0 |
| 2017 | 12 | 0 |
| 2018 | 16 | 0 |
| 2019 | 17 | 0 |
| 2020 | 21 | 0 |
| 2021 | 13 | 0 |
| 2022 | 15 | 0 |
| 2023 | 33 | 0 |
| 2024 | 16 | 0 |
| 2025 | 26 | 0 |
| 2026 | 27 | 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 |
|---|---|---|---|
| * | K053344 | Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture AnchorSummary page 1…They are offered in several different shapes and sizes. They are offered sterile. Predicate Devices; The indication of hip labral repair is substantially equivalent to K053344, Smith & Nephew BioRaptor 2.9 mm and TwinFix Ti 2.8 & 3.5 mm implants. Indications for Use: Please see individual indications… | 2006 |
What descends from it? (283)
See all 28334 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071177 | Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock, Bio-Composite Tak… | 2007 | 227 |
| K101823 | Arthrex Swivelock Anchors | 2011 | 103 |
| K112237 | Microsuture Anchors | 2011 | 77 |
| K140855 | Arthrex Suturetak Suture Anchors | 2014 | 63 |
| K101679 | Arthrex Pushlock Anchors | 2010 | 41 |
| K070882 | Stryker Peek Twinloop Tac | 2007 | 35 |
| K072291 | Conmed Linvatec Bio Mini-Revo Suture Anchor | 2008 | 25 |
| K191226 | Arthrex SwiveLock Suture Anchor | 2019 | 21 |
| K081893 | Opus Magnum Speedscrew Knotless Fixation Device, Model OM-6500 | 2008 | 16 |
| K112249 | Healix Knotless (TM) Anchor | 2011 | 13 |
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 10 years and passes through 3 companies; a new generation was cleared every 2.7 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K071177 (Arthrex, Inc., 2007) has gone furthest, with 227 descendants of its own.
- 15 other devices also cite its predicate K053344.
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 Family of Suture Anchors has been previously cleared in 510(k) K003817, K003227, K043337, and K050358. These suture anchors are intended for fixation of suture(soft tissue) to bone in the shoulder, foot/ankle, hip, 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…
Read the full statement (514 words)
The Arthrex Corkscrew Family of Suture Anchors has been previously cleared in 510(k) K003817, K003227, K043337, and K050358. These suture anchors are intended for fixation of suture(soft tissue) to bone in the shoulder, foot/ankle, hip, 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 [Tendon Repair, Bunionectomy.
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, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis repair.
Pelvis: Bladder Neck Suspension for female urinary incontinence due to urethral hypermobility of intrinsic sphincter deficiency.
Hip: Capsular repair, acetabular labral repair.
The Arthrex PushLock TM, previously cleared under 510(k) K051219, is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, hip, and pelvis in the following procedures:
Shoulder: Rotator Cuff Repair, 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, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Hand/Wrist: Scapholunate Ligament Reconstruction, UInar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction
Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial collateral Ligament Reconstruction, Lateral Epicondylitis repair.
Pelvis: Bladder Neck Suspension for female urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency.
Hip: Capsular repair, acetabular labral repair.
The Arthrex TakTM Family, previously cleared under 510(k)s K971723, K000506, and K050749, is intended to be used for suture or tissue fixation in the foot, ankle, knee, hip, hand, wrist, elbow, shoulder, and in select maxillofacial applications. Specific indications are listed below and are size appropriate per patient needs:
Skull: Stabilization and fixation of oral cranio-maxillofacial skeletal bone, mandible and maxillofacial bones, Lateral Canthoplasty, Repair of Nasal Vestibular Stenosis, Brow Lift, Temporomandibular Joint (TMJ) reconstruction, soft tissue attachment to the parietal temporal ridge, frontal, zygoma, and perioorbital bones of the skull
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits, digital tendon transfers
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon transfers, Mid-foot reconstruction
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Pelvis: Bladder Neck Suspension for female urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency.
Hip: Capsular repair, acetabular labral repair.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061863 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061863: Arthrex Corkscrew Suture Anchor, Tak, and Pushlock Family.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061863
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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