510(k) · Cleared
ClearedArthrex Tak 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 May 12, 2005 after a 50-day review. The FDA summary names no predicate by number. 134 later devices descend from it.
- Decided
- May 12, 2005
- Review
- 50 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 0
134 later devices descend from it, 5 citing it directly.
- This deviceK050749 Arthrex Tak FamilyArthrex, Inc. · 2005
- Descendant · cites it directly · 97 of its ownK063479 Arthrex PushlockArthrex, Inc. · 2006
- Descendant · 2 generations on · 77 of its ownK112237 Microsuture AnchorsArthrex, Inc. · 2011
- Descendant · 3 generations on · 63 of its ownK140855 Arthrex Suturetak Suture AnchorsArthrex, Inc. · 2014
- Descendant · cites it directly · 35 of its ownK070882 Stryker Peek Twinloop TacStryker Endoscopy · 2007
- Descendant · 3 generations on · 29 of its ownK140476 Arthrex Fibertak Suture AnchorArthrex, Inc. · 2014
Showing 5 of 134 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 134 · See all- K063479Arthrex PushlockArthrex, Inc. · 2006 · cites it directly97descendants
- K112237Microsuture AnchorsArthrex, Inc. · 2011 · 2 generations on77descendants
- K140855Arthrex Suturetak Suture AnchorsArthrex, Inc. · 2014 · 3 generations on63descendants
- K070882Stryker Peek Twinloop TacStryker Endoscopy · 2007 · cites it directly35descendants
- K140476Arthrex Fibertak Suture AnchorArthrex, Inc. · 2014 · 3 generations on29descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K050749 | Arthrex Tak Family | Arthrex, Inc. | 2005 | — |
| +1 | K063479 | Arthrex Pushlock | Arthrex, Inc. | 2006 | — |
| +2 | K112237 | Microsuture Anchors | Arthrex, Inc. | 2011 | — |
| +3 | K140855 | Arthrex Suturetak Suture Anchors | Arthrex, Inc. | 2014 | — |
| +1 | K070882 | Stryker Peek Twinloop Tac | Stryker Endoscopy | 2007 | — |
| +3 | K140476 | Arthrex Fibertak Suture Anchor | Arthrex, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2014 | 5 | 0 |
| 2015 | 7 | 0 |
| 2016 | 4 | 0 |
| 2017 | 7 | 0 |
| 2018 | 7 | 0 |
| 2019 | 5 | 0 |
| 2020 | 11 | 0 |
| 2021 | 5 | 0 |
| 2022 | 4 | 0 |
| 2023 | 18 | 0 |
| 2024 | 12 | 0 |
| 2025 | 19 | 0 |
| 2026 | 19 | 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?
The FDA summary names no predicate by number.
What descends from it? (134)
See all 1345 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K063479 (Arthrex, Inc., 2006) has gone furthest, with 97 descendants of its own.
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 Tak Family is intended to be used for suture or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, shoulder, and in select maxillofacial applications. Specific indications are listed below: 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…
Read the full statement (174 words)
The Arthrex Tak Family is intended to be used for suture or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, shoulder, and in select maxillofacial applications. Specific indications are listed below:
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, Brnkart 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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050749 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050749: Arthrex Tak Family.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050749
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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