510(k) · Cleared
ClearedArthrex Tenodesis Screw 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 Nov 4, 2004 after a 168-day review. The FDA summary names no predicate by number. 247 later devices descend from it.
- Decided
- Nov 4, 2004
- Review
- 168 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 0
247 later devices descend from it, 6 citing it directly.
- This deviceK041356 Arthrex Tenodesis Screw FamilyArthrex, Inc. · 2004
- Descendant · cites it directly · 217 of its ownK052776 Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel…Arthrex, Inc. · 2005
- Descendant · 2 generations on · 91 of its ownK112437 Arthrex Fracture SystemArthrex, Inc. · 2011
- Descendant · 3 generations on · 71 of its ownK123241 Arthrex Fracture PlatesArthrex, Inc. · 2013
- Descendant · 2 generations on · 59 of its ownK082095 Ultraslide Acromioclavicular and Syndesmotic Repair DeviceSmith & Nephew Endoscopy, Inc. · 2008
- Descendant · 2 generations on · 49 of its ownK112111 Acu-Sinch Repair System and Acumed Suture AnchorAcumed, LLC · 2011
Showing 5 of 247 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 247 · See all- K052776Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models AR-2257…Arthrex, Inc. · 2005 · cites it directly217descendants
- K112437Arthrex Fracture SystemArthrex, Inc. · 2011 · 2 generations on91descendants
- K123241Arthrex Fracture PlatesArthrex, Inc. · 2013 · 3 generations on71descendants
- K082095Ultraslide Acromioclavicular and Syndesmotic Repair DeviceSmith & Nephew Endoscopy, Inc. · 2008 · 2 generations on59descendants
- K112111Acu-Sinch Repair System and Acumed Suture AnchorAcumed, LLC · 2011 · 2 generations on49descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K041356 | Arthrex Tenodesis Screw Family | Arthrex, Inc. | 2004 | — |
| +1 | K052776 | Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models… | Arthrex, Inc. | 2005 | — |
| +2 | K112437 | Arthrex Fracture System | Arthrex, Inc. | 2011 | — |
| +3 | K123241 | Arthrex Fracture Plates | Arthrex, Inc. | 2013 | — |
| +2 | K082095 | Ultraslide Acromioclavicular and Syndesmotic Repair Device | Smith & Nephew Endoscopy, Inc. | 2008 | — |
| +2 | K112111 | Acu-Sinch Repair System and Acumed Suture Anchor | Acumed, LLC | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 3 | 0 |
| 2009 | 3 | 0 |
| 2011 | 8 | 0 |
| 2012 | 3 | 0 |
| 2013 | 10 | 0 |
| 2014 | 16 | 0 |
| 2015 | 9 | 0 |
| 2016 | 4 | 0 |
| 2017 | 12 | 0 |
| 2018 | 13 | 0 |
| 2019 | 21 | 0 |
| 2020 | 18 | 0 |
| 2021 | 15 | 0 |
| 2022 | 19 | 0 |
| 2023 | 18 | 0 |
| 2024 | 27 | 0 |
| 2025 | 20 | 0 |
| 2026 | 23 | 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? (247)
See all 2476 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K052776 | Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models AR-2257… | 2005 | 217 |
| K103831 | Depuy Mitek Milagro Interference Screw Model 231803, 231804, 231807, 231809 | 2011 | 18 |
| K133036 | Apollo Suture Anchor System and Titan Screws | 2014 | 7 |
| K071464 | Inion Hexalon Biodegradable Acl/PCL Screw | 2007 | 1 |
| K130716 | Bioretec Activascrew Interference | 2013 | 0 |
| K122869 | Milagro Interference Screws | 2012 | 0 |
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, K052776 (Arthrex, Inc., 2005) has gone furthest, with 217 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 Tenodesis Family of Screws, made up of titanium or polylactide (PLLA), are intended to provide soft tissue reattachment, i.e., fixation of ligament and tendon graft tissue in surgeries of the shoulder, elbow, knee, 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.…
Read the full statement (132 words)
The Arthrex Tenodesis Family of Screws, made up of titanium or polylactide (PLLA), are intended to provide soft tissue reattachment, i.e., fixation of ligament and tendon graft tissue in surgeries of the shoulder, elbow, knee, 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, Mid-foot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon reconstruction.
Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, and lilotibial Band Tenodesis.
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction.
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Lateral Epicondylitis repair,
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041356 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041356: Arthrex Tenodesis Screw Family.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041356
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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