510(k) · Cleared
ClearedArthrex Tenodesis 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 Sep 27, 2005 after a 91-day review. The FDA summary names no predicate by number. 137 later devices descend from it.
- Decided
- Sep 27, 2005
- Review
- 91 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 0
137 later devices descend from it, 13 citing it directly.
- This deviceK051726 Arthrex Tenodesis FamilyArthrex, Inc. · 2005
- Descendant · cites it directly · 103 of its ownK101823 Arthrex Swivelock AnchorsArthrex, Inc. · 2011 · Recalled
- Descendant · 2 generations on · 40 of its ownK110545 Smith & Nephew Next Generation Fully Threaded Peek Suture Anchor…Smith & Nephew, Inc. · 2011
- Descendant · 2 generations on · 38 of its ownK151342 Arthrex SwiveLock AnchorsArthrex, Inc. · 2016
- Descendant · 3 generations on · 29 of its ownK171141 Arthrex SwiveLock AnchorsArthrex, Inc. · 2017
- Descendant · 3 generations on · 28 of its ownK180768 Arthrex SwiveLock AnchorsArthrex, Inc. · 2018
Showing 5 of 137 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 137 · See all- K101823Arthrex Swivelock AnchorsArthrex, Inc. · 2011 · cites it directly103descendants
- K110545Smith & Nephew Next Generation Fully Threaded Peek Suture Anchor (Ngftsa PK)Smith & Nephew, Inc. · 2011 · 2 generations on40descendants
- K151342Arthrex SwiveLock AnchorsArthrex, Inc. · 2016 · 2 generations on38descendants
- K171141Arthrex SwiveLock AnchorsArthrex, Inc. · 2017 · 3 generations on29descendants
- K180768Arthrex SwiveLock AnchorsArthrex, Inc. · 2018 · 3 generations on28descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K051726 | Arthrex Tenodesis Family | Arthrex, Inc. | 2005 | — |
| +1 | K101823 | Arthrex Swivelock Anchors | Arthrex, Inc. | 2011 | 6 |
| +2 | K110545 | Smith & Nephew Next Generation Fully Threaded Peek Suture Anchor (Ngftsa PK) | Smith & Nephew, Inc. | 2011 | — |
| +2 | K151342 | Arthrex SwiveLock Anchors | Arthrex, Inc. | 2016 | — |
| +3 | K171141 | Arthrex SwiveLock Anchors | Arthrex, Inc. | 2017 | — |
| +3 | K180768 | Arthrex SwiveLock Anchors | Arthrex, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 6 | 0 |
| 2012 | 3 | 0 |
| 2013 | 8 | 0 |
| 2014 | 3 | 0 |
| 2015 | 4 | 0 |
| 2016 | 2 | 0 |
| 2017 | 5 | 0 |
| 2018 | 8 | 0 |
| 2019 | 9 | 0 |
| 2020 | 8 | 0 |
| 2021 | 6 | 0 |
| 2022 | 9 | 0 |
| 2023 | 18 | 0 |
| 2024 | 14 | 0 |
| 2025 | 18 | 0 |
| 2026 | 16 | 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? (137)
See all 13713 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101823 | Arthrex Swivelock Anchors | 2011 | 103 |
| K103831 | Depuy Mitek Milagro Interference Screw Model 231803, 231804, 231807, 231809 | 2011 | 18 |
| K200725 | Citregen Tendon Interference Screw and Citrelock | 2020 | 4 |
| K183690 | Tenodesis Screw System | 2019 | 3 |
| K123350 | Eclipse Soft Tissue Fastener | 2013 | 2 |
| K252664 | GMReis Suture Anchors | 2025 | 1 |
| K181513 | Arthrex PushLock Tenodesis Anchor | 2018 | 1 |
| K120589 | Milagro Interference Screws | 2012 | 1 |
| K151701 | Tenodesis screw system | 2016 | 0 |
| K141290 | Helical Ridge Peek Interference Screw | 2014 | 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, K101823 (Arthrex, Inc., 2011) has gone furthest, with 103 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 Screws are constructed of various polymers and metals and 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…
Read the full statement (151 words)
The Arthrex Tenodesis Screws are constructed of various polymers and metals and 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, Midfoot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon reconstruction, tendon transfers in the foot and ankle
Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis
Elbow: Biceps Tendon Reattachment, UInar or Radial Collateral Ligament Reconstruction
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty), Carpal Ligament Reconstructions and repairs, tendon transfer in the hand/ wrist
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051726 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051726: Arthrex Tenodesis Family.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051726
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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