510(k) · Cleared
ClearedArthrex Interference Screw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrex, Inc. · MAI Fastener, Fixation, Biodegradable, Soft Tissue
Cleared on Nov 29, 2006 as substantially equivalent to K052607 (Arthrex, Inc., 2005) after a 97-day review. Its family tree reaches back 1 generation to 2005. 93 later devices descend from it.
- Decided
- Nov 29, 2006
- Review
- 97 days
- Class
- Class II
- Product code
- MAI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K052607 (2005). 93 later devices descend from it, 13 citing it directly.
- Root · 1 generation backK052607 Arthrex Interference Screw-Rounded Head Screws, Full Threaded…Arthrex, Inc. · 2005
- This deviceK062466 Arthrex Interference ScrewArthrex, Inc. · 2006
- Descendant · cites it directly · 47 of its ownK071176 Modification to: Arthrex Interference ScrewArthrex, Inc. · 2007
- 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
- Descendant · 4 generations on · 21 of its ownK191226 Arthrex SwiveLock Suture AnchorArthrex, Inc. · 2019
Showing 5 of 93 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 93 · See all- K071176Modification to: Arthrex Interference ScrewArthrex, Inc. · 2007 · cites it directly47descendants
- K151342Arthrex SwiveLock AnchorsArthrex, Inc. · 2016 · 2 generations on38descendants
- K171141Arthrex SwiveLock AnchorsArthrex, Inc. · 2017 · 3 generations on29descendants
- K180768Arthrex SwiveLock AnchorsArthrex, Inc. · 2018 · 3 generations on28descendants
- K191226Arthrex SwiveLock Suture AnchorArthrex, Inc. · 2019 · 4 generations on21descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K052607 | Arthrex Interference Screw-Rounded Head Screws, Full Threaded Screws, Sheathed… | Arthrex, Inc. | 2005 | — |
| 0 (this device) | K062466 | Arthrex Interference Screw | Arthrex, Inc. | 2006 | — |
| +1 | K071176 | Modification to: Arthrex Interference Screw | Arthrex, Inc. | 2007 | — |
| +2 | K151342 | Arthrex SwiveLock Anchors | Arthrex, Inc. | 2016 | — |
| +3 | K171141 | Arthrex SwiveLock Anchors | Arthrex, Inc. | 2017 | — |
| +3 | K180768 | Arthrex SwiveLock Anchors | Arthrex, Inc. | 2018 | — |
| +4 | K191226 | Arthrex SwiveLock Suture Anchor | Arthrex, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 0 |
| 2009 | 5 | 0 |
| 2010 | 2 | 0 |
| 2011 | 4 | 0 |
| 2012 | 1 | 0 |
| 2013 | 4 | 0 |
| 2014 | 5 | 0 |
| 2015 | 4 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 6 | 0 |
| 2019 | 5 | 0 |
| 2020 | 8 | 0 |
| 2021 | 5 | 0 |
| 2022 | 5 | 0 |
| 2023 | 11 | 0 |
| 2024 | 4 | 0 |
| 2025 | 10 | 0 |
| 2026 | 8 | 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 MAI? 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 MAI device
- #1 K203495 Arthrex SwiveLock Anchorscore 35.2 · 11 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 |
|---|---|---|---|
| * | K052607 | Arthrex Interference Screw-Rounded Head Screws, Full Threaded Screws, Sheathed…Summary page 1…MBI, 21 CFR 888.3040 Classification Name: Fixation, Fastener, bone Predicate Device: Arthrex Interference Screw, K052607 Device Description and Intended Use: The Arthrex Interference Screws are intended to be used for fixation of tissue including li… | 2005 |
What descends from it? (93)
See all 9313 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071176 | Modification to: Arthrex Interference Screw | 2007 | 47 |
| K083635 | Smith & Nephew Biosure PK Interference Screw | 2009 | 21 |
| K083226 | Smith & Nephew Peek Interference Screw | 2009 | 9 |
| K083619 | Parcus Tintanium Interference Screw, Models: 10001-10012, 10014-10016, 10018-10020 | 2009 | 7 |
| K130217 | Orthopediatrics Acl Reconstructive System | 2013 | 4 |
| K101808 | Shapeloc-CL (Cruciate Ligament) Soft Tissie Fastner, Shapeloc-ST (Tenodesis) Soft Tissue… | 2010 | 4 |
| K180573 | Responsive Arthroscopy Interference Screw System | 2018 | 2 |
| K133606 | N8TIVE Acl Anatomic Reconstruction System, N8TIVE Acl Femoral Implant, N8TIVE Acl Tibial… | 2014 | 2 |
| K111471 | Exoshape (TM) Interference Fixation Device Model 1100-00-XXXX (Varies by Size) | 2011 | 1 |
| K071464 | Inion Hexalon Biodegradable Acl/PCL Screw | 2007 | 1 |
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?
How does its category compare?
All MAI devicesMAI Fastener, Fixation, Biodegradable, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MAI
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MAI
54in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MAI
40in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MAI
2,148in 2025
MAUDE reports naming product code MAI, 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 | 4 | 100 | 0 | 272 |
| 2008 | 3 | 83 | 0 | 172 |
| 2009 | 9 | 74 | 0 | 88 |
| 2010 | 4 | 122 | 0 | 89 |
| 2011 | 9 | 90 | 5 | 129 |
| 2012 | 6 | 56 | 10 | 171 |
| 2013 | 6 | 135 | 0 | 166 |
| 2014 | 4 | 86 | 0 | 149 |
| 2015 | 5 | 95 | 0 | 182 |
| 2016 | 3 | 191 | 0 | 301 |
| 2017 | 9 | 113 | 0 | 478 |
| 2018 | 13 | 108 | 0 | 1,590 |
| 2019 | 9 | 41 | 2 | 1,248 |
| 2020 | 9 | 78 | 40 | 957 |
| 2021 | 8 | 115 | 0 | 1,267 |
| 2022 | 6 | 136 | 0 | 1,425 |
| 2023 | 8 | 34 | 0 | 1,718 |
| 2024 | 7 | 53 | 0 | 2,300 |
| 2025 | 8 | 54 | 0 | 2,148 |
| 2026 | 5 | 69 | 1 | — |
What is it indicated for?
The Arthrex Interference Screws are intended to be used for fixation of tissue including ligament or tendon to bone and bone tendon bone. Interference fixation with PEEK, Titanium, or Bioabsorbable Polymer Interference Screws is appropriate for surgeries of the knee, shoulder, elbow, ankle, foot, and hand/wrist where the sizes offered are patient appropriate. Specifically; Shoulder Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps…
Read the full statement (168 words)
The Arthrex Interference Screws are intended to be used for fixation of tissue including ligament or tendon to bone and bone tendon bone. Interference fixation with PEEK, Titanium, or Bioabsorbable Polymer Interference Screws is appropriate for surgeries of the knee, shoulder, elbow, ankle, foot, and hand/wrist where the sizes offered are patient appropriate. 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, Ulnar 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/K062466 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062466: Arthrex Interference Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062466
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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