510(k) · Cleared
ClearedTenodesis Screw, 5.5 MM, Model AR-1350-55
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrex, Inc. · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Jun 12, 2001 after a 69-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- Jun 12, 2001
- Review
- 69 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK011007 Tenodesis Screw, 5.5 MM, Model AR-1350-55Arthrex, Inc. · 2001
- Descendant · cites it directly · 0 of its ownK130716 Bioretec Activascrew InterferenceBioretec, Ltd. · 2013
Most influential descendants
Showing 1 of 1 · See all- K130716Bioretec Activascrew InterferenceBioretec, Ltd. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K011007 | Tenodesis Screw, 5.5 MM, Model AR-1350-55 | Arthrex, Inc. | 2001 | — |
| +1 | K130716 | Bioretec Activascrew Interference | Bioretec, Ltd. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 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 MBI? 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 MBI device
- #1 K203268 Arthrex FiberTak Suture Anchorscore 21.4 · 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? (5)
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 |
|---|---|---|---|
| * | — | Talon Anchor Snap-Pak by Mitek Products Named without a submission number | |
| * | — | RC Multisuture Bone Anchor Model 4453 by Innovasive Devices, Inc. Named without a submission number | |
| * | — | Multitak SS Buttons by Bonutti Research Named without a submission number | |
| * | — | KSEA Flipptack by Karl Storz Named without a submission number | |
| * | — | Acumed Suture Anchor by Acumed, Inc. Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K130716 | Bioretec Activascrew Interference | 2013 | 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, K130716 (Bioretec, Ltd., 2013) has gone furthest, with 0 descendants of its own.
How does its category compare?
All MBI devicesMBI Fastener, Fixation, Nondegradable, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MBI
27in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MBI
58in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MBI
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MBI
3,826in 2025
MAUDE reports naming product code MBI, 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 | 16 | 80 | 24 | 240 |
| 2008 | 10 | 69 | 6 | 338 |
| 2009 | 19 | 82 | 2 | 355 |
| 2010 | 17 | 76 | 3 | 291 |
| 2011 | 30 | 75 | 23 | 328 |
| 2012 | 24 | 94 | 6 | 371 |
| 2013 | 31 | 100 | 2 | 442 |
| 2014 | 23 | 101 | 0 | 504 |
| 2015 | 23 | 85 | 0 | 507 |
| 2016 | 17 | 94 | 0 | 795 |
| 2017 | 17 | 70 | 4 | 675 |
| 2018 | 16 | 91 | 2 | 1,072 |
| 2019 | 31 | 90 | 0 | 1,303 |
| 2020 | 35 | 83 | 1 | 1,454 |
| 2021 | 18 | 107 | 0 | 1,890 |
| 2022 | 19 | 64 | 0 | 1,591 |
| 2023 | 52 | 57 | 1 | 2,503 |
| 2024 | 22 | 30 | 1 | 3,779 |
| 2025 | 27 | 58 | 1 | 3,826 |
| 2026 | 30 | 63 | 0 | — |
What is it indicated for?
The Arthrex Tenodesis Screw, 5.5 mm for fixation of tissue grafts is intended for interference fixation of soft tissue grafts In the shoulder, elbow, wrist, and ankle, These surgeries will be performed by both open and arthroscopic means. Shoulder Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-ClavicularSeparation Repair, Deltoid Repair, Capsular Shiftor CapsulolabralReconstruction. Elbow: Biceps Tendon Reattachment…
Read the full statement (99 words)
The Arthrex Tenodesis Screw, 5.5 mm for fixation of tissue grafts is intended for interference fixation of soft tissue grafts In the shoulder, elbow, wrist, and ankle, These surgeries will be performed by both open and arthroscopic means.
Shoulder Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-ClavicularSeparation Repair, Deltoid Repair, Capsular Shiftor CapsulolabralReconstruction.
Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial CollateralLigamentReconstruction
Wrist: Scapholunate Ligament Reconstruction,Ulnar Collateral Ligament Reconstruction,Radial CollateralLigamentReconstruction
FootlAnkle: Lateral Stabilization,Medial Stabilization,Achilles Tendon Repair, Hallux VaIgus Reconstruction,Midfoot Reconstruction,Metatarsal Ligament Repair
*This system is to be used in association with adequate post-operative immobilization.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K011007 · printed Nov 3, 2026
Cite this page
510(k) Report. “K011007: Tenodesis Screw, 5.5 MM, Model AR-1350-55.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K011007
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026