# K011007: Tenodesis Screw, 5.5 MM, Model AR-1350-55

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Jun 12, 2001 after 69 days
- Product code: MBI (Fastener, Fixation, Nondegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Talon Anchor Snap-Pak by Mitek Products: named in the summary without a submission number
- (no number) RC Multisuture Bone Anchor Model 4453 by Innovasive Devices, Inc.: named in the summary without a submission number
- (no number) Multitak SS Buttons by Bonutti Research: named in the summary without a submission number
- (no number) KSEA Flipptack by Karl Storz: named in the summary without a submission number
- (no number) Acumed Suture Anchor by Acumed, Inc.: named in the summary without a submission number

## Most influential descendants
- K130716: Bioretec Activascrew Interference (2013), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K011007
Methodology: https://510kreport.com/methodology