# K071176: Modification to: Arthrex Interference Screw

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Aug 3, 2007 after 98 days
- Product code: MAI (Fastener, Fixation, Biodegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K971358 (1997). 19 ancestors in all.
47 later devices descend from it; 3 cite it directly.
0 of 67 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062466: Arthrex Interference Screw, Arthrex, Inc. (2006) Summary page 1.
- K060830: Milagro Interference Screw, Depuy Mitek, A Johnson & Johnson Company (2006) Summary page 1.
- K032717: Biocryl Rapide Interference Screw, Mitek Worldwide (2004) Summary page 1.
- K051310: PLC Screw, Smith & Nephew, Inc. (2005) Summary page 1.
- K002274: Smith & Nephew Suture Hapla Interference Screw, Smith & Nephew, Inc. (2001) Summary page 1.

## Most influential descendants
- K151342: Arthrex SwiveLock Anchors (2016), 38 descendants of its own
- K171141: Arthrex SwiveLock Anchors (2017), 29 descendants of its own
- K180768: Arthrex SwiveLock Anchors (2018), 28 descendants of its own
- K191226: Arthrex SwiveLock Suture Anchor (2019), 21 descendants of its own
- K203495: Arthrex SwiveLock Anchor (2021), 13 descendants of its own

## Indications for use
The Arthrex Biocomposite Interference Screws are intended to be used for fixation of tissue, including ligament or tendon to bone, or a bone/tendon to bone. Interference fixation 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, Posterior 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

Source page: https://510kreport.com/device/K071176
Methodology: https://510kreport.com/methodology