# K180464: AEVUMED PHANTOM Suture Anchors

- Pathway: 510(k) (Traditional)
- Applicant: Aevumed, Inc.
- Decided: May 31, 2018 after 99 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
Longest line of descent: 3 generations back to K990987 (2000). 4 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061665: Arthrex 4.5 MM, 5.5 MM and 6.5 MM Corkscrew FT, Arthrex, Inc. (2006) Summary page 4.

## Most influential descendants
- K260004: Aevumed PROTEKT Suture Anchor (2026), 2 descendants of its own
- K252635: ArthroTAK Tendon Anchor Kit (2026), 1 descendant of its own
- K262809: ArthroTAK Tendon Anchor Kit (2026), 0 descendants of its own
- K254306: Aevumed FENIX Suture Anchor (2026), 0 descendants of its own

## Indications for use
The Aevumed PHANTOM™ suture anchors are intended to be used for suture and/or soft tissue fixation to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow in, but not limited to, the following procedures: • Shoulder: Rotator Cuff Repair, 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, Mid-foot Reconstruction, Metatarsal Ligament Repair. • Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair and Illiotibial Band Tenodesis. • Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction. • Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction.

Source page: https://510kreport.com/device/K180464
Methodology: https://510kreport.com/methodology