# K242895: Aevumed PHANTOM Suture Anchors

- Pathway: 510(k) (Traditional)
- Applicant: Aevumed, Inc.
- Decided: Aug 6, 2025 after 317 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: 9 generations back to K961555 (1996). 13 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223878: Aevumed RAPID Suture Anchors, Aevumed, Inc. (2023) Summary page 5.

## Most influential descendants
- K253040: Aevumed FASE Suture Anchor (2025), 3 descendants of its own
- 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

## Indications for use
The Aevumed PHANTOM™ Suture Anchors are intended to be used for suture or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, shoulder, and hip. Specific indications are listed below: Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clabicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus Reconstruction, Digital Tendon Transfers, Mid-foot Reconstruction Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, lliotibial Band Tenodesis Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction, Repair/Reconstruction of Collateral Ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all Digits, Digital Tendon Transfers Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction Hip: Capsular repair, Acetabular Labral Repair

Source page: https://510kreport.com/device/K242895
Methodology: https://510kreport.com/methodology