PHANTOM Suture Anchors
by Aevumed, Inc. 510(k)
Active
510(k) K180464
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK180464 | Date31 May 2018 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- Full name
- AEVUMED PHANTOM Suture Anchors
- 510(k) Number
- FDA Product Code
- MBI
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3040
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Phantom Suture Anchors are orthopedic suture anchors designed for soft tissue fixation to bone. Constructed from polyether ether ketone (PEEK), these anchors feature a vented design and MicroThread Technology to improve pullout strength and bone integration, particularly in compromised bone quality. Available in two diameters, 3.5mm and 4.5mm, they are intended for use in procedures requiring secure attachment of soft tissues, such as rotator cuff repairs or ligament reconstructions. Their self-punching capability eliminates the need for pre-drilling, streamlining surgical workflows.
These anchors are supplied as single-use devices and are intended for use in sterile surgical environments. The 3.5mm and 4.5mm sizes cater to varying anatomical requirements, ensuring compatibility with different fixation scenarios. The device has received FDA 510(k) clearance under the Traditional review pathway, with the advisory committee classification under Orthopedics (OR). No specific MRI safety information is provided, and storage conditions are not detailed in the available data.
Other devices from Aevumed, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the primary use of the Phantom Suture Anchors?
The Phantom Suture Anchors are designed for orthopedic soft tissue fixation to bone, specifically to secure attachments in procedures like rotator cuff repairs or ligament reconstructions. Their vented PEEK construction and MicroThread Technology enhance pullout strength and bone integration, making them suitable for cases with compromised bone quality.
How are the Phantom Suture Anchors supplied, and are they reusable?
The Phantom Suture Anchors are supplied as single-use devices, intended for sterile surgical environments only. This ensures patient safety and compliance with medical device regulations, as reuse could compromise sterility and performance.
What sizes are available for the Phantom Suture Anchors, and how do they differ?
The Phantom Suture Anchors come in two diameters: 3.5mm and 4.5mm. The 3.5mm size is suited for smaller anatomical fixation needs, while the 4.5mm size provides additional strength and stability for larger or more demanding procedures, ensuring compatibility with varying surgical requirements.
Do the Phantom Suture Anchors require pre-drilling, and why is this beneficial?
No, the Phantom Suture Anchors feature a self-punching capability, eliminating the need for pre-drilling. This design streamlines the surgical workflow by reducing preparation time and potential complications, while still ensuring secure fixation to bone.
Are there any specific storage instructions provided for these anchors?
The available data does not specify detailed storage conditions for the Phantom Suture Anchors. However, as single-use sterile devices, they should be stored in a clean, dry environment away from direct sunlight or extreme temperatures to maintain their integrity until use.