Acumed Suture Anchor System
FDA 510(k)Class II (US FDA 510(k))
by Acumed, LLC
Identifiers
- 510(k) Number
- K140925 FDA 510(k)
- FDA Product Code
- MBI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3040 FDA 510(k)
- Regulation Number
- 888.3040 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Acumed Suture Anchor System is a Fastener, Fixation, Nondegradable, Soft Tissue device designed for suture fixation of soft tissue to bone. It is intended for use in orthopedic procedures, including rotator cuff repair, Bankhart repair, SLAP lesion repair, biceps tenodesis, acromioclavicular separation repair, deltoid repair, and capsular shift or capsulolabral reconstruction in the shoulder, elbow, wrist, hand, foot, and ankle. Constructed from PEEK, the system provides secure attachment via double-loaded anchors with two #2 High Strength FlexBraid sutures on MO-6 Tapered Needles, available in 4.5 mm and 5.5 mm sizes.
The system is supplied sterile and intended for single-use. It is classified under FDA product code MBI and holds a 510(k) clearance under the Orthopedic Advisory Committee (OR) with a Special clearance type. Anchors are designed for use in MRI-safe environments and must be stored according to manufacturer instructions to maintain sterility and integrity. No additional regulatory approvals beyond the stated 510(k) clearance are implied.
Frequently asked questions
What orthopedic procedures is the Acumed Suture Anchor System designed for?
The Acumed Suture Anchor System is specifically designed for suture fixation of soft tissue to bone in various orthopedic procedures. These include rotator cuff repair, Bankhart repair, SLAP lesion repair, biceps tenodesis, acromioclavicular separation repair, deltoid repair, and capsular shift or capsulolabral reconstruction. The system is engineered to provide secure attachment in the shoulder, elbow, wrist, hand, foot, and ankle, ensuring stability during these critical repairs.
What materials and sizes are available for the Acumed Suture Anchor System?
The Acumed Suture Anchor System is constructed from PEEK (polyether ether ketone), a durable and biocompatible material. It is available in two sizes: 4.5 mm and 5.5 mm. Each anchor is double-loaded with two #2 High Strength FlexBraid sutures on MO-6 Tapered Needles, allowing for versatile and secure fixation options tailored to different anatomical requirements.
Is the Acumed Suture Anchor System intended for single-use or reuse?
The Acumed Suture Anchor System is explicitly designed for single-use only. This ensures sterility and reliability during surgical procedures, reducing the risk of contamination or degradation from repeated use. The system is supplied sterile, adhering to medical best practices for implantable devices.
Can the Acumed Suture Anchor System be used in MRI-safe environments?
Yes, the anchors in the Acumed Suture Anchor System are specifically designed for use in MRI-safe environments. This feature is particularly important for postoperative imaging, as it allows patients to undergo MRI scans without interference or safety concerns related to the implant materials.
How should the Acumed Suture Anchor System be stored to maintain sterility and integrity?
The Acumed Suture Anchor System must be stored according to the manufacturer’s instructions to preserve sterility and ensure the integrity of the device. Proper storage conditions prevent contamination and maintain the structural integrity of the PEEK anchors and sutures, which is critical for their performance during surgery.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PEEK Suture Anchor System - Acumed, PEEK Suture Anchor System | Acumed, K133469 FDA 510(k) - ACUMED SUTURE ANCHOR SYSTEM | Acumed, LLC
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K140925 | Class II | Active |
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Manufacturer
- Manufacturer
- Acumed, LLC
Sources (1)
- FDA 510(k) K140925 24 fields · synced Oct 1, 2026