← Back to catalogue

Short and Long Soft Tissue Attachment

FDA 510(k)

Class II (US FDA 510(k))

510(k) K022079

by Biomet, Inc.

Identifiers

510(k) Number
K022079 FDA 510(k)
FDA Product Code
KWT FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3650 FDA 510(k)
Regulation Number
888.3650 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Short and Long Soft Tissue Attachment is a soft tissue fixation device designed to stabilize and attach soft tissues to orthopedic implants. It features two variants—short and long sleeves—each engineered to secure soft tissue with adjustable tension. The short sleeve includes four suture holes perpendicular to its axis, while the long sleeve incorporates five perpendicular holes and four additional holes, enhancing versatility for surgical applications. This device is intended for use in orthopedic procedures requiring secure soft tissue attachment to implants.

The device is supplied as a reusable medical instrument and is regulated under FDA 510(k) clearance (K022079) with a traditional review process. It is intended for use in orthopedic settings, where sterility and precision are critical. The short and long sleeves are designed for compatibility with specific implant systems, such as the Biomet Mosaic™ Humeral System, and are stored in a sterile or clean condition prior to surgical use. No additional regulatory approvals beyond the FDA 510(k) clearance are stated in the specifications.

Frequently asked questions

What is the Short and Long Soft Tissue Attachment used for?

This device is designed to stabilize and attach soft tissues to orthopedic implants during surgical procedures. The adjustable tension feature ensures secure fixation, which is critical in orthopedic applications where stability is essential. The short sleeve (with four suture holes) and long sleeve (with five perpendicular and four additional holes) provide flexibility to accommodate different surgical needs and implant systems, such as the Biomet Mosaic™ Humeral System.

How is the Short and Long Soft Tissue Attachment supplied and prepared for use?

The device is supplied as a reusable medical instrument. Prior to surgical use, it must be maintained in a sterile or clean condition to meet orthopedic standards. Since it is reusable, proper cleaning and sterilization protocols must be followed between uses to ensure safety and efficacy. The device is not intended for single-use, so its preparation involves adherence to sterile handling procedures specific to reusable orthopedic instruments.

Is the Short and Long Soft Tissue Attachment single-use or reusable?

This device is explicitly designed as a reusable medical instrument. Reusability is supported by its durable construction and the requirement for proper cleaning and sterilization between uses. This approach aligns with orthopedic practice standards where reusable tools are commonly utilized when safety and sterility protocols are rigorously followed.

What are the key differences between the short and long sleeves?

The short sleeve features four suture holes perpendicular to its axis, providing a compact design for targeted soft tissue attachment. In contrast, the long sleeve includes five perpendicular suture holes plus four additional holes, offering enhanced versatility for more complex or larger tissue fixation requirements. This design distinction allows surgeons to select the appropriate sleeve based on the specific surgical needs and implant compatibility.

How should the Short and Long Soft Tissue Attachment be stored before use?

The device should be stored in a sterile or clean condition prior to surgical use to prevent contamination. Since it is reusable, storage should follow manufacturer guidelines for orthopedic instruments, typically in a dedicated, protected environment that maintains sterility until the time of use. Proper storage ensures the device remains ready for surgical procedures while minimizing the risk of infection or degradation.

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: K022079 FDA 510 (k) - SHORT AND LONG SOFT TISSUE ATTACHMENT, SHORT AND LONG SOFT TISSUE ATTACHMENT - Innolitics, PDF K022079 - Short and Long Soft Tissue Attachment, SHORT AND LONG SOFT TISSUE ATTACHMENT 510(k) K022079 - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Biomet, Inc.

Sources (1)

  • FDA 510(k) K022079 24 fields · synced Oct 1, 2026