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The LactoSorb® Graft Containment System is intended to maintain the relative position of weak bony tissue such as bone grafts, bone graft substitutes, or bone fragments from comminuted fractures. The LactoSorb® Graft Containment System is also indicated for cement restriction in total joint arthroplasty procedures. Only when used in conjunction with traditional rigid fixation, the LactoSorb® Graft Containment System is intended to maintain the relative position of weak bony tissue in trauma and reconstructive orthopedic procedures involving: long bones, flat bones, short bones, irregular bones, appendicular skeleton, thorax and ribs. When used alone (without traditional rigid fixation), the LactoSorb® Graft Containment System is intended to maintain the relative position of bone grafts or bone graft substitutes in reconstructive orthopedic procedures involving: tumor resections where bone strength has not been compromised and iliac crest harvests. The device is not intended for use in the spine. The device is not intended for load bearing applications unless used in conjunction with traditional rigid fixation.

The LactoSorb® Graft Containment System, a resorbable graft containment system, is made from LactoSorb, which is composed of bioresorbable, and biocompatible polymers that have been used in surgical procedures for years. LactoSorb resorbable copolymer is derived from lactic and glycolic acids. Polylactic/polyglycolic acid copolymer degrades and resorbs in vivo by hydrolysis to lactic and glycolic acids, which are then metabolized by the body. The LactoSorb material has been found in animal and clinical studies to be biocompatible in both soft tissue and bone tissue. Preclinical and clinical studies have proven the safety and effectiveness of these devices. They have been approved to be used in trauma and reconstructive procedures in the midface and craniofacial skeleton, and for maintaining the position of bony fragments or morselized bone graft in iliac crest autograft procedures.

The LactoSorb mesh panel/sheet is provided in sizes of 25 mm x 25 mm to 100 mm x 100 mm and in other shapes and sizes as needed for particular surgical procedures. The thickness of the mesh panel/sheet ranges from 0.50 mm to 2.0 mm, according to the region to be treated, and are provided with and without macro porous holes. The borders of the mesh panel/sheet may be aligned with holes to attach suture material.

The LactoSorb mesh panel/sheet can be malleable and shaped to conform to the specific anatomy. The mesh panel/sheet can be heated to a malleable state using a hot sterile/saline water bath (K011237) or a sterile LactoSorb® Heat Pack (K941245). The mesh panel/sheet can be cut into various shapes and sizes. EBI heat contouring pen can also be used for both cutting and insitu shaping of the mesh panel/sheet. The mesh panel/sheet can be used either alone or in conjunction with fixation devices such as resorbable sutures, screws and rivets to keep the device in place. Various manual instruments are available to implant the LactoSorb® Graft Containment System.

This is a 510(k) premarket notification for a medical device (EBI LactoSorb® Graft Containment System), not a study report detailing acceptance criteria and performance data. Therefore, the requested information about acceptance criteria, study design, sample sizes, expert involvement, and ground truth cannot be extracted from the provided text.

The document primarily focuses on establishing "substantial equivalence" of the EBI LactoSorb® Graft Containment System to previously marketed predicate devices, which is a regulatory pathway for class II medical devices in the US. It does not present de novo performance data from a clinical trial or algorithm validation study.

Here's what can be inferred from the document regarding the device and its regulatory submission:

• Device: EBI LactoSorb® Graft Containment System, a resorbable graft containment system made from LactoSorb (polylactic/polyglycolic acid copolymer).
• Intended Use: To maintain the relative position of weak bony tissue (bone grafts, bone graft substitutes, or bone fragments from comminuted fractures). Also indicated for cement restriction in total joint arthroplasty procedures. Can be used with or without traditional rigid fixation depending on the application and anatomical location. Not for use in the spine or for load-bearing unless with traditional rigid fixation.
• Regulatory Pathway: 510(k) premarket notification, seeking substantial equivalence.
• Predicate Devices: Several MacroPore, Synthes, Biomet, and Lorenz devices were cited as predicates.
• Safety and Effectiveness: The document states, "Preclinical and clinical studies have proven the safety and effectiveness of these devices." However, these studies are not described in the provided text. It refers to the well-established nature of LactoSorb material and its prior use in other approved devices.
• Comparison to Predicate: The submitter asserts "There are no significant differences between the EBI LactoSorb® Graft Containment System and the following predicate devices: [...] The LactoSorb® Graft Containment System is substantially equivalent to the predicate devices in regards to intended use, material and function."

In summary, the provided text does not contain the specific details required to fill out the table and answer the questions related to acceptance criteria and a study proving device performance as it is a regulatory submission focused on substantial equivalence rather than a performance study report.

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