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The Interpore Inducer Bone Graft Delivery Syringe is indicated for the delivery of allograft, autograft or synthetic bone graft material to an orthopaedic surgical site. In addition, it is designed to facilitate pre-mixing of a bone graft material with I.V. fluids, blood, plasma, bone marrow or other specific blood component(s) as deemed necessary by the clinical use requirements.

The Interpore Inducer has a volume of approximately 15 cc.

The INTERPORE Inducer Bone Graft Delivery Syringe is a piston syringe intended for use to deliver allograft, autograft or synthetic bone graft materials to an orthopaedic surgical site. In addition, it is designed to facilitate pre-mixing of bone graft materials with I.V. fluids, blood, plasma, bone marrow or other specific blood component(s) as deemed necessary by the clinical use requirements. The Interpore Inducer has a volume of approximately 15cc.

The Interpore Inducer is a specially designed syringe specifically intended to deliver bone graft materials to a surgical site. It is supplied sterile in double aseptic transfer packaging.

The Interpore Inducer consists of a syringe barrel, syringe top cap, piston and plunger. The distal end of the syringe has a removable top cap which must be aseptically removed in order to load the bone graft material into the syringe. After loading the syringe, the top cap may be reattached to the syringe to constrain the contents of the syringe or to minimize potential contamination of the syringe contents. In addition, the top cap has a male luer-lok connector which may be attached to any standard female luer adapter for fluid transfer.

The piston of the syringe is designed to eject fluids or blood components and bone graft materials into the operative site. It is also designed to be the attachment point for the syringe plunger. The proximal end of the piston also has a female luer-lok connector which may be connected to any standard male luer adapter for delivery of fluids or blood components into the syringe.

The syringe plunger is provided separately and is attached to the proximal end of the syringe piston immediately prior to bone graft expulsion from the syringe into the surgical site.

This 510(k) premarket notification for the Interpore Inducer Bone Graft Delivery Syringe does not contain a study that proves the device meets acceptance criteria. Instead, the document establishes substantial equivalence to existing predicate devices based on product design, material of construction, and function as a piston syringe.

Therefore, I cannot provide the requested information in a table or as answers to points 1-9 because no such study is described or referenced in the provided text.

The core of the submission (pages 1-3) describes the device, its intended use, and comparison to predicate devices, stating: "The product design, material of construction, and function as a piston syringe is substantially equivalent to the FDA cleared predicate devices." This implies that the device is considered safe and effective because it is fundamentally similar to devices already on the market that have established their safety and effectiveness.

The FDA's response (pages 4-5) confirms the finding of substantial equivalence, which allows the device to be marketed without requiring new clinical trials to prove its own efficacy and safety, as its equivalence to already approved devices is sufficient.

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