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The Osse-Lign System is indicated for general orthopedic repairs. This includes such procedures as long bone fractures, bone grafting and reinforcement of bone. This system may also be used for supplementary fixation and reduction with approved bone plates, screws, pins, nails and bone grafting material.

Long Bone Fractures

• . Femur fractures
• Tibia fractures .
• l lumerus fractures l

Joint Fractures

• 트 Ankle fractures
• Knee Fractures 트
• Hip Fractures 비
• . Shoulder Fractures
• Elbow Fractures

Other bone fractures

• 발 Olecranon
• Pelvis fractures .
• Patella fractures ■
• . Acetabular fractures
• Trocanteric reattachment .
• Fixation of fractures in conjunction with I/M nailing and plating techniques
• Stabilization of cortical onlay strut graft
• Temporary reduction techniques for ORIF (Open Reduction Internal Fixation)

Metallic Internal Fixation Device

The provided text is a 510(k) summary for the "1.5 mm Osse-Lign Internal Fracture Fixation System," a metallic internal fixation device. This document focuses on the regulatory submission process and the intended use of the device.

Crucially, the document does NOT contain any information about acceptance criteria for device performance or any studies proving the device meets such criteria.

The 510(k) summary's purpose is to demonstrate substantial equivalence to a predicate device, not to provide detailed performance study results against specific acceptance criteria. The text describes the device's classification, intended use, and the FDA's decision to clear it for market based on substantial equivalence.

Therefore, I cannot provide the requested information from the given text.

To address your request, such information would typically be found in detailed study reports, clinical trial summaries, or validation documents submitted as part of the broader 510(k) submission, but these are not present in the provided excerpt.

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The Osse-Lign System is indicated for general orthopedic repairs. This includes such procedures as long bone fractures, bone grafting and reinforcement of bone. This system may also be used for supplementary fixation and reduction with approved bone plates, screws, pins, nails and bone grafting material.

Long Bone Fractures

• Femur fractures
• Tibia fractures
• Humerus fractures

Joint Fractures

• Ankle fractures
• Knee Fractures
• Hip Fractures
• Shoulder Fractures
• Elbow Fractures

Other bone fractures

• Olecranon
• Pelvis fractures
• Patella fractures
• Acetabular fractures
• Trocanteric reattachment
• Fixation of fractures in conjunction with I/M nailing and plating techniques
• Stabilization of cortical onlay strut graft
• Temporary reduction techniques for ORIF (Open Reduction Internal Fixation)

The Osse-Lign system incorporates cables that are similar in form and material to existing cable systems. However, the Osse-Lign system incorporates a unique set of tools, cable attachments and surgical approaches that permit the surgeon to achieve fracture compression and fixation either without completely encircling the bone or with a minimally invasive cerclage technique. Insertion of the Osse-Lign cables through minimally invasive surgical approaches is made possible by the unique implants and instrumentation. Finally, the in line cable fixation capability permits the use of cables through, rather than around fractures thereby increasing the possible indications for cables in fracture fixation.

Implants: The Osse-Lign system comprises implants and instruments designed to permit the insertion, tensioning, crimping and cutting of cables without the need for cerclage or large incisions. The outer diameter of the cable is 2 millimeters (2mm). The cable and all implants are manufactured from certified medical implant grade 316LVM (Low Carbon, Vacuum Melt) Stainless Steel. Cables have fittings mechanically swaged or crimped onto the ends of the cable in the factory setting using power-crimping tools.

Instruments: The Osse-Lign System instrumentation consists of the following reusable manual orthopedic instruments: Crimping Tool, Cutting Tool, Tensioning Tool, Flip Anchor Insertion Tool/Cable Passer.

The provided text is a 510(k) summary for the Osse-Lign Internal Fracture Fixation System. It focuses on establishing substantial equivalence to predicate devices and describes the device's components and indications for use.

Crucially, the document does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria.

The 510(k) submission process for this type of device (a metallic internal fixation device) primarily relies on demonstrating substantial equivalence to a legally marketed predicate device. This typically involves showing that the new device has the same intended use, similar technological characteristics (materials, design, operational principles), and similar performance characteristics as the predicate. It does not generally require the sponsor to perform new clinical studies with defined acceptance criteria for performance metrics.

Therefore, I cannot provide the information requested in your bullet points because it is not present in the provided text. The document's purpose is to satisfy regulatory requirements for market clearance based on substantial equivalence, not to detail a performance study against predefined acceptance criteria.

Ask a specific question about this device