(22 days)
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.
§ 888.3010 Bone fixation cerclage.
(a)
Identification. A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.(b)
Classification. Class II.