Search Results

aap Biorigid Nail Femur (BNF) is intended to use in fractures of the femoral bone.

The indications are:
Types of Fractures: Simple closed fractures, Comminuted fractures, Open fractures of first, second or third degree, Crush fractures
Antegrade Indications: Femur shaft fractures, Distal femur shaft fractures, Pathological fractures, e.g. tumor osteolysis, Periprosthetic femur fracture in the middle to third part with knee replacement in situ
Retrograde Indications: Supracondylary fractures, Simultaneous nailing of femur and tibia, Distal femur fracture with osteosynthesis or hip prosthesis in situ, Periprosthetic femur fracture at knee arthroplasty
Borderline Indications: Percondylar femur fracture, Pseudarthrosis (only reamed method), Osteoporosis

Intramedullary rods are used for the stabilisation of fractures or correction of deformity of ong bones with or without interlocking screws. The connection between the nail and the interlocking screw is realised with central holes or grooves. Reamed and unreamed intramedullary nailing and for the femoral bone the antegrade and retrograde entrance are standard methods today.

agp Bioriqid Nail Femur (BNF) is the consistent development of the Biorigid Nail Tibia for the femoral bone. The BNF is a full material nail. The interlocking of the nail happens with solid Ø 5.3 mm screws through central holes and grooves.

The central holes on the nail protect against rotational forces. The grooves are designed for interlocking possibility over the whole length of the nail and a defined reduction of the rigidity because of the full material nail.

The BNF permits the execution of different implantation techniques and interlocking with only one nail. Therefore it meets the different injury manners and necessity for individual solutions.

aap Biorigid Nail Femur (BNF) incorporates

• Nail in different diameters .
• Interlocking screws in different lenghts ●
• Interlocking nut ●
• Protection cap in different lengths ●
• CondyLock ●
• Accessories, like targeting devices etc. ●

This 510(k) summary does not contain information about specific acceptance criteria or a study proving the device meets those criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices, which is a different regulatory pathway.

Therefore, I cannot populate the requested table and answer the study-related questions based on the provided document. The document primarily establishes the device's intended use, materials, and comparison to existing devices.

Here's a breakdown of why the information is missing:

• Acceptance Criteria & Device Performance: The document does not define specific performance metrics (e.g., strength, durability, biocompatibility targets) or report test results against such criteria. The "Performance Standards" section refers generally to cGMP's, ASTM requirements, and harmonized standards like ISO 9001 / EN 46001, but these are quality management and material specification standards, not specific device performance acceptance criteria.
• Study Details: Since there's no mention of specific performance testing, there's no information on:
  • Sample sizes for test sets
  • Data provenance
  • Number or qualifications of experts
  • Adjudication methods
  • MRMC comparative effectiveness studies
  • Standalone performance studies
  • Type of ground truth used
  • Training set sample size or ground truth establishment

This document is a regulatory submission for a Class II medical device (intramedullary fixation rod) seeking 510(k) clearance by demonstrating substantial equivalence. For such devices, rigorous clinical trials or extensive performance studies with explicit acceptance criteria are often not required if substantial equivalence to a legally marketed predicate device can be shown. The FDA's letter explicitly states that the device is "substantially equivalent... to legally marketed predicate devices."

What the document does provide in lieu of a performance study:

• Predicate Devices: A list of several similar intramedullary nails from other manufacturers that serve as the basis for demonstrating substantial equivalence (e.g., Howmedica Osteonics Corp. T2 Femoral Nail System, Synthes Ti Distal Femoral Nail).
• Comparison of Technological Characteristics: It states that the aap Biorigid Nail Femur (BNF) is "substantially equivalent to the predicate devices with respect to physical/technical and material characteristics." This implies that the device is expected to perform similarly to those already on the market without needing to re-prove fundamental performance through new studies.
• Material Composition: Specifies the use of Titanium Alloy (Ti 6Al 4V E.L.I. = ASTM F136), a well-established and approved material for such implants.
• Intended Use: Clearly outlines the types of fractures and anatomical locations for which the device is indicated, which aligns with the predicate devices.

Ask a specific question about this device