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K Number
K123745
Device Name
SP2 FEMORAL LOCKING NAIL, SP2 TIBIAL LOCKING NAIL
Manufacturer
BIOMECANICA INDUSTRIA E COMERICO DE PRODUCTOS ORTO
Date Cleared
2013-03-25

(109 days)

Product Code
HSB
Regulation Number
888.3020
Type
Traditional
Panel
OR
Reference & Predicate Devices
K112059,K003018
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The SP2 Femoral Locking Nail is indicated for long bone fracture fixation specifically femoral fixation, which may include the following:

  • Open and closed femoral fractures .
  • Pseudoarthrosis and correction osteotomy .
  • Pathologic fractures, including those with intra-articular extension .
  • Ipsilateral femur fractures .
  • Fractures proximal to a total knee arthroplasty .
  • Fractures distal to the hip ioint ●
  • Nonunions and malunions .

The SP2 Tibial Locking Nail is indicated for long bone fracture fixation specifically tibial fixation, which may include the following:

  • Open or closed shaft fractures with a very proximal and very distal . extent in which locking screw fixation can be obtained
  • Pseudarthrosis .
  • Pathologic and impending pathologic fractures .
  • Multi-fragment fractures .
  • Segmental fractures .
  • . Proximal or distal non-unions
  • . Corrective osteotomies
  • Tumor resections
  • . Comminuted fractures with or without bone loss
Device Description

The Biomecanica SP2 Femoral Locking Nail is a cylindrical, cannulated titanium alloy tube, slightly bowed to accommodate the shape of the femur. The Biomecanica SP2 Femoral Locking Nail may be inserted into the femoral canal using either a retrograde or antegrade surgical approach. The Biomecanica SP2 Femoral Locking Nail is currently available in diameters ranging from 9 to 12 mm and lengths ranging from 180 to 460 mm.

The Biomecanica SP2 Tibial Locking Nail is a temporary fixation intramedullary nail designed for fracture fixation and stabilizations of the tibia. The intramedullary nails are available in diameter ranging from 9 to 11mm and lengths ranging from 200 to 440mm. Each of the nails is secured by a series of screws that pass through holds manufactured into the proximal and distal sections of each nail.

All components of the SP2 Femoral and Tibial Locking Nails are made of titanium alloy.

AI/ML Overview

The provided document (K123745) is a 510(k) premarket notification for intramedullary nails (SP2 Femoral Locking Nail and SP2 Tibial Locking Nail). This type of regulatory submission is for medical devices, not for AI/ML-based software or diagnostic devices.

Therefore, the document does not contain any information related to:

  • Acceptance criteria for an AI/ML model's performance
  • Study design for evaluating an AI/ML model (e.g., test set, ground truth, expert review)
  • Sample sizes for training or testing AI/ML models
  • MRMC studies or human reader improvement with AI assistance
  • Standalone algorithm performance

The document is a standard medical device submission demonstrating substantial equivalence to predicate devices based on material composition, intended use, and fundamental technology, not on algorithmic performance or statistical validation of an AI model's output.

In summary, none of the requested information regarding AI/ML device acceptance criteria and study details can be extracted from this document because it pertains to a physical orthopedic implant, not an AI/ML diagnostic or assistive device.

§ 888.3020 Intramedullary fixation rod.

(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.