(46 days)
Not Found
No
The device description and intended use are for a mechanical implant (intramedullary rod system) used for fracture fixation. There is no mention of software, image processing, AI, ML, or any related performance metrics typically associated with AI/ML devices.
No.
Explanation: The device is an intramedullary rod system designed for fracture fixation and temporary stabilization, not for treating diseases, disorders, or injuries through therapeutic means. It provides mechanical support rather than a therapeutic effect.
No
Explanation: The device is described as an intramedullary rod system intended for the fixation and temporary stabilization of femoral fractures. This is a therapeutic and stabilization device, not one used for diagnosis.
No
The device description explicitly states it is a "series of intramedullary rods," which are physical hardware implants.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for the fixation and stabilization of bone fractures. This is a surgical/implantable device used directly on the patient's body.
- Device Description: The description of intramedullary rods confirms it's a physical implant for internal fixation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a physiological state, health, or disease.
IVD devices are used for diagnostic purposes by analyzing samples, not for physically treating or stabilizing anatomical structures within the body.
N/A
Intended Use / Indications for Use
The Alta® CFx IM Rod System is a series of intramedullary rods in diameters of 11mm, 13mm, and 15mm with lengths of 300mm to 480mm. These devices are intended to be used for the fixation of subtrochanteric, intertrochanteric, ipsilateral neck/shaft, and comminuted proximal femoral shaft fractures, as well as for temporary stabilization of fractures of the femoral shaft ranging from the femoral neck to the supracondylar regions of the femur. Locking screws are available for both reconstructive and interlocking indications.
Product codes
HSB
Device Description
The Alta® CFx IM Rod System is a series of intramedullary rods in diameters of 11mm, 13mm, and 15mm with lengths of 300mm to 480mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral shaft, femoral neck, supracondylar regions of the femur
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
510 (k) Summary
Proprietary Name: Alta® CFx IM Rod System
Common Name: Intramedullary Fixation Rod
Classification Name and Reference: 21 CFR 888.3020 MAR 2 2 Oct Intramedullary Fixation Rod
Proposed Regulatory Class: Class II Device Product Code: OR(87) HSB
For Information Contact: Frank Maas Manager, Regulatory Affairs Howmedica, Inc. 359 Veterans Boulevard Rutherford, N.J. 07070 Telephone: (201) 507-7875 Fax: (201) 507-6870 Date Summary Prepared: 1-31-95
The Alta® CFx IM Rod System is a series of intramedullary rods in diameters of 11mm, 13mm, and 15mm with lengths of 300mm to 480mm.
These devices are intended to be used for the fixation of subtrochanteric, intertrochanteric, ipsilateral neck/shaft, and comminuted proximal femoral shaft fractures, as well as for temporary stabilization of fractures of the femoral shaft ranging from the femoral neck to the supracondylar regions of the femur.
Locking screws are available for both reconstructive and interlocking indications.
The substantial equivalence of these rods and screws is based on an equivalence in intended use, materials, design, operational principles, and relative indications and contraindications to Howmedica's Alta® CFx IM Rod System and Alta® Femoral IM Rod System (K926232 & K850441), Howmedica's Grosse & Kempf Locking Nail (K813371A), Ace Medical's AIM Femoral System, and Zimmer's ZMS Recon Nail System.