(84 days)
No
The device description and intended use focus on mechanical fixation of femoral neck fractures using pins. There is no mention of AI, ML, image processing, or any software-driven analysis or decision-making.
Yes
The device is described as a "femoral neck fracture fixation device" intended for "treatment of reducible intracapsular femoral neck fractures," which directly addresses a diseased or injured condition, making it a therapeutic device.
No
The provided text describes a device intended for the surgical fixation of femoral neck fractures, not for diagnosing medical conditions.
No
The device description clearly describes a physical implantable medical device made of stainless steel, consisting of pins with sleeves and sliding tongues. It is a hardware device for fracture fixation.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The Hansson Pin™ System is a surgical implant used to fix bone fractures. It is physically inserted into the patient's body.
- Intended Use: The intended use is for the treatment of femoral neck fractures, which is a surgical procedure, not a diagnostic test performed on a sample.
The information provided clearly describes a surgical device for internal fixation, not a device used for testing biological samples outside the body.
N/A
Intended Use / Indications for Use
The Hansson Pin™ System is intended for the treatment of reducible intracapsular femoral neck fractures, i.e. subcapital and transcervical fractures, and has been designed to minimize surgical trauma to the patient and offer secure, stable fixation.
Product codes
Not Found
Device Description
The Hansson Pin™ System is a femoral neck fracture fixation device. Each pin consists of two parts: an outer sleeve and an inner sliding tongue, and is provided pre-assembled. The outer sleeve features a proximal window, where the inner sliding tongue's hook protrudes when properly introduced. Two pins are inserted into parallel drill holes through the femoral neck and into the femoral head. Fixation of the pin in the femoral head is achieved when the inner sliding tongue is intraoperatively pushed up partially through the proximal window, and the end hook curls around into the subchondral bone. The pins measure 6.5mm in diamctcr, are available in lengths ranging from 80mm to 150mm, and are made of ASTM F-138 Stainless Steel 316 LVM.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Femoral Neck
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
FEB 2 8 1997
510(K) PREMARKET NOTIFICATION SUMMARY OF SAFETY AND EFFECTIVENESS HANSSON PINTM SYSTEM
Submission Information
Name and Address of the Sponsor of the 510(k) Submission:
Osteonics Corporation 59 Route 17 Allendale, NJ 07401-1677 201-825-4900
Contact Person:
Donna S. Wilson Regulatory Affairs Specialist
Date Summary Prepared:
Device Identification
Proprietary Name:
Common Name:
Classification Name and Reference:
Hansson Pin™ System
February 26, 1997
Femoral Neck Fracture Fixation Device
Smooth or Threaded Metallic Bone Fixation Fastener 21 CFR §888.3040
Predicate Device Identification
The Hansson Pin™ System is substantially equivalent to other legally marketed, Class II, femoral neck fracture fixation devices. The predicate devices are as follows: Howmedica Knowles Hip Pins (preamendment device), Zimmer Knowles Hip Pins (preamendment device), and Howmedica Gouffon Hip Pin System (K760454).
Device Description
The Hansson Pin™ System is a femoral neck fracture fixation device. Each pin consists of two parts: an outer sleeve and an inner sliding tongue, and is provided pre-assembled. The outer sleeve features a proximal window, where the inner sliding tongue's hook protrudes when properly introduced. Two pins are inserted into parallel drill holes through the femoral neck and into the femoral head. Fixation of the pin in the femoral head is achieved when the inner sliding tongue is intraoperatively pushed up partially through the proximal window, and the end hook curls around into the subchondral bone. The pins measure 6.5mm in diamctcr, are available in lengths ranging from 80mm to 150mm, and are made of ASTM F-138 Stainless Steel 316 LVM.
1
Intended Use
The Hansson Pin™ System is intended for the treatment of reducible intracapsular femoral neck fractures, i.e. subcapital and transcervical fractures, and has been designed to minimize surgical trauma to the patient and offer secure, stable fixation.
Statement of Technological Comparison
The subject device shares the same materials, intended use, and basic surgical preparation and insertion procedures as that of the predicate devices. Though the method of fixation for the subject device differs from that of the predicate devices, testing performed substantiates the use of the subchondral bone end hook design for fixation of the pins.