(117 days)
Not Found
Not Found
No
The description details a mechanical plate and screw system for fracture fixation and does not mention any software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as a "place and screw system intended to treat fractures of various long bones," indicating its use in treating a medical condition.
No
The device, Synthes ALPS, is described as a "place and screw system intended to treat fractures," indicating it is a therapeutic device used for "stable fixation" of bones, not for diagnosing conditions.
No
The device description clearly states it is a "place and screw system" and describes physical components like plates and screws, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to treat fractures of various long bones. This is a surgical intervention, not a diagnostic test performed on samples from the body.
- Device Description: The device is a plate and screw system designed for internal fixation of bones. This is a medical device used in vivo (within the body) for treatment.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze such specimens.
Therefore, based on the provided information, the Synthes ALPS is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Synthes ALPS is a place and screw system intended to treat fractures of various long bones, including the radius, ulna, humerus, tibia, fibula and femur.
Product codes
Not Found
Device Description
The ALPS urilizes a locking feature that secures the screw to the plate, enabling stable fixation to be achieved via unicortical or bicortical fixation. The plates are available with and without an anatomically contoured head, in a variety of sizes. The head of the screw has a round cross section with a conical underside to fit into the plate. The underside has a tapered thread to match the holes in the plate. The screws are available in thread diameters from 3 mm, in a variery of lengths.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
various long bones, including the radius, ulna, humerus, tibia, fibula and 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
Based on the results of confidential testing, it is our opinion that the ALPS is substantially equivalent to the devices with which it is being compared.
Key Metrics
Not Found
Predicate Device(s)
Synthes PC-Fix, Condylar Plate 95°, Condylar Buttress Plate, 4.5 mm Cortex Screws, and 6.5 mm Cancellous Screws
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
AUG - 7 1996
K961413
Summary of Safety and Effectiveness Information
Synthes (USA) 1690 Russell Road Paoli, PA 19301
(610) 647-9700 Contact: Angela Silvestri July 1996
Device: Synthes Anatomical Locking Plate System (ALPS) compared to Synthes PC-Fix, Condylar Plate 95°, Condylar Buttress Plate, 4.5 mm Cortex Screws, and 6.5 mm Cancellous Screws
Synthes ALPS is a place and screw system intended to treat fractures of various long bones, including the radius, ulna, humerus, tibia, fibula and femur. The ALPS urilizes a locking feature that secures the screw to the plate, enabling stable fixation to be achieved via unicortical or bicortical fixation. The plates are available with and without an anatomically contoured head, in a variety of sizes. The head of the screw has a round cross section with a conical underside to fit into the plate. The underside has a tapered thread to match the holes in the plate. The screws are available in thread diameters from 3 mm, in a variery of lengths.
It is anticipated that the ALPS will be used as follows:
- a) The place is percutaneously inserted through a stab incision at either the distal or proximal end of the bone.
- b) The fracture is reduced and temporary fixation may be applied.
- c) The Insertion Guide is first attached to a screw hole at the head of the plate (the last screw hole on either end of the shaft plate) using the Connecting Screw.
- d) The distal end of the plate is then inserted into the incision first. This end is tapered and rounded to gently lift and separate tissue.
- e) The plate is manipulated using the insertion handle.
- f) Once the plate is in position the ALPS screw can be inserted.
- g) The Insertion Sleeve and Trocar are placed through one of the aiming boles. The trocar perforates the skin and facilitates the sleeve positioning to the corresponding screw hole in the plate. The trocar is removed from the sleeve.
- h) The screwdriver, with a screw attached, is then inserted through the sleeve.
- The screw is inserted into the bone securing the plate. 1)
- After tightening the screw to the plate, the function of the implant and fixation will not be ]) jeopardized if the plate is not flush against the bone.
- k) After the screws are in place the Insertion Guide is removed.
-
- An additional screw can be placed in the screw hole that secured the Insertion Guide if necessary.
Synthes Anatomical Locking Plate System will be provided both sterile and non-sterile. The sterile device will be sterilized by gamma radiation. Of course, non sterile devices must be sterilized prior to use; moist heat sterilization is recommended.
Based on the results of confidential testing, it is our opinion that the ALPS is substantially equivalent to the devices with which it is being compared.