(74 days)
Not Found
No
The summary describes a mechanical implant (screws) and does not mention any software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" fields are explicitly marked as "Not Found".
No
The device is a screw used for fixation of tendon grafts during ACL reconstruction, which is a structural component rather than a device delivering a therapeutic treatment via energy, substance, or other interventional mechanism.
No
The device description indicates it is a screw system used for fixation in surgical procedures, not for diagnosis. Its purpose is to provide early fixation of tendon grafts, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is a system of physical screws made from titanium alloy, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The DePuy Cannulated Cross Pin Screws are physical implants used within the body during surgery to fix tendon grafts. They do not analyze biological samples.
- Intended Use: The intended use is to provide fixation during a surgical procedure, not to diagnose or monitor a condition based on laboratory analysis.
Therefore, based on the provided information, the DePuy Cannulated Cross Pin Screws are a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The DePuy Cannulated Cross Pin Screws are intended to provide early fixation of autogenous or allogeneic tendon grafts in surgical procedures for anterior cruciate ligament (ACL) reconstruction.
Product codes
87 JDW
Device Description
The DePuy Cannulated Cross Pin Screw System contains cross pin screws manufactured from titanium alloy which are headless, proximally threaded with smooth shanks containing two tapers; the most distal taper being the smaller diameter tapering to a blunt tip. They are cannulated for use with their accompanying guide pins. The cross pin screws will be available in seven lengths ranging from 45mm to 75mm in 5mm increments.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
SUMMARY OF SAFETY AND EFFECTIVENESS
DEC 1 6 1996
| NAME OF FIRM: | DePuy Inc.
P.O. Box 988
700 Orthopaedic Drive
Warsaw, Indiana 46581-0988 |
|----------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| FIRM CONTACT: | Arlene Saull, RAC
Manager, Medical Device Submissions |
| TRADE NAME: | DePuy Cannulated Cross Pin Screw System |
| COMMON NAME: | Threaded fixation pin |
| CLASSIFICATION: | Smooth or threaded metallic bone fixation
fastener (21 CFR Part 888.3040) Class II |
| DEVICE PRODUCT CODE: | 87 JDW Pin, Threaded |
| SUBSTANTIALLY EQUIVALENT DEVICES:
Depuy Titanium Cross Pin Screw System | |
DePuy Cross Pin Screw System Arthrex SemiFix ACL Reconstruction System
DEVICE DESCRIPTION AND INTENDED USE:
The DePuy Cannulated Cross Pin Screw System contains cross pin screws manufactured from titanium alloy which are headless, proximally threaded with smooth shanks containing two tapers; the most distal taper being the smaller diameter tapering to a blunt tip. They are cannulated for use with their accompanying guide pins. The cross pin screws will be available in seven lengths ranging from 45mm to 75mm in 5mm increments.
The DePuy Cannulated Cross Pin Screws are intended to provide early fixation of autogenous or allogeneic tendon grafts in surgical procedures for anterior cruciate ligament (ACL) reconstruction.
BASIS OF SUBSTANTIAL EQUIVALENCE:
The DePuy Cannulated Cross Pin Screw System is substantially equivalent to the DePuy Titanium Cross Pin Screw System (K954630), the DePuy Cross Pin System (K946228), and the Arthrex SemiFix ACL Reconstruction System. The substantial equivalency is based on similar material, intended uses and design.
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