(77 days)
Not Found
No
The device description and intended use are purely mechanical, and there are no mentions of AI, ML, or related concepts in the provided text.
No
The device is used for mechanical fixation of soft tissues to bone during orthopedic procedures, which is a structural or supportive function, not directly therapeutic in physiological terms.
No
The device, Acufex® Tibial Anchor Screw & Spiked Washer, is described as being used for "fixation of soft tissue, such as tendon and ligaments, to bone in orthopedic procedures." This indicates a therapeutic or surgical function, not a diagnostic one.
No
The device description clearly details physical components (screw, washer) made of materials intended for implantation, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "fixation of soft tissue, such as tendon and ligaments, to bone in orthopedic procedures." This describes a surgical implant used directly on the patient's body to provide structural support.
- Device Description: The description details a physical screw and washer designed for mechanical fixation within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a patient's health status, diagnosis, or treatment.
IVD devices are used in vitro (in glass, or outside the body) to analyze samples and provide diagnostic information. This device is used in vivo (in the living body) for mechanical support.
N/A
Intended Use / Indications for Use
The Acufex® Tibial Anchor Screw & Spiked Washer is indicated for fixation of soft tissue, such as tendon and ligaments, to bone in orthopedic procedures.
Product codes
Not Found
Device Description
Acufex® Tibial Anchor Screw & Spiked Washer is a device used in soft tissue to bone fixation. The Tibial Anchor Screw is a two part screw. The outer larger part has cancellous threads, which come in direct contact with bone, and is 9 mm in diameter with a length of 20 - 30 mm. The inner part, 7 mm diameter and 20 - 25 mm length, is used to attach the Spiked Washer directly to the outer part. The spiked washer is 14 - 20 mm in diameter with spikes set at the periphery.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K871037, Synthes® Spiked Washer
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
JUL 16 1995
Image /page/0/Picture/1 description: The image shows a handwritten sequence of characters, which appears to be 'K 961649'. The characters are written in a bold, somewhat irregular style, giving them a distinct and unique appearance. The 'K' is capitalized and slightly separated from the numerical sequence. The numbers are closely spaced and have a consistent size.
510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 510(k) number is :
This summary was prepared on April 26, 1996
A.. Submitter
Smith & Nephew Endoscopy 130 Forbes Boulevard Mansfield, MA 02048
B. Company Contact
Tedd Gosian Clinical Regulatory Manager
C. Device Name
| Trade Name: | Acufex® Tibial Anchor Screw & Spiked Washer |
|---|---|
| Common Name: | Fixation Screw & Washer |
| Classification Name: | Single/Multiple component metallic bone fixation appliances |
| and accessories |
D. Predicate/Legally Marketed Devices
Concept® Soft Tissue Anchoring Implants (K871037) Synthes® Spiked Washer
E. Device Description
Acufex® Tibial Anchor Screw & Spiked Washer is a device used in soft tissue to bone fixation. The Tibial Anchor Screw is a two part screw. The outer larger part has cancellous threads, which come in direct contact with bone, and is 9 mm in diameter with a length of 20 - 30 mm. The inner part, 7 mm diameter and 20 - 25 mm length, is used to attach the Spiked Washer directly to the outer part. The spiked washer is 14 - 20 mm in diameter with spikes set at the periphery.
F. Intended Use
The Acufex® Tibial Anchor Screw & Spiked Washer is indicated for fixation of soft tissue, such as tendon and ligaments, to bone in orthopedic procedures.
1
G. Substantial Equivalence
The Acufex® Tibial Anchor Screw & Spiked Washer is intended for use for fixation of soft tissue, Such as tendon and ligaments, to bone in orthopedic procedures. The Acufex® Tibial Anchor Screw & Spiked Washer is similaris in besign, function, materials and intended use to other devices currently marketed and in commercial distribution, nately Concept® Soft Times de Soft Times de Soft Tissue Anchoring Implants (K871037) and Synthes® Spiked Washer.
Risks to health have been addressed through the specified materials, processing controls, quality assurance, and compliance through the Specified materials, processing controls, questions, que
A summary comparison of the characteristics of the Acufex® Tibial Anchor Screw & Spiked Washer and the substantially equivalent device is presented in the table below.
| | Current Product | Substantially Equivalent
Product | |
|----------------|-------------------------------------------------------------------------|----------------------------------------------|--------------------------------------------------|
| Attribute
↓ | Acufex®
Tibial Anchor Screw &
Spiked Washer | Concept® Soft Tissue
Anchoring Implants | Synthes®
Spiked Washer |
| Indication | Soft Tissue Fixation | Soft Tissue Fixation | Ligament Fixation |
| Length | Outer: 20 - 30 mm
Inner: 18 - 25 | Screw: 25 - 55 mm | |
| Diameter | Outer: 9 mm.
Inner: 7 mm
Washer: 14 - 20 mm O.D. | Screw: 6.5 mm -.
Washer: 14 to 20 mm O.D. | Washer: 13.5 mm O.D. |
| Materials | Screw: Titanium
Washer: Titanium
Reinforced Polyacetal
Polymer | Screw: Titanium
Washer: Titanium | Washer: Stainless Steel
reinforced polyacetal |
| Labeling | Sterile, Single Use Only | Sterile, Single Use Only | Sterile, Single Use Only |
Applicant
Date 4/26/96