(124 days)
Not Found
Alphatec Large Cannulated Screw System, Richards Universal and 8.0 mm Cannulated Screw, Ace Screw, Howmedica Asnis 2 Guided Screw System
No
The device description and other sections do not mention AI or ML, and the device appears to be a purely mechanical implant.
No
The device, "EZ-Fix™ Cannulated Screws," is used to stabilize fractures of the femur, tibia, pelvis, acetabulum, shoulder, and elbow. This is a structural support function, not a therapeutic treatment of disease or condition by restoring health or alleviating suffering.
No
Explanation: The device, EZ-Fix™ Cannulated Screws, is a surgical implant designed to stabilize bone fractures. Its intended use is therapeutic (fixation of fractures), not diagnostic (identifying or characterizing a medical condition).
No
The device description clearly states it is a physical screw fabricated from titanium alloy, which is a hardware component, not software.
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 to stabilize bone fractures within the body. This is a surgical implant, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description details the physical characteristics of a surgical screw made from titanium alloy, designed for insertion into bone.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process related to in vitro testing.
Therefore, the EZ-Fix™ Cannulated Screws are a surgical device, not an IVD.
N/A
Intended Use / Indications for Use
The EZ-Fix™ Cannulated Screws are indicated for single use to stabilize intracapsular, certain cervical and subcapital fractures of the femur; fractures of the distal femur and proximal tible: pelvis and acetabular fractures and certain fractures of the shoulder and elbow. They are contraindicated for attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, lumbar spine.
Product codes
Not Found
Device Description
The EZ-Fix™ Cannulated Screws are indicated for single use to stabilize intracapsular, certain cervical and subcapital fractures of the femur; fractures of the distal femur and proximal tible: pelvis and acetabular fractures and certain fractures of the shoulder and elbow. They are contraindicated for attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, lumbar spine.
The EZ-Fix™ Cannulated Screws are fabricated from titanium allov (Ti-BAL-4V ELI). They are tested per ASTM standards and have a thread diameter and length of 7.3 mm and 20 mm respectively and a shaft diameter of 5.3 mm. They accept a 3.2 mm guide pin through the 3.45 mm cannulation. They are self reaming and tapping and have reverse cutting flutes.
The EZ-Fix™ Cannulated Screws are available in 35 mm to 125 mm lengths are supplied non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Femur (intracapsular, certain cervical and subcapital fractures, distal femur), proximal tibia, pelvis, acetabulum, shoulder, elbow. Contraindicated for posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
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)
Testing: Awaiting from Orthopaedics Biomechanics Laboratory.
Equivalence: These test values are identical to those obtained on the referenced equivalent.
Conclusion: Based on the materials, intended uses, design, testing, and manufacturing, the EZ Fix™ Cannulated Screw System is equivalent to the referenced legally marketed comparison devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Alphatec Large Cannulated Screw System, Richards Universal and 8.0 mm Cannulated Screw, Ace Screw, Howmedica Asnis 2 Guided Screw System
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
NOV 13 1996
Section 510(k) Premarket Notification
Summary of Safety and Effectiveness Information
Regulatory Authority: Safe Medical Devices Act of 1990, 21 CFR 807.92
| Device Trade Name: | EZ-Fix™ Cannulated Screw System |
|---|---|
| -------------------- | --------------------------------- |
Common Name: Large Cannulated Screws
Registration Number: 888.3040
Classification Name: Screw, Fixation, Bone
Establishment Name & Registration Number:
| Name: | Biodynamic Technologies, Inc.
East Newport Center Drive
Deerfield Beach, Florida 33442
(305) 421-3166 (305) 570-6368 FAX |
| ------- | ----------------------------------------------------------------------------------------------------------------------------------- |
|---|
. Number: 1035157
Classification:
Device Class: Class II
Classification Panel: Orthopedic
Contact Person:
Danny Hodgeman Biodynamic Technologies, Inc. East Newport Center Drive Deerfield Beach, Florida 33442 (305) 421-3166 (305) 570-6368 FAX
Special Controls:
Not applicable to this device.
Device Description:
The EZ-Fix™ Cannulated Screws are indicated for single use to stabilize intracapsular, certain cervical and subcapital fractures of the femur; fractures of the distal femur and
1
proximal tible: pelvis and acetabular fractures and certain fractures of the shoulder and elbow. They are contraindicated for attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, lumbar spine.
The EZ-Fix™ Cannulated Screws are fabricated from titanium allov (Ti-BAL-4V ELI). They are tested per ASTM standards and have a thread diameter and length of 7.3 mm and 20 mm respectively and a shaft diameter of 5.3 mm. They accept a 3.2 mm guide pin through the 3.45 mm cannulation. They are self reaming and tapping and have reverse cutting flutes.
The EZ-Fix™ Cannulated Screws are available in 35 mm to 125 mm lengths are supplied non-sterile.
Substantially Equivalent Devices:
- Alphatec Large Cannulated Screw System 1. See Appendix III for promotional materials for the companison device.
-
- Richards Universal and 8.0 mm Cannulated Screw See Appendix III for promotional materials for the comparison device.
- છે. Ace Screw
See Appendix III for promotional materials for the comparison device.
-
- Howmedica Asnis 2 Guided Screw System See Appendix III for promotional materials for the comparison device.
Comparison to Predicate Device:
The EZ-Fix™ Cannulated Screws are substantially equivalent to the Alphatec, Ace, Richards and Howmedica large cannulated screws in that they are bone fixation screw devices Indicated for single use to stabilize intracapsular, certain cervical and subcapital fractures of the femur: fractures of the distal femur and proximal tibia: pelvis and acetabular fractures and certain fractures of the shoulder and elbow. They are contraindicated for attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine. They are fabricated and tested per ASTM standards, they accept a 3.2 mm gulde pin, they are self tapping, and they are supplied non-sterile. Like Alphatec, Richards and Howmedica, they have reverse cutting firstes.
The EZ-Fix™ Cannulated Screws are substantially equivalent to the Alphatec and Ace screws in that they are made from titanium alloy (Ti-6Al-4V ELI).
The EZ-FIX™ Cannulated Screws are substantially equivalent to the Alphatec. Ace and Howmedica screws in that they are self reaming and have thread lengths of 20 mm.
The EZ-FIX™ Cannulated Screws are substantially equivalent to the Alphatec screws In they are made available in fengths from 35 mm to 125 mm.
The EZ-Fix™ Cannulated Screws are substantially equivalent to the Howmedica and Richards screws in that they have a thread diameter of 7.3 mm (Howmedica and Richards screws have thread diameters of 7.0 mm and 8.0 mm respectively).
Image /page/1/Picture/18 description: The image shows the word "FAXED" with the date "10/29/91" written underneath the letters "A", "X", and "E". The word and date are written in a bold, blocky font. The image appears to be a stamp or a handwritten note.
2
Packaging:
The EZ-Fix™ Cannulated Screws and all instruments are supplied non-sterile.
Sterilization / Re-sterilization:
The EZ-Fix™ Cannulated Screws and all instruments are supplied non-sterile.
Steam autoclavable sterilization trays will be designed to contain the EZ-Fix™ Cannulated Screw System and maintain adequate separation of the implants and instruments.
Sterilization cycles should be followed appropriately to achieve a 10° sterility assurance level (SAL).
See Appendix I for Sterilization Procedure
The EZ-Fix™ is non-pyrogenic. Pyrogenicity testing of the EZ-Fix™ to determine level of endotoxin performed using LAL (Limulus Amebocyte Lysate) method.
Testing:
Awaiting from Orthopaedics Biomechanics Laboratory.
Equivalence :
These test values are identical to those obtained on the referenced equivalent.
Conclusion:
Based on the materials, intended uses, design, testing, and manufacturing, the EZ Fix™ Cannulated Screw System is equivalent to the referenced legally marketed comparison devices. The feature comparison chart below graphically demonstrates equivalence.
Comparison Table:
| EZ-FIx™
Cann. Screw | Alphatec Lg.
Cann. Screw | Ace®
Screw | Richards
Universal and 8 MM | Howmedica
Asnis 2™ | SE |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|----------------|------------------------------------|-----------------------|--------|
| Materials | | | | | |
| Titanium Alloy | Titanium Alloy | Titanium Alloy | Stainless Steel
Stainless Steel | Stainless Steel | Yes/No |
| MRI Compatible | | | | | |
| Yes | Yes | Yes | No
No | No | Yes/No |
| Cannulated | | | | | |
| Yes | Yes | Yes | Yes
Yes | Yes | Yes |
| Thread Diameter | | | | | |
| 7.3 MM | 6.5 MM | 6.5 MM | 6.5 MM
8.0 MM | 7.0 MM | Yes/No |
| Guide Pin Diameter | | | | | |
| 3.2 MM | 3.2 MM | 3.2 MM | 2.4 MM
3.2 MM | 3.2 MM | Yes/No |
| Screw Lengths | | | | | |
| 35 - 125 MM | 35 - 125 MM | 25-120 MM | 25 - 120 MM
50 - 125 MM | 35 -130 MM | Yes/No |
| Thread Lengths | | | | | |
| 20 MM | 20 MM | 20 MM | 16 MM
16 MM | 20 MM | Yes/No |
| Intended Use | | | | | |
| Single Use | Single Use | Single Use | Single Use
Single Use | Single Use | Yes |
| Indications | | | | | |
| Intracapsular,
certain cervical
and subcapital
fractures of the
femur. Distal femur
and proximal tibia
fractures. Pelvis
and acetabular
fractures. Certain
fractures of the
shoulder and elbow. | Same | Same | Same
Same | Same | Yes |
| Contraindications | | | | | |
| Attachment or
fixation to the
posterior elements
(pedicles) of the
cervical, thoracic,
or lumbar spine | Same | Same | Same
Same | Same | Yes |
| Performance Standards | | | | | |
| ASTM F117 | Same | Same | Same
Same | Same | Yes |
| Self Reaming | | | | | |
| Yes | Yes | Yes | No
No | Yes | Yes/No |
| Self Tapping | | | | | |
| Yes | Yes | Yes | Yes
Yes | Yes | Yes |
| Reverse Cutting | | | | | |
| Yes | Yes | No | Yes
Yes | Yes | Yes |
| Sterile | | | | | |
| Non-Sterile | Non-Sterile | Non-Sterile | Non-Sterile
Non-Sterile | Non-Sterile | Yes |
3