(93 days)
Not Found
No
The device description focuses on the mechanical properties and design of a surgical implant for fracture stabilization. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as a "Compression Hip/Supracondylar Screw system" used to stabilize various fractures of the femur, indicating its direct role in treating and repairing bodily injury, which aligns with the definition of a therapeutic device.
No.
The device is described as an orthopedic implant (screw system) used to stabilize fractures, not to diagnose medical conditions.
No
The device description explicitly details a physical implantable system made of titanium, including plates, screws, and a barrel, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for stabilizing bone fractures. This is a surgical implant, not a diagnostic test performed on biological samples.
- Device Description: The description details a physical implant made of titanium, including plates, screws, and a barrel. This is consistent with a surgical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information.
IVD devices are used to examine specimens from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device is a therapeutic device used to physically stabilize a fracture.
N/A
Intended Use / Indications for Use
The EZ-Fix™ Compression Hip Screw System is substantially equivalent to the Alphatec, Ace, Richards, Howmedica and Zimmer compression hip screw systems in that they are combination lag screw, bone screws, compression screw and plate fixation devices with indicated for single use to stabilize intracapsular fractures of the neck of the femur; class I, II, III, and IV trochanteric and subtrocianteric fractures with appropriate additional postoperative precautions against weight-bearing and against more than sedentary activity; supracondylar fractures and distal femoral fractures using a 95° barrel angle, making it substantially equivalent to Alphatec, Richards, Howmedica and Zimmer. The EZ-FIX™ CHS is contraindicated for attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
Product codes
87LXT
Device Description
The EZ-Fix™ Compression Hip/Supracondylar Screw system is manufactured from titanium (6Al-4V ELI) per ASTM F136. It is light weight. The barrel and plate (keyed and non-keyed) are one solid piece (non-modular), is available in 95°, 130°, 135°, 140°, 145° and 150° angles and is manufactured and tested per ASTM specifications F787 and F384 respectively. The bone screw hole pattern is offset and the most proximal hole accepts a large diameter cannulated screw. The plates shall be available in 3 hole, 4 hole, 5 hole, 6 hole, 10 hole, 12 hole and 14 hole lengths. The bone screws are self-tapping and the lag screws are available in 50-150 mm (5 mm increments) lengths. A compression screw threads into the lag screw to allow for optimal compression of the lag screw into the barrel during implantation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
neck of the femur; trochanteric and subtrocianteric fractures; supracondylar fractures and distal femoral fractures
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
The EZ-Fix™ Compression Hip/Supracondylar Screw (CHS) system has been tested by the University of Miami Biomechanics Laboratory at Mount Sinal in Miami Beach. Florida. based upon ASTM test standards for metallic nail-plate appliances (F384). Test results proved the device to be of sound design. These test values are comparable to those obtained from the referenced equivalent.
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
K96 2846
OCT 2 3 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 TM Compression Hip/Supracondylar Screw (CHS) System |
|---|---|
| Common Name: | Compression Hip/Supracondylar Screw |
| Registration Number: | 888.3030 |
| Classification Name: | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple |
| Component, Metal Composite | |
| Product Code: | 87LXT |
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.
1
Device Description:
The EZ-Fix™ Compression Hip/Supracondylar Screw system is manufactured from titanium (6Al-4V ELI) per ASTM F136. It is light weight. The barrel and plate (keyed and non-keyed) are one solid piece (non-modular), is available in 95°, 130°, 135°, 140°, 145° and 150° angles and is manufactured and tested per ASTM specifications F787 and F384 respectively. The bone screw hole pattern is offset and the most proximal hole accepts a large diameter cannulated screw. The plates shall be available in 3 hole, 4 hole, 5 hole, 6 hole, 10 hole, 12 hole and 14 hole lengths. The bone screws are self-tapping and the lag screws are available in 50-150 mm (5 mm increments) lengths. A compression screw threads into the lag screw to allow for optimal compression of the lag screw into the barrel during implantation.
Substantially Equivalent Devices:
| Alphatec Modular Hip Screw System |
|---|
| See Appendix III for promotional materials for the comparison device. |
-
- Ace Captured Hip Screw System See Appendix III for promotional materials for the comparison device.
-
- Richards Classic and AMBI Compression Hip Screw Systems See Appendix III for promotional materials for the comparison device.
- ব, Howmedica ALTA Modular Hip Screw System See Appendix III for promotional materials for the comparison device.
-
- Zimmer Free-Lock Compression Hip Fixation System See Appendix III for promotional materials for the comparison device. .. .
-
- Zimmer Versa-Fx Femoral Fixation System See Appendix III for promotional materials for the comparison device.
Comparison to Predicate Device:
The EZ-Fix™ Compression Hip Screw System is substantially equivalent to the Alphatec, Ace, Richards, Howmedica and Zimmer compression hip screw systems in that they are combination lag screw, bone screws, compression screw and plate fixation devices with indicated for single use to stabilize intracapsular fractures of the neck of the femur; class I, II, III, and IV trochanteric and subtrocianteric fractures with appropriate additional postoperative precautions against weight-bearing and against more than sedentary activity; supracondylar fractures and distal femoral fractures using a 95° barrel angle, making it substantially equivalent to Alphatec, Richards, Howmedica and Zimmer. The EZ-FIX™ CHS is contraindicated for attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine. It is fabricated and tested per ASTM standards.
The EZ-Fix™ CHS is substantially equivalent to the Alphatec, Richards, Howmedica and Zimmer systems in that it include self-tapping bone screws.
The EZ-Fix™ CHS is substantially equivalent to Alphatec, Richards' Classic, Howmedica and Zimmer in that it accepts a large cannulated screw in the most proximal plate hole.
2
The EZ-Fix™ CHS is substantially equivalent to Alphatec, Ace, and Howmedica in that it is fabricated from titanium alloy (71-6Al-4V ELI). It is equivalent to the Richards, and Zimmer systems in that the barrel and plate are non-modular (solid) in design and the screw hole pattern along the length of the plate is offset.
The EZ-Fix™ CHS is substantially equivalent to Alphatec, Richards' AMBI, Howmedica, and Zimmer Free-Lock being available keyed or keyless with regard to the barrel and lag screw design.
The EZ-Fix™ CHS is substantially equivalent to Alphatec, Richards, Howmedica, and Zimmer Versa Fx in that the barrel plate angles include 95°, 130°, 135°, and 150°. Like Alphatec, the EZ-Fix™ lag screws are available in lengths ranging from 50 mm to 150 mm.
Packaging:
Sterlle
· The EZ-Fix™ Compression Hip Screw devices may be supplied sterile.
· The devices are packaged individually in a blister package consisting of a thermoformed inner tray that contains the EZ-Fix™ Rod. This tray is protected by an outer thermoformed tray that is sealed by TVVEK CR-27. The outer TYVEK cover is labeled and has affixed to it the Patient Chart Labels. Both the inner and outler trays when sealed with the TYVEK cover are enclosed in a box that is sealed and indicates the sterility of the contents. Packaging material consists of .025 BT/CTD PETG, WEB#1:CTD 1073B TYVEK CR-27.
Non-Sterile
· The EZ-Fix™ Compression Hip Screw devices and all instrumentation may be supplied non-sterile.
· Steam autoclavable sterilization trays have been designed to contain the EZ-Fix™ CHS System and maintain adequate separation of the implants and instruments.
Sterilization / Re-sterilization:
Sterlie
· The EZ-Fix™ Compression Hip Screw devices may be supplied sterlie.
- · Sterilization is achieved by means of gamma radiation.
- · Sterilization complies with ANSVAAMVISO 11137-1994 practices.
· 10% of each production lot of EZ-Fix™ devices are tested (6% for bacteriostasis -
fungistasis studies and 4% for bloburden recovery determination)
· The devices are packaged individually in a blister package consisting of a thermoformed inner tray that contains the EZ-Fix™ Rod. This tray is protected by an outer thermoformed tray that is sealed by TYVEK CR-27. The outer TYVEK cover is labeled and has affixed to it the Patient Chart Labels. Both the inner and outler trays when sealed with the TYVEK cover are enclosed in a box that is sealed and indicates the sterility of the contents. Packaging material consists of .025 BT/CTD PETG, WEB#1:CTD 1073B TYVEK CR-27.
- · The radiation dose is based on the ANSVAAMI/ISO 11137.1994 dose setting.
- · Sterilization Assurance Level (SAL) is 10°.
3
· Sterilization process used is Cobalt 60.
· The EZ-Fix™ devices are non-pyrogenic. Pyrogenicity testing of the devices to determine level of endotoxin performed using LAL (Limulus Amebocyte Lysate) method.
Non-Sterile
· The EZ-Fix™ Compression Hip Screw devices and all instrumentation may be supplied non-sterile.
· Steam autoclavable sterilization travs have been designed to contain the EZ-Fix™ CHS 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™ devices are non-pyrogenic. Pyrogenicity testing of the devices to determine level of endotoxin performed using LAL (Limulus Amebocyte Lysate) method.
Testing:
The EZ-Fix™ Compression Hip/Supracondylar Screw (CHS) system has been tested by the University of Miami Biomechanics Laboratory at Mount Sinal in Miami Beach. Florida. based upon ASTM test standards for metallic nail-plate appliances (F384). Test results proved the device to be of sound design.
Equivalence :
These test values are comparable to those obtained from the referenced equivalent.
Conclusion:
1
Based on the materials, intended uses, design, testing, and manufacturing, the EZ Fix™ Compression Hip/Supracondylar Screw System is equivalent to the referenced legally marketed comparison devices. The feature comparison chart below graphically demonstrates equivalence.
Comparison Table:
| EZ-Fix™
CHS | Alphatec
MHS | Ace®
CHS | Richards
AMBI / Classic | Howmedica
Alta | Zimmer
Free Lock / Versa |
|-----------------|-----------------|----------------|------------------------------------|-------------------|------------------------------------|
| Materials | | | | | |
| Titanium Alloy | Titanium Alloy | Titanium Alloy | Stainless Steel
Stainless Steel | Titanium Alloy | Stainless Steel
Stainless Steel |
| Keyed / Keyless | | | | | |
| Both | Both | Keyless | Keyable
Keyed | Both | Keyable
Keyed |
| Plate Design | | | | | |
| Solid | Modular | Modular | Solid
Solid | Modular | Solid
Solid |