(58 days)
Not Found
Not Found
No
The description focuses solely on the mechanical design and materials of a physical implantable device, with no mention of software, algorithms, or data processing.
Yes.
The device is used for internal skeletal fixation to stabilize midshaft fractures of the humerus, which is a therapeutic purpose.
No
Explanation: The device is described as an "internal skeletal fixation device indicated for intramedullary use to stabilize midshaft fractures of the humerus." Its purpose is to stabilize fractures, not to diagnose a condition.
No
The device description clearly describes a physical, implantable intramedullary rod made of titanium alloy, which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description: The EZ-Fix™ Midshaft Humeral Intramedullary Rod is an internal skeletal fixation device. It is implanted inside the body to stabilize bone fractures.
The description clearly states its purpose is to physically fix a bone fracture, not to perform diagnostic testing on a biological sample.
N/A
Intended Use / Indications for Use
The EZ-Fix™ Midshaft Humeral Intramedullary Rod is an internal skeletal fixation device indicated for intramedullary use to stabilize midshaft fractures of the humerus.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
The EZ-Fix™ Midshaft Humeral Intramedullary Rod is an internal skeletal fixation device indicated for intramedullary use to stabilize midshaft fractures of the humerus. The device has been engineered for ease of use and the ability to accommodate a wide variety of Midshaft Humeral fractures.
The EZ-Fix™ Midshaft Humeral IM Rod System is substantially equivalent to the Orthologic® OrthoNall® Humeral Intramedullary Fixation Device, the Applied Osteo Systems True/Flex™ Fixation Device, the Howmedica Seidel™ Humeral Locking Nail System, and the Howmedica Alta@Humeral Rod.
The EZ-Fix™ Midshaft Humeral Rod is cylindrical and available in 9mm, 11mm and 13mm diameters. The 9mm rod reduces to 7mm distally and is available in 200mm and 250mm lengths. The 11mm rod reduces to 9mm distally and is available in 200mm and 250mm lengths. The 13mm rod reduces to 11mm distally and is available in 200mm and 250mm lengths. Three screw holes proximally accept 5mm bone screws. Tuberosity fragments can be stabilized by transfixing screws. Two holes distally accept 3.5mm screws to capture and secure distal fragments or to enhance rotational stability.
The EZ-Fix™ Midshaft Humeral Rod has shallow grooves situated from the beginning of the taper and extending lengthwise for ease of implantation, enhanced flexibility and rotational stability.
An insertion/extraction instrumentation attachment hole is located in the proximal end of the rod. This threaded hole is profected by a titanlum allov (T1-6AL-4V) capscrew, disallowing soft tissue ingrowth post implantation.
The EZ-Fix™ Midshaft Humeral Rod is titanium alloy (TI-6AL-4V) for biocompatibility and strength.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Midshaft Humeral
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)
The EZ-Fix™ Midshaft Humeral IM Rod has been tested by the University of Miami Biomechanics Laboratory at Mount Sinai in Miami Beach, Florida, based upon ASTM test standards for intermedullary rods (F383). Test results proved the rods to be of sound design.
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.
The EZ-Fix™ Midshaft Humeral IM Rod System is substantially equivalent to the Orthologic® OrthoNall® Humeral Intramedullary Fixation Device, the Applied Osteo Systems True/Flex™ Fixation Device, the Howmedica Seidel™ Humeral Locking Nail System, and the Howmedica Alta@Humeral Rod.
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.
Not Found
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
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.
0
AUG 2 8 1998
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™ Midshaft Humeral Intramedullary Rod System |
|---|---|
| Common Name: | Intramedullary Rods |
| Registration Number: | 888.3020 |
| Classification Name: | Rod, Fixation, Intramedullary and Accessories |
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
Contact Person:
Danny Hodgeman Biodynamic Technologies, Inc. East Newport Center Drive Deerfield Beach, Florida 33442 (305) 421-3166 (305) 570-6368 FAX
Classification:
Device Class: Class II
Classification Panel: Orthopedic
Special Controls:
Not applicable to this device.
1
Device Description:
The EZ-Fix™ Midshaft Humeral Intramedullary Rod is an internal skeletal fixation device indicated for intramedullary use to stabilize midshaft fractures of the humerus. The device has been engineered for ease of use and the ability to accommodate a wide variety of Midshaft Humeral fractures.
The EZ-Fix™ Midshaft Humeral IM Rod System is substantially equivalent to the Orthologic® OrthoNall® Humeral Intramedullary Fixation Device, the Applied Osteo Systems True/Flex™ Fixation Device, the Howmedica Seidel™ Humeral Locking Nail System, and the Howmedica Alta@Humeral Rod.
The EZ-Fix™ Midshaft Humeral Rod is cylindrical and available in 9mm, 11mm and 13mm diameters. The 9mm rod reduces to 7mm distally and is available in 200mm and 250mm lengths. The 11mm rod reduces to 9mm distally and is available in 200mm and 250mm lengths. The 13mm rod reduces to 11mm distally and is available in 200mm and 250mm lengths. Three screw holes proximally accept 5mm bone screws. Tuberosity fragments can be stabilized by transfixing screws. Two holes distally accept 3.5mm screws to capture and secure distal fragments or to enhance rotational stability.
The EZ-Fix™ Midshaft Humeral Rod has shallow grooves situated from the beginning of the taper and extending lengthwise for ease of implantation, enhanced flexibility and rotational stability.
An insertion/extraction instrumentation attachment hole is located in the proximal end of the rod. This threaded hole is profected by a titanlum allov (T1-6AL-4V) capscrew, disallowing soft tissue ingrowth post implantation.
The EZ-Fix™ Midshaft Humeral Rod is titanium alloy (TI-6AL-4V) for biocompatibility and strength.
Substantially Equivalent Devices:
Orthologic® OrthoNail® Humeral Intramedullary Fixation Device See Appendix III for promotional materials for the comparison device.
Applied Osteo Systems True/Flex™
See Appendix III for promotional materials for the comparison device.
Howmedica Seidel™ Humeral Locking Nail System See Appendix III for promotional materials for the comparison device.
Howmedica Alta®Humeral Rod See Appendix III for promotional materials for the comparison device.
Comparison to Predicate Device:
The EZ-Fix™ Humeral Rod is substantially equivalent to the OrthoNail®, the True/Flex™ and the Alta®, in that it is manufactured from titanium or titanium alloy. Like the OrthoNail®, the Seidel™, and the Alta®, the EZ-Fix™ is of a cvlindrical configuration proximally.
2
The EZ-Fix™ is indicated for Midshaft Humeral fractures as is the OrthoNail®, the True/Flex™, the Seider™, and the Alta®. Like the OrthoNail®, the Seidel™, and the Alta®, the EZ-Fix™ has screw holes for fixation.
The EZ-Fix™ is equivalent to OrthoNail®, the Alta™, and the Seidel in that it is cannulated. Like the OrthoNail®, the EZ-Fix™ threaded insertion/extraction hole is protected by a titanium alloy capscrew, disallowing soft tissue ingrowth post implantation.
Packaging:
Sterlie
The EZ-Fix™ Midshaft Humeral Intramedullary Rods are packaged in a blister package consisting of a thermoformed inner tray that contains the EZ-Flx™ 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 Patlent Chart Labels. Both the inner and outer 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™ Midshaft Humeral Intramedullary Rod System includes EZ-Fix™ midshafts humeral rods and instrumentation and is made available non-sterile. Steam autoclavable sterlization trays have been designed to contain the EZ-Fix™ Rod System and maintain adequate separation of the implants and instruments. Sterillzation cvcles should be followed appropriately to achieve a 10ª sterility assurance level (SAL).
Sterilization / Re-sterilization:
Sterile
- · The EZ-Fix™ Midshaft Humeral Intramedullary Rod may be supplied sterile.
- · Sterilization is achieved by means of gamma radiation.
- · Sterilization complies with ANSI/AAMVISO 11137-1994 practices.
· 10% of each production lot of EZ-Fix™ kits are tested (6% for bacteriostasis fungistasis studies and 4% for bioburden recovery determination)
· The EZ-Fix™ is packaged in a blister package consisting of a thermoformed inner tray that contains the EZ-FIX™ Rod. This trav 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 outer 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 ANSVAAMVISO 11137.1994 dose setting.
- · Sterilization Assurance Level (SAL) is 10°.
- · Sterilization process used is Cobalt 60.
· The EZ-Fix™ is non-pyrogenic. Pyrogenicity testing of the EZ-Fix™ to determine level of endotoxin performed using LAL (Limulus Amebocyte Lysate) method.
3
Non-Sterile
· The EZ-Fix™ Humeral Intramedullary Rods and all instrumentation may be supplied non-sterile.
· Steam autoclavable sterilization trays have been designed to contain the EZ-Fix™ Rod 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-pvrogenic. Pyrogenicity testing of the EZ-Fix™ to determine level of endotoxin performed using LAL (Limulus Amebocyte Lysate) method.
Testing:
The EZ-Fix™ Midshaft Humeral IM Rod has been tested by the University of Miami Biomechanics Laboratory at Mount Sinai in Miami Beach, Florida, based upon ASTM test standards for intermedullary rods (F383). Test results proved the rods to be of sound design.
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™ Proximal Humeral Intramedullary Rod System is equivalent to the referenced legally marketed comparison devices. The feature comparison chart below graphically demonstrates equivalence.
4
Comparison Table:
| EZ-Fix™ | OrthoNall® | Alta™ | True/Flex™ | Seidel™ | Substantial
Equivalence |
|-----------------------|---------------------------------------------------|------------------------------------------------|--------------------------------------------------|------------------------------------------------------|----------------------------|
| Materials | Titanium Alloy | Titanium Alloy | Titanium Alloy | Stainless Steel | Yes |
| Geometry | Cylindrical/Flat | Cylindrical | Star Shaped | Cylindrical | Yes |
| Intended Use | Single Use
Prox/Distal
Humeral
Fractures | Single Use
Midshaft
Humeral
Fractures | Single Use
Mid/Distal
Humeral
Fractures | Single Use
Prox/Mid Shaft
Humeral
Fractures | Yes |
| Performance Standards | ASTM | ASTM | ASTM | ASTM | Yes |
| Fixation | Interference
Optional
Screw Holes | Interference
Optional
Screw Holes | Interference
Mechanism | Interference
Mechanism | Yes |
| Preparation (Reaming) | Optional | Optional | No | Yes | Yes |
| Cannulated | Yes | Yes/No | No | Yes | Yes |
| Sterile | Non-Sterile | Sterile | Sterile | Sterile | Yes |
・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・
: