(86 days)
Orthologic® OrthoNall® Humeral Intramedullary Fixation Device, Acumed™ Polarus® Proximal Humeral Fixation System, Applied Osteo Systems True/Flex™ Fixation Device., Howmedica Seidel™ Humeral Locking Nail System
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No
The description focuses on the mechanical design and materials of a physical implantable device, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is described as an internal skeletal fixation device, which is a structural implant to stabilize fractures, not a device that applies therapies (like electrical stimulation, heat, or vibration) for treatment.
No
The device is an internal skeletal fixation device designed to stabilize fractures, meaning it is a therapeutic device, not a diagnostic one.
No
The device description clearly details a physical, implantable intramedullary rod made of titanium alloy with specific dimensions, screw holes, and slots. This is a hardware device, not software.
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 for diagnosis, monitoring, or screening.
- Device Description: The EZ-Fix™ Proximal Humeral Intramedullary Rod is an internal skeletal fixation device. It is surgically implanted into the bone to stabilize fractures.
- Intended Use: Its intended use is to stabilize fractures of the proximal humerus. This is a therapeutic intervention, not a diagnostic test performed on a specimen.
The description clearly indicates a surgical implant used for structural support within the body, which is the opposite of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The EZ-Fix™ Proximal Humeral Intramedullary Rod is an internal skeletal fixation device indicated for intramedullary use to stabilize fractures of the proximal humerus.
Product codes
888.3020
Device Description
The EZ-Fix™ Proximal Humeral Intramedullary Rod is an internal skeletal fixation device indicated for intramedullary use to stabilize fractures of the proximal humerus. The device has been engineered for ease of use and the ability to accommodate a wide variety of proximal humeral fractures.
The EZ-Fix™ Humeral Rod is cylindrical and available in 9mm, 11mm, 13mm and 15mm diameters and is approximately 155mm in length. Proximally there are four screw holes for capturing and stabilizing humeral head fragments. Most proximally, the EZ-Fix™ Humeral Rod accepts a 6.5mm cannulated screw. Two holes, one 60 degrees anterior and one 60 degrees posterior from the lateral side, accept 5mm bone screws. The most distal hole also accepts a 5mm bone screw and is aligned laterally with the most proximal screw hole.
In addition to the four proximal holes in the 11mm. 13mm and 15mm rods, there are four suture holes proximally to attach soft tissues.
The EZ-Fix™ Humeral Rod is tri-sloted distally allowing the rod to collapse and accommodate anatomical variances. These three slots are of different lengths and extend from the distal end of the rod to just below the four proximal screw holes.
The EZ-Fix™ Humeral Rod has shallow grooves situated below the screw holes and extending lengthwise for ease of implantation without reaming, enhanced flexibility and rotational stability.
An insertion/extraction instrumentation attachment hole is located in the proximal end of the rod. This threaded hole is protected by a titanium alloy (TI-6AL-4V) capscrew. disallowing soft tissue ingrowth post implantation.
The EZ-Fix™ 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
proximal humerus
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™ Proximal 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.
Orthologic® OrthoNall® Humeral Intramedullary Fixation Device, Acumed™ Polarus® Proximal Humeral Fixation System, Applied Osteo Systems True/Flex™ Fixation Device., Howmedica Seidel™ Humeral Locking Nail System
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.
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SEP 2 5 1996
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™ Proximal Humeral Intramedullary Rod System
Common Name: Intrameduliary 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.
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Device Description:
The EZ-Fix™ Proximal Humeral Intramedullary Rod is an internal skeletal fixation device indicated for intramedullary use to stabilize fractures of the proximal humerus. The device has been engineered for ease of use and the ability to accommodate a wide variety of proximal humeral fractures.
The EZ-Fix™ Humeral Rod is cylindrical and available in 9mm, 11mm, 13mm and 15mm diameters and is approximately 155mm in length. Proximally there are four screw holes for capturing and stabilizing humeral head fragments. Most proximally, the EZ-Fix™ Humeral Rod accepts a 6.5mm cannulated screw. Two holes, one 60 degrees anterior and one 60 degrees posterior from the lateral side, accept 5mm bone screws. The most distal hole also accepts a 5mm bone screw and is aligned laterally with the most proximal screw hole.
In addition to the four proximal holes in the 11mm. 13mm and 15mm rods, there are four suture holes proximally to attach soft tissues.
The EZ-Fix™ Humeral Rod is tri-sloted distally allowing the rod to collapse and accommodate anatomical variances. These three slots are of different lengths and extend from the distal end of the rod to just below the four proximal screw holes.
The EZ-Fix™ Humeral Rod has shallow grooves situated below the screw holes and extending lengthwise for ease of implantation without reaming, enhanced flexibility and rotational stability.
An insertion/extraction instrumentation attachment hole is located in the proximal end of the rod. This threaded hole is protected by a titanium alloy (TI-6AL-4V) capscrew. disallowing soft tissue ingrowth post implantation.
The EZ-Fix™ Humeral Rod is titanium alloy (TI-6AL-4V) for biocompatibility and strength.
Substantially Equivalent Devices:
Orthologic® OrthoNall® Humeral Intramedullary Fixation Device
Acumed™ Polarus® Proximal Humeral Fixation System
Applied Osteo Systems True/Flex™ Fixation Device.
Howmedica Seidel™ Humeral Locking Nail System
Comparison to Predicate Device:
The EZ-Fix™ Humeral Rod is substantially equivalent to the OrthoNail®, the Polarus®, and the True/Flex™ in that it is manufactured from titanium or thanium allov. Like the OrthoNall®, the Polarus®, and the Seidel™, the EZ-Fix™ is of a cyfindrical configuration, proximally.
The EZ-Fix™ is indicated for proximal humeral fractures as is the OrthoNail®, the Polarus®, and the Seidel™. Like the OrthoNail®, the Polarus®, and the Seidel™, the
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EZ-Fix™ has screw holes for fixation. In addition. the EZ-Fix™ has suture holes proximal like the OrthoNail®.
The EZ-Fix™ is equivalent to the True/Flex™ in that reaming is not required and neither devices are 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:
Sterile
The EZ-Fix™ Proximal Humeral Intramedullary Rods are packaged in a blister package consisting of a thermoformed inner tray that contains the EZ-Fix™ Rod. This tray is protected by an outer thermoformed trav 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 travs 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™ Proximal Humeral Intramedullary Rod System includes EZ-Fix™ humeral rods and instrumentation and is made available 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).
Sterilization / Re-sterilization:
Sterile
- · The EZ-Fix™ Proximal Humeral Intrameduliary Rod may be supplied sterile.
- · Sterilization is achieved by means of gamma radiation.
- · Sterilization complies with ANSVAAMI/ISO 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 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 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 ANSVAAMI/ISO 11137.1994 dose setting.
- · Sterilization Assurance Level (SAL) is 10ª.
- · Sterilization process used is Coball 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.
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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-pyrogenic. Pyrogenicity testing of the EZ-Fix™ to determine level of endotoxin performed using LAL (Limulus Amebocyte Lysate) method.
Testing:
The EZ-Fix™ Proximal 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.
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Comparison Table:
| EZ-Fix™ | OrthoNail® | Polarus® | True/Flex™ | Seldel™ | Substantial
Equivalence |
|------------------------------------------------|---------------------------------------------------|------------------------------------------------|--------------------------------------------------|------------------------------------------------------|----------------------------|
| Materials | | | | | |
| Titanium Alloy | Titanium Alloy | Titanium | Titanium Alloy | Stainless Steel | Yes |
| Geometry | | | | | |
| Cylindrical | Cylindrical/Flat | Cylindrical | Star Shaped | Cylindrical | Yes |
| Intended Use | | | | | |
| Single Use
Proximal
Humeral
Fractures | Single Use
Prox/Distal
Humeral
Fractures | Single Use
Proximal
Humeral
Fractures | Single Use
Mid/Distal
Humeral
Fractures | Single Use
Prox/Mid Shaft
Humeral
Fractures | Yes |
| Performance Standards | | | | | |
| ASTM | ASTM | ASTM | ASTM | ASTM | Yes |
| Fixation | | | | | |
| Interference
Optional
Screw Holes | Interference
Optional
Screw Holes | Interference
Optional
Screw Holes | Interference
Mechanism | Interference
Mechanism | Yes |
| Preparation (Reaming) | | | | | |
| Optional | Yes | Yes | No | Yes | Yes |
| Cannulated | | | | | |
| No | Yes | Yes | No | Yes | Yes |
| Sterile | | | | | |
| Sterile
Non-Sterile | Non-Sterile | Sterile | Sterile | Sterile | Yes |
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