EZ-FIX MIDSHAFT HUMERAL INTRAMEDULLARY ROD SYSTEM
Device Facts
| Record ID | K962553 |
|---|---|
| Device Name | EZ-FIX MIDSHAFT HUMERAL INTRAMEDULLARY ROD SYSTEM |
| Applicant | Biodynamic Technologies, Inc. |
| Product Code | HSB · Orthopedic |
| Decision Date | Aug 28, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3020 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended 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.
Device Story
EZ-Fix™ Midshaft Humeral Intramedullary Rod is an internal skeletal fixation device for stabilizing midshaft humeral fractures. Device is a cylindrical titanium alloy (TI-6AL-4V) rod available in 9mm, 11mm, and 13mm diameters with varying distal tapers. Features include proximal screw holes for 5mm bone screws to stabilize tuberosity fragments and distal holes for 3.5mm screws to enhance rotational stability. A proximal threaded hole for insertion/extraction instrumentation is protected by a titanium capscrew to prevent soft tissue ingrowth. Device is implanted by a surgeon in a clinical/OR setting. It provides mechanical stabilization of bone fragments to facilitate healing. Available sterile (gamma radiation) or non-sterile (steam autoclavable).
Clinical Evidence
Bench testing only. Mechanical testing performed at the University of Miami Biomechanics Laboratory per ASTM F383 standards for intramedullary rods. Results confirmed sound design and equivalence to predicate devices.
Technological Characteristics
Material: Titanium alloy (TI-6AL-4V). Geometry: Cylindrical with longitudinal grooves for flexibility. Dimensions: 9mm, 11mm, 13mm diameters; 200mm and 250mm lengths. Fixation: Proximal and distal screw holes. Sterilization: Gamma radiation (sterile) or steam autoclave (non-sterile) per ANSI/AAMI/ISO 11137-1994. Standards: ASTM F383.
Indications for Use
Indicated for patients with midshaft humeral fractures requiring internal skeletal fixation.
Regulatory Classification
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.
Predicate Devices
- Orthologic® OrthoNail® Humeral Intramedullary Fixation Device
- Applied Osteo Systems True/Flex™ Fixation Device
- Howmedica Seidel™ Humeral Locking Nail System
- Howmedica Alta® Humeral Rod
Related Devices
- K962552 — EZ-6 PROXIMAL HUMERAL INTERAMEDULLARY ROD SYSTEM · Biodynamic Technologies, Inc. · Sep 25, 1996
- K042332 — TITANIUM TELEGRAPH HUMERAL NAIL · Fournitures Hospitalieres Industrie · Oct 7, 2004
- K963026 — TBD · Acu Med, Inc. · Oct 28, 1996
- K090478 — AOS PROXIMAL HUMERAL NAIL · Advanced Orthopaedic Solutions, Inc. · Mar 26, 2009
- K023241 — TELEGRAPH HUMERAL NAIL · Fournitures Hospitalieres Industrie · Dec 24, 2002
Submission Summary (Full Text)
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K962553
AUG 28 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™ 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.
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# 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® OrthoNail® 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 protected by a titanium alloy (TI-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 cylindrical configuration proximally.
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The EZ-Fix™ is indicated for Midshaft Humeral fractures as is the OrthoNail®, the True/Flex™, the Seidel™, 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:
### Sterile
The EZ-Fix™ Midshaft 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 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.
### 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 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 10⁻⁶ 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/AAMI/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 ANSI/AAMI/ISO 11137.1994 dose setting.
- Sterilization Assurance Level (SAL) is 10⁻⁶.
- 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.
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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 10⁻⁶ 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™ 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.
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Comparison Table:
| EZ-Fix™ | OrthoNail® | Alta™ | True/Flex™ | Seidel™ | Substantial Equivalence |
| --- | --- | --- | --- | --- | --- |
| Materials | | | | | |
| Titanium Alloy | Titanium Alloy | Titanium Alloy | Titanium Alloy | Stainless Steel | Yes |
| Geometry | | | | | |
| Cylindrical | Cylindrical/Flat | Cylindrical | Star Shaped | Cylindrical | Yes |
| Intended Use | | | | | |
| Single Use | Single Use | Single Use | Single Use | Single Use | Yes |
| Midshaft | Prox/Distal | Midshaft | Mid/Distal | Prox/Mid Shaft | |
| Humeral | Humeral | Humeral | Humeral | Humeral | |
| Fractures | Fractures | Fractures | Fractures | Fractures | |
| Performance Standards | | | | | |
| ASTM | ASTM | ASTM | ASTM | ASTM | Yes |
| Fixation | | | | | |
| Interference | Interference | Interference | Interference | Interference | Yes |
| Optional | Optional | Optional | Mechanism | Mechanism | |
| Screw Holes | Screw Holes | Screw Holes | | | |
| Preparation (Reaming) | | | | | |
| Optional | Optional | Optional | No | Yes | Yes |
| Cannulated | | | | | |
| Yes | Yes | Yes/No | No | Yes | Yes |
| Sterile | | | | | |
| Sterile | Non-Sterile | Sterile | Sterile | Sterile | Yes |
| Non-Sterile | | | | | |
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