EZ-FIX CANNULATED SCREW SYSTEM

K962706 · Biodynamic Technologies, Inc. · HWC · Nov 13, 1996 · Orthopedic

Device Facts

• Record ID: K962706
• Device Name: EZ-FIX CANNULATED SCREW SYSTEM
• Applicant: Biodynamic Technologies, Inc.
• Product Code: HWC · Orthopedic
• Decision Date: Nov 13, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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 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, lumbar spine.

Device Story

EZ-Fix™ Cannulated Screw System consists of titanium alloy (Ti-6Al-4V ELI) bone fixation screws; used by orthopedic surgeons for fracture stabilization in femur, tibia, pelvis, acetabulum, shoulder, and elbow. Screws feature 7.3 mm thread diameter, 20 mm thread length, and 3.45 mm cannulation for 3.2 mm guide pin placement. Design includes self-reaming, self-tapping, and reverse-cutting flutes. Supplied non-sterile; requires steam autoclave sterilization by user. Device provides mechanical fixation to facilitate bone healing; clinical benefit derived from stabilization of fractures.

Clinical Evidence

No clinical data provided. Equivalence established via design comparison and mechanical testing performed by Orthopaedics Biomechanics Laboratory, with results reported as identical to referenced predicate devices.

Technological Characteristics

Material: Titanium alloy (Ti-6Al-4V ELI). Dimensions: 7.3 mm thread diameter, 20 mm thread length, 3.45 mm cannulation. Features: Self-reaming, self-tapping, reverse-cutting flutes. Standards: Tested per ASTM F117. Sterilization: Non-sterile, steam autoclavable. Energy source: None (mechanical).

Indications for Use

Indicated for single-use stabilization of intracapsular, cervical, and subcapital femur fractures; distal femur and proximal tibia fractures; pelvis and acetabular fractures; and specific shoulder and elbow fractures. Contraindicated for fixation to posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

Regulatory Classification

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.

Predicate Devices

• Alphatec Large Cannulated Screw System
• Richards Universal and 8.0 mm Cannulated Screw
• Ace Screw
• Howmedica Asnis 2 Guided Screw System

Submission Summary (Full Text)

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K962706

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
[phone] [phone] 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
[phone] [phone] 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

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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, lumbar spine.

The EZ-Fix™ Cannulated Screws are fabricated from titanium alloy (Ti-6Al-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:

1. Alphatec Large Cannulated Screw System
See Appendix III for promotional materials for the comparison device.

2. Richards Universal and 8.0 mm Cannulated Screw
See Appendix III for promotional materials for the comparison device.

3. Ace Screw
See Appendix III for promotional materials for the comparison device.

4. 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 guide pin, they are self tapping, and they are supplied non-sterile. Like Alphatec, Richards and Howmedica, they have reverse cutting flutes.

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 lengths 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).

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# 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 10⁻⁶ 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:

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
Asnls 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 |

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| 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 |