K2 BONE SCREW SYSTEM

K960537 · Kinetikos Medical, Inc. · HWC · Mar 25, 1996 · Orthopedic

Device Facts

• Record ID: K960537
• Device Name: K2 BONE SCREW SYSTEM
• Applicant: Kinetikos Medical, Inc.
• Product Code: HWC · Orthopedic
• Decision Date: Mar 25, 1996
• Decision: SN
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The KMI K2 Bone Screw System™ will be used on indications that are common with presently marketed devices. The indications for use of the K2 Bone Screw System™ are fixation/stabilization of small bone hand or small bone forefoot fractures.

Device Story

K2 Bone Screw System consists of titanium alloy (Ti-6Al-4V ELI) bone screws designed for fracture fixation and stabilization in small bones (hand/forefoot). Screws are available in 2.4 mm and 2.8 mm diameters with varying lengths. Implantation is performed by orthopedic surgeons using standard manual cannulated hexhead screwdrivers. The device provides mechanical stabilization of bone fragments to facilitate healing. The system is supplied non-sterile and requires sterilization by the user prior to surgery. Clinical benefit is derived from established orthopedic principles of internal fixation used for over 75 years.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on the long-standing clinical history (over 75 years) of bone screw designs for fracture fixation and stabilization, and adherence to standardized manufacturing and material specifications.

Technological Characteristics

Material: Ti-6Al-4V ELI titanium alloy (ASTM F136-84). Instrumentation: Stainless steel (ASTM F899-84). Diameters: 2.4 mm and 2.8 mm. Design: Threaded bone fixation fastener. Sterilization: Supplied non-sterile; user-sterilized per provided guidelines.

Indications for Use

Indicated for fixation and stabilization of small bone fractures in the hand or forefoot.

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

• Ace Medical Company (K903810)
• Alphatec Medical (K921622)
• Howmedica (K931524)
• Aesculap (K940207)
• Osteomed (K924018)
• Zimmer (K792022)
• A.O. Synthes (K792291)
• Johnson & Johnson (K?)
• ISI Manufacturing (K?)

Submission Summary (Full Text)

{0}

KINETIKOS MEDICAL KMI INCORPORATED

Confidential

MAR 25 1990

K960537

FDA Notification of:

Summary of Safety and Effectiveness Information
Product: K2 Bone Screw System™

# Summary of Safety and Effectiveness Information

For Release Upon Request Only

## Regulatory Authority:

Safe Medical Devices Act of 1990, 21 CFR 807.92

## Company Name / Contact:

**Company:** KMI (Kinetikos Medical Inc.)
3950 Sorrento Valley Blvd
San Diego, Ca 92110

**Contact:** Regulatory Affairs Department
KMI
3950 Sorrento Valley Blvd
San Diego, Ca 92110
[phone]

**Establishment Registration Number:** 2028840

**Classification Name:** Smooth or Threaded Bone Fixation Fastener

**Common Used Name:** Bone Screw

**Trade Proprietary Name:** K2 Bone Screw System™

The FDA has classified similar products as a Class II device by the Orthopedic Device Section of the Surgical and Rehabilitation Devices Panel at Section 888-304. The product code generally refereed to is HWC (Product Code: HWC), and KMI submits this application under this designation.

3950 SORRENTO VALLEY BLVD., SAN DIEGO, CALIFORNIA 92121 TELEPHONE: [phone] FACSIMILE: [phone]

{1}

KINETIKOS MEDICAL
KMI
INCORPORATED
Confidential

FDA Notification of:

Summary of Safety and Effectiveness Information
Product: K2 Bone Screw System™

## Performance Standards:

No performance standards applicable to the Bone Screw have been established by the FDA. However, the titanium alloy 6AL-4V ELI alloy used to manufacture the KMI screws meets the chemical and mechanical requirements in voluntary standards established by the American Society for Testing and Materials (ASTM F136-84).

## Package and Labeling:

Package labeling has been developed to industry standards. Packaging is also standard commercially available type quality and is stored in a fashion which prevents damage to the container or package the device is in.

## System Description:

The KMI K2 Bone Screw System™ will be offered in Ti-6Al-4V ELI. It will be available in common styles and assorted lengths for bone fracture fixation and stabilization. Initially, a range of eleven screw lengths will be made available in 2.8 mm diameter (10-30 mm), and eight screw lengths will be made available in the 2.4 mm (6-20 mm) diameter screw. Both screw types are implantable using a standard (e.g. American Orthopedic) hexhead screwdriver, which is cannulated at center.

## Indications for Use:

The KMI K2 Bone Screw System™ will be used on indications that are common with presently marketed devices. The indications for use of the K2 Bone Screw System™ are fixation/stabilization of small bone hand or small bone forefoot fractures.

3950 SORRENTO VALLEY BLVD., SAN DIEGO, CALIFORNIA 92121 TELEPHONE: [phone] FACSIMILE: [phone]

{2}

KINETIKOS MEDICAL
KMI
Confidential

# FDA Notification of: Summary of Safety and Effectiveness Information
## Product: K2 Bone Screw System™

### Substantial Equivalent Devices:

This product is substantially equivalent in design, composition and function to other orthopedic screws manufactured and approved for market.

- Ace Medical Company: K903810
- Alphatec Medical: K921622
- Howmedica: K931524
- Aesculap: K940207
- Osteomed: K924018
- Zimmer: K792022
- A.O. Synthes: K792291
- Johnson & Johnson: K?
- ISI Manufacturing: K?

The KMI K2 Bone Screw System™ meet the ASTM standards (ASTM B348-83, F136-84, F67-88) for material and design for medical application. The bone screws are of the same thread configuration and length as offered by Ace Medical, A.O. Synthes, Zimmer, Johnson & Johnson, Alphatec and many other orthopaedic companies. The minor and major diameters as well as the head size are comparable.

3950 SORRENTO VALLEY BLVD., SAN DIEGO, CALIFORNIA 92121 TELEPHONE: [phone] FACSIMILE: [phone]

{3}

KINETIKOS MEDICAL
KMI
INCORPORATED
Confidential

FDA Notification of:

## Summary of Safety and Effectiveness Information
**Product: K2 Bone Screw System™**

### Instrumentation:

KMI K2 Bone Screw System™ instrumentation used for the preparation and insertion of the K2 Bone Screws is considered to be general orthopaedic instrumentation. The system includes standard manual orthopaedic surgical instruments of the appropriate size and type. All K2 System instruments are manufactured from stainless steel meeting ASTM F899-84 standards.

### Product Sterilization:

KMI will supply all instruments and implants **Non-Sterile**. Non-Sterile implants are packaged in “clean only” condition. The labeling of the implants and instruments clearly indicates their sterility status. The package insert contains a sterilization/re-sterilization guideline.

### Summary:

Substantial Equivalence for the KMI K2 Bone Screw System™ may be found in comparison with devices from a number of manufactures. Bone Screw systems in general have been used for many years, and the clinical performance is well known and documented.

Another measure of the Safety and Effectiveness of a medical device is how it performs in long term use. The basic design concept of bone screws for use in the fixation and stabilization of fractures has had over 75 years of clinical evaluation. Uses, Indications, limitations and surgical techniques are well understood. Standardized manufacturing methods, design practices, material selections and testing techniques are known and represented within the guidelines of this submittal.

3950 SORRENTO VALLEY BLVD., SAN DIEGO, CALIFORNIA 92121 TELEPHONE: [phone] FACSIMILE: [phone]