KOMPRESSOR SCREW SYSTEM

K040356 · Kinetikos Medical, Inc. · HWC · Mar 1, 2004 · Orthopedic

Device Facts

• Record ID: K040356
• Device Name: KOMPRESSOR SCREW SYSTEM
• Applicant: Kinetikos Medical, Inc.
• Product Code: HWC · Orthopedic
• Decision Date: Mar 1, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The use of the Kompressor compression screw is generally indicated for the reduction and fixation of fractures appropriate for the size of the device. It is indicated for use in the internal fixation of fractures, fusion, and revision. It is also indicated for reconstructive procedures where reduction and fixation of bone fragments is required (e.g. osteotomies). Contraindications would include any conditions which would contraindicate implants in general, including: - Infection - Metal sensitivity or allergic reaction to foreign bodies - Any concomitant disease which may compromise the function of the implant - In those cases where avascular necrosis has rendered bone stock inadequate

Device Story

Two-piece bone screw implant; leading and trailing screw components; utilizes varying thread pitch to draw bone segments together; facilitates reduction and internal fixation of small bone fractures; used in clinical settings by surgeons; provides mechanical stabilization of bone fragments; benefits patient through improved fracture healing and bone reconstruction.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Titanium alloy (Ti-6Al4V-ELI per ASTM F136); two-piece screw design; mechanical compression via varying thread pitch; non-powered; manual surgical instrumentation.

Indications for Use

Indicated for reduction and internal fixation of fractures, fusion, revision, and reconstructive procedures (e.g., osteotomies) appropriate for device size. Contraindications: infection, metal sensitivity, concomitant disease compromising implant function, or avascular necrosis with inadequate bone stock.

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

• KMI Kompressor compression screw (K024233)

Submission Summary (Full Text)

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MAR - 1 2004

Modified KMI Kompressor Compression Screw System

For

- 1. Submitter:
Kinetikos Medical, Inc. Suite 180 6005 Hidden Valley Rd. Carlsbad, CA 92009

# Contact Person:

K040356
page 1 of 1

John G. Spampinato V.P., Quality Assurance Kinetikos Medical, Inc. Suite 180 6005 Hidden Valley Road Carlsbad, CA 92009 FAX [phone] [phone]

Date Prepared: Feb 10, 2004

| 2. Trade Name: | Kompressor Compression Screw System |
|----------------------|-------------------------------------|
| Common Name: | Compression Screw |
| Classification Name: | Orthopedic |

# 3. Predicate or legally marketed devices which are substantially equivalent

-KMI Kompressor compression screw (K024233)

#### Description of Device 4.

Description of Device
The Kompressor bone screw implant is a two-picce fixation device intended for use in the reduction, stabilization, and internal fixation of small bone fractures. The 2-picce design icaucilon, stabilization, and trailing screw component. The implant utilizes a mouporates the use of a reading and trailing portions of the screw to reduce and variance in thread phen between and le in a variety of sizes to accommodate various fracture types and sites.

Materials: Titanium; Ti-6A14V-ELI per ASTM F136 Materials: The system functions to draw bone fractures together, thereby facilitating fixation.

### 5. Intended Use

The use of the Kompressor compression screw is generally indicated for the reduction and The use of the Rompressor vempression is is indicated for use in the internal fixation of fractures appropriate for the Silso indicated for reconstructive procedures where reduction and fixation of bone fragments is required (e.g. osteotomies). Contraindications would include any conditions which would contraindicate implants in general, including:

- Infection ◆
- Metal sensitivity or allergic reaction to forcign bodies .
- Mour concomitant disease which may compromise the function of the implant .
- In those cases where avascular necrosis has rendered bone stock inadequate .

### Comparison of technological characteristics of the device to predicate and legally 6. marketed devices:

There are no significant differences between the modified Kompression Screw There are no sigmineant arreters systems currently being marketed which would adversely and the product. The modified Kompressor compression screw system employs affect the use of the produce. The predicate, legally marketed device in that the essential the same mechanical leatures as the preasurios tegared and a trailing thread, the varying ratios contiguration consists of a leading, son tapping may and bone segments. Changes were limited to: a new range of sizes and the indications for use have been broadened to include applications other than small bones of the hand and wrist.

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Image /page/1/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three human figures.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 1 2004

Mr. John Spampinato Vice President, Quality Assurance Kinetikos Medical, Inc. 6005 Hidden Valley Road, Suite 180 Carlsbad, California 92009

Re: K040356

Trade/Device Name: Kompressor Compression Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: February 10, 2004 Received: February 17, 2004

Dear Mr. Spampinato:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. John Spampinato

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

iriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Special 510(k) Notification - - Kompressor Compression Screw System

K040356

Device Name: Kompressor Compression Screw System

Indications for Use:

The use of the Kompressor compression screw is generally indicated for the reduction and fixation of fractures appropriate for the size of the device. It is indicated for use in the internal fixation of fractures, fusion, and revision. It is also indicated for reconstructive procedures where reduction and fixation of bone Iraleatou is required (e.g. osteotomies). Contraindications would (Aclude any conditions which would contraindicate implants in general, inclucing:

- Infection .
- Metal sensitivity or allergic reaction to foreign bodies J
- Any concomitant disease which may compromise the function of the ● imolant
- In those cases where avascular necrosis has rendered bone stock . inadequate

(PLEASE DO NOT WRITE BELOW THIS LINE - CONITINUE ON ANOTHER P. GE IF NECESSARY) Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | <div> <span>X</span> </div> |
|----------------------|-----------------------------------|
| | Miriam C. Provost |
| | (Division Sign-Off) |
| | Division of General, Restorative, |
| Over-the-Counter Use | __________ |

and Neurological Devices

**510(k) Number** K040356