SKY BONE EXPANDER SYSTEM (SKY SYSTEM)

K040939 · Disc-O-Tech Medical Technologies, Ltd. · HRX · May 12, 2004 · Orthopedic

Device Facts

• Record ID: K040939
• Device Name: SKY BONE EXPANDER SYSTEM (SKY SYSTEM)
• Applicant: Disc-O-Tech Medical Technologies, Ltd.
• Product Code: HRX · Orthopedic
• Decision Date: May 12, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.1100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SKy System is intended for use as a conventional bone tamp for the reduction of fractures and/or creation of a void in cancellous bone in the spine, hand, tibia, radius and calcaneus.

Device Story

SKy Bone Expander System functions as a mechanical bone tamp for orthopedic surgical procedures. Device consists of an expandable tube mounted on a delivery system and an instrumentation set. Surgeon inserts the tube into cancellous bone in a reduced-diameter configuration; tube is then expanded within the bone to reduce fractures or create a void. Device is used in clinical settings by physicians. Output is the physical expansion of the tube to manipulate bone structure. Benefits include minimally invasive access to bone for fracture reduction or void creation.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mechanical bone tamp system. Components include an expandable tube, delivery system, and instrumentation set. Operates via mechanical expansion of the tube within cancellous bone. Sterilization method and materials are identical to the predicate device.

Indications for Use

Indicated for patients requiring fracture reduction or void creation in cancellous bone of the spine, hand, tibia, radius, and calcaneus.

Regulatory Classification

Identification

An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.

Predicate Devices

• B-Twin Bone Expander System (K032358)
• SKy Bone Expander System (K034037)
• KyphX Inflatable Bone Tamp (K981251, K010246, K032212)

Submission Summary (Full Text)

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#### MAY 1 2 2004 510(K) Summary

# Disc-O-Tech Medical Technologies Ltd. SKy Bone Expander System

#### Company Name

Disc-O-Tech Medical Technologies, Ltd. 3 Hasadnaot St. Herzliya 46728 Israel

# Submitter's Name and Contact Person

Yael Rubin Disc-O-Tech Medical Technologics, Ltd. 3 Hasadnaot St., Herzliya 46728, Israel Tel: [phone], Fax: [phone]

### Date Prepared

April 2004

## Trade/Proprietary Name

SKy Bone Expander System (SKy System)

#### Classification

Class II

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#### Predicatc Devices

- V B-Twin Bone Expander System (K032358), by Disc-O-Tech Medical Technologics Ltd.
:

- V SKy Bone Expander System (K034037), by Disc-O-Tech Medical Technologies Ltd.
- ✔ KyphX Inflatable Bone Tamp (K981251, K010246, K032212), by Kyphon Inc.

#### Intended Use

The SKy System is intended for use as a conventional bone tamp for the reduction of fractures and/or creation of a void in cancellous bone in the spine, hand, tibia, radius and calcaneus.

#### System Description

The SKy System consists of the following components:

- ✓ Expandable Tube a tube-like component, mounted on a delivery system. Inserted into the bone in reduced diameter configuration and expanded within the bone.
- V Delivery System used for the insertion, expansion, and retrieval of the expandable tube.
- V Instrumentation Set a set of accessories to assist in insertion and location of the device.

#### Substantial Equivalence

The modified SKy System has the following similarities to the SKy System that previously received 510(k) concurrence:

- ✓
- Has the same operating principles >
- Incorporate the same design principles >
- Incorporate the same materials >
- Has the same packaging, using the same materials and processes.
- Has the same sterilization method, maintaining the same SAL. >

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services (HHS) in the USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 2 2004

Ms. Yael Rubin Director of Regulatory Affairs Disc-O-Tech Medical Technologies Ltd. 3 Hasadnaot Street Herzliya 46728 Isracl

Re: K040939

Trade/Device Name: SKy Bone Expander System (SKy System) Regulation Number: 21 CFR 888.1100; 21 CFR 888.4540 Regulation Name: Arthroscope, Orthopedic manual surgical instrument Regulatory Class: II Product Code: HRX, HXG Dated: April 8, 2004 Received: April 12, 2004

Dear Ms. Rubin:

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 cither 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 (OS) 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 - Ms. Yael Rubin

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,

Muriam 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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# Indication for Use

510(K) Number (if known):

SKy Bone Expander System (SKy System) Device Name:

Indication for Use:

The SKy Bone Expander System is intended for use as a conventional bone tamp for the reduction of fractures and/or creation of a void in cancellous bone in the spine, hand, tibia, radius and calcaneus.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

(Part 21 CFR 801 Subpart C)

Over-The-Counter Use

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Musican C. Provost

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number Ko40939 ---