SKY BONE EXPANDER SYSTEM (SKY SYSTEM)

K040612 · Disc-O-Tech Medical Technologies, Ltd. · HRX · Jun 17, 2004 · Orthopedic

Device Facts

• Record ID: K040612
• Device Name: SKY BONE EXPANDER SYSTEM (SKY SYSTEM)
• Applicant: Disc-O-Tech Medical Technologies, Ltd.
• Product Code: HRX · Orthopedic
• Decision Date: Jun 17, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.1100
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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. In the spine, it may be used in combination with polymethylmethacrylate (PMMA) bone cements that are legally marketed for use in vertebroplasty or kyphoplasty procedures.

Device Story

SKy Bone Expander System functions as a mechanical bone tamp for orthopedic 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 5-mm diameter configuration; tube is then expanded within the bone to create a void or reduce fractures. Used in spine, hand, tibia, radius, and calcaneus. In spinal applications, device facilitates subsequent delivery of PMMA bone cement for vertebroplasty or kyphoplasty. System provides mechanical assistance to surgeons during orthopedic surgery to restore bone geometry or prepare sites for cement augmentation.

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. Non-powered, manual surgical instrument.

Indications for Use

Indicated for patients requiring fracture reduction or void creation in cancellous bone of the spine, hand, tibia, radius, or calcaneus. May be used with PMMA bone cements for vertebroplasty or kyphoplasty.

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 BE System (K032358)
• SKy Bone Expander System (K034037)

Submission Summary (Full Text)

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# JUN 1 7 2004 . .

K0406/2

## 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 Israel, 46728

### Submitter's Name and Contact Person

- 1. Yael Rubin Disc-O-Tech Medical Technologies, Ltd. 3 Hasadnaot St. Herzliya, Israel, 46728 Tel: [phone], Fax: [phone]
- 2. Jonathan S. Kahan, Esq. 555 Thirteenth Street, NW, Washington, DC · · 20004 · · · · · · · · · · · · · · · · . Tel: [phone], Fax: [phone]

### Date Prepared June 2004

# Trade/Proprietary Name

SKy Bone Expander System (SKy System)

# Classification

Class II

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K040612

#### Predicate Devices

- B-Twin BE System (K032358) by Disc-O-Tech Medical Technologies, Ltd. >
- SKy Bone Expander System (K034037) by Disc-O-Tech Medical Technologies, Ltd.

### Intended 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. In the spine, it may be used in combination with polymethylmethacrylate (PMMA) bone cernents that are legally marketed for use in vertebroplasty or kyphoplasty procedures.

#### 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 5-mm diameter configuration and expanded within the bone.
- > Delivery system used for the insertion, expansion, and retrieval of the expandable tube.
- > Instrumentation Set - a set of accessories to assist in insertion and location of the device.

#### Substantial Equivalence

In general, the SKy System intended use, design, materials, technological characteristics and principles of operation are substantially equivalent to those of currently cleared B-Twin BE and SKy Systems (K032358, K034037).

the submit and the submit of the submit of the submit of the subject of

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with three horizontal bars extending from its body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 7 2004

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

Re: K040612

Ro40012
Trade/Device Name: Sky Bone Expander System (Sky System) Trade/DOTICO Number: 21 CFR 888.1100, 21 CFR 888.4540 Regulation Name: Arthroscope; Orthopedic manual surgical instrument Regulatory Class: II Product Code: HRX, HXG Dated: March 4, 2004 Received: March 24, 2004

Dear Ms. Rubin:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection 910(t) premier is substantially equivalent (for the indications felerenced above and nave determined on and and and one inces marketed in interstate for use stated in the cherosure to regally many a program and the Medical Device Amendments, or to comments provision to May 20, 7978, in economice with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA). and Costience Act (Act) that do not require subject to the general controls provisions of the Act. The r ou may, merclore, market the device, est include requirements for annual registration, listing of general controls provisions of ractice, 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 If your device is classified (600 we 10, 2017 and on regulations affecting your device can
may be subject to such additional controls. Existing major and contribution FD to may be subject to subli additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Ood of I casse concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Picase be advised that 117A : 15suarce of a succession ...
that FDA has made a determination that your device complies with other requirements of the Act that I DA has made a determinations administered by other Federal agencies. You must of ally it catal statutes and regations and limited to: registration and listing (21 comply with an the 7tet 37equirements)01); good manufacturing practice requirements as set CTN i at 807), idocinig (21 OFR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin maneting your and equivalence of your device to a legally premarket notification. The PDA mianing of castom.
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 If you desire specific advice for your ac 11.000. 4659. Also, please note the regulation entitled, comact the Office of Complance in (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational 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,

Miriam 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

KO40612 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 The biry Done and/or creation of a void in cancellous bone in the spine, hand, tibia, radius and calcaneus. In the spine, it may be used in combination with polymethacrylate (PMMA) bone cements that are legally marketed for use in vertebroplasty or kyphoplasty procedures.

Over-The-Counter Use AND/OR Prescription Use _ (Part 21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

Division of General, Restorative. and Neurological Devices

**510(k) Number** K040612

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