B-TWIN BONE EXPANDER SYSTEM (B-TWIN BE SYSTEM)

K032358 · Disc-O-Tech Medical Technologies, Ltd. · HRX · Dec 17, 2003 · Orthopedic

Device Facts

• Record ID: K032358
• Device Name: B-TWIN BONE EXPANDER SYSTEM (B-TWIN BE SYSTEM)
• Applicant: Disc-O-Tech Medical Technologies, Ltd.
• Product Code: HRX · Orthopedic
• Decision Date: Dec 17, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.1100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The B-Twin BE System is intended for use as 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

B-Twin Bone Expander System is a mechanical surgical instrument used for bone tamp procedures. It consists of an expandable tube mounted on a delivery system and an instrumentation set. The device is inserted into cancellous bone in a reduced 5-mm diameter configuration; it is then expanded within the bone to create a void or reduce fractures. Used by surgeons in clinical settings to assist in orthopedic procedures. The device provides a physical means to manipulate bone structure, aiding in fracture management and bone void creation.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design, material, and technological characteristics compared to predicate devices.

Technological Characteristics

Mechanical bone tamp system. Components include an expandable tube and delivery system. Materials include polymeric tubes. Device is a manual surgical instrument. No electronic, software, or energy-based components.

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

• KyphX Inflatable Bone Tamp (K981251, K010246)
• Fixion Interlocking Proximal Femoral Intramedullary Nailing System (K010988, K012967, K023437)

Submission Summary (Full Text)

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# 032356

# DEC 1 7 2003

Disc-O-Tech Medical Technologies, Ltd. B-Twin BE System 510(k)

# 510(K) Summary

# Disc-O-Tech Medical Technologies Ltd.

## B-Twin 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

July 2003

### Trade/Proprietary Name

B-Twin Bone Expander System (B-Twin BE System)

#### Classification

Class II

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#### Predicate Devices

- V KyphX Inflatable Bone Tamp (K981251, K010246), by Kyphon Inc.
- V Fixion Interlocking Proximal Femoral Intramedullary Nailing System (K010988, K012967, K023437) by Disc-O-Tech Medical Technologies, Ltd.

#### Intended Use

The B-Twin BE System is intended for use as 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 B-Twin BE 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 B-Twin BE System intended use, design, material, technological characteristics and principles of operation are substantially equivalent to those of Kyphon's KyphX Inflatable Bone Tamp (K981251, K010246). In addition, with respect to certain issues like sterilization, equivalence is claimed to the different Fixion Intramedullary Nailing Systems (e.g., the Fixion PF - K010988, K012967, K023437). Expandable Tube material equivalence is claimed to polymeric tubes for medical applications.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized depiction of an eagle with three stripes extending from its wing.

DEC 1 7 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Disc-O-Tech Medical Technologies Ltd. c/o Mr. Jonathan S. Kahan, Esq. Hogan & Hartson L.L.P. 555 Thirteenth Street, NW Washington, D.C. 20004-1109

Re: K032358

Trade/Device Name: B-Twin Bone Expander System (B-Twin BE 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: October 3, 2003 Received: October 3, 2003

Dear Mr. Kahan:

We have reviewed your Section 510(k) premarket notification of intent to market the device w o nave review four be 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 10 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 complics 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. Jonathan S. Kahan, Esq.

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,

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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# INDICATIONS FOR USE

510(k) Number (if known): K032358

Device Name:

B-Twin Bone Expander System (B-Twin BE System)

Indications For Use:

The B-Twin Bone Expander System (B-Twin BE 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 _____________________________________________________________________________________________________________________________________________________________ V (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

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

510(k) Number K032358

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