FASSIRE-DUVAL TELESCOPIC IM SYSTEM

K020885 · Pega Medical, Inc. · HSB · Feb 6, 2003 · Orthopedic

Device Facts

• Record ID: K020885
• Device Name: FASSIRE-DUVAL TELESCOPIC IM SYSTEM
• Applicant: Pega Medical, Inc.
• Product Code: HSB · Orthopedic
• Decision Date: Feb 6, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

This implant is indicated as a temporary implant to aid in the healing of long diaphysis fractures, osteotomies, malunions and nonunions and to prevent further fractures in femur, tibia and humerus in pediatric patients suffering from Osteogenesis Imperfecta without disrupting the bone growth plate. It can be used in procedures such as bone lengthening concomitantly with external fixators in pediatric or small statured patients with limb length discrepancy.

Device Story

Fassier-Duval Pediatric IM System is a telescopic intramedullary nail designed for pediatric orthopedic fixation. Device consists of two sliding components: a female component anchored to the proximal cortex and a male component anchored to the distal cortex via screw-type fixation. Telescopic design allows the nail to extend in length as the patient grows, facilitating bone healing without disrupting growth plates. Used by orthopedic surgeons in clinical settings for fracture management and limb length discrepancy correction. System provides structural support to long bones; allows for natural bone growth; reduces re-operation and complication rates compared to traditional non-telescopic nails.

Clinical Evidence

Clinical data submitted comparing the Fassier-Duval system to the Dubow-Bailey Intramedullary Nail in the operative treatment of Osteogenesis Imperfecta. Results demonstrated a 3-fold reduction in re-operation rate and a 2 to 3-fold reduction in complication rate for the subject device. Preclinical bench testing performed according to ASTM F 1264 (four-point bending).

Technological Characteristics

Telescopic intramedullary nail system; two-piece sliding design (male/female components); screw-type fixation. Mechanical testing performed per ASTM F 1264 (four-point bending).

Indications for Use

Indicated for pediatric patients with Osteogenesis Imperfecta requiring temporary fixation of long bone fractures (femur, tibia, humerus), osteotomies, malunions, or nonunions, and for pediatric or small-statured patients requiring bone lengthening/shortening for limb length discrepancy. Contraindicated if growth plate disruption is required.

Regulatory Classification

Identification

An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.

Predicate Devices

• Dubow-Bailey Intramedullary Nail (pre-amendment)
• Retrograde Pediatric Nail (K980854)
• Intramedullary Fixation Rod/Pin (K971783)
• Grosse & Kempf Intramedullary Nail (K813371)

Submission Summary (Full Text)

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K020885 P i/2

Image /page/0/Picture/1 description: The image shows the logo for Pega Medical. The logo consists of the words "Pega Medical" in a sans-serif font, with "Pega" in a larger, bolder font than "Medical". Above the text is a stylized graphic of a person with curved lines emanating from their head, resembling motion or energy. The logo is in black and white.

9260 Viau Blvd. Montreal Quebec H1R 2V8

FEB 0 6 2003

phone: [phone] ax: [phone] il: pegamedical@pegamedical.c website www.pegamedical.com

Montreal, January 23, 2003

### 510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS

Contact Person: Ariel R. Dujovne, M.Sc

Pega Medical Inc. 9260 boul Viau, Montreal Ouebec. H1R 2V8 CANADA [phone] ext. 241

Proprietary Name: Fassier-Duval Pediatric IM System

Common Name: Telescopic Nail

Device Classification: Class II

Classification Name: Intramedullary fixation rod - 21CFR 888.3020/888.3030/888.3040

#### Establishment Registration Number: 9048931

Intended Use: This implant is indicated as a temporary implant to aid in the healing of long diaphysis fractures, osteotomies, malunions and nonunions and to prevent further fractures in femur, tibia and humerus in pediatric patients suffering from Osteogenesis Imperfecta without disrupting the bone growth plate. It can be used in procedures such as bone lengthening concomitantly with external fixators in pediatric or small statured patients with limb length discrepancy.

Description: The Fassier-Duval Pediatric IM System is a telescopic rod for use in fixation of long bone fractures. The design of the nail includes a female component (which is attached to the proximal -trochanteric- cortex of the bone) and a male component (which is attached to the distal cortex of the bone). Anchorage of the components is achieved through screw-type fixation. The nail is composed of two sliding components that allow for extension of its length as the bone structures heal and normal patient growth occurs. The Fassier-Duval Pediatric IM System can be attached to bony structures without disrupting the bone growth plates.

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### Basis for substantial equivalent:

The Fassier-Duval Pediatric IM System is claimed to be substantially equivalent in design and function to the following predicate devices:

- 1. Dubow-Bailey Intramedullary Nail, Zimmer, Inc. Warsaw, IN (510(k) number - Not available, pre-amendment device)
- 2. Retrograde Pediatric Nail, Encore Orthopedics, Inc., Austin, TX (K980854)
- 3. Intramdedullary Fixation Rod/Pin, Synthes (USA), Paoli, PA (K971783)
- 4. The Grosse & Kempf Intramedullary Nail, Howmedica, Rutherford, NJ (K813371)

The intended uses of these devices are the same as the Fassier-Duval Pediatric IM System.

The technological characteristics of the Fassier-Duval Pediatric IM System are identical to the ones of the Dubow-Bailey Intramedullary Nail except for the method of fixation. Clinical data submitted with the current application demonstrated that in the operative treatment of OI, the Fassier-Duval Pediatric IM System produces a 3fold reduction in the re-operation rate and a 2 to 3-fold reduction in the complication rate, compared to the predicate device #1.

For predicated devices #2, 3 and 4, substantial equivalence was demonstrated by preclinical data according to ASTM F 1264 (four point bending). Although there are several design differences with the predicate devices, they do not raise new questions of safety and effectiveness.

KO208BS

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized human figure with three faces in profile, representing health and well-being. The figure is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in capital letters.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# FEB 0 6 2003

Mr. Ariel R. Dujovne, Ing., M.Sc. Pega Medical, Inc. 9260 Viau Boulevard St-Leonard, (Montreal) Quebec. Canada H1R 2V8

Re: K020885

Trade/Device Name: Fassier Duval Telescopic IM Nail System Regulation Number: 21 CFR \$888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: December 4, 2002 Received: December 6, 2002

Dear Mr. Dujovne:

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

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Page 2 -- Mr. Ariel R. Dujovne, Ing., M.Sc.

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.

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). Other general information on your responsibilities under the Act may be obtained 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,

Mark M Millman

Celia 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 ENCLOSURE

510(k) Number (if known):

Device Name: Fassier-Duval Pediatric Intramedullary Nail System

## INDICATIONS FOR USE

This implant is indicated as a temporary implant to aid in the healing of long diaphysis fractures, osteotomies, malunions and nonunions and to prevent further fractures in femur, tibia and humerus in pediatric patients suffering from Osteogenesis Imperfecta without disrupting the bone growth plate. It can be used in procedures such as bone lengthening/shortening concomitantly with external fixators in pediatric or small stature patients with limb length discrepancy.

for Mark N. Millman

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

KO20885 10(k) Number _________________________________________________________________________________________________________________________________________________________________