TITANIUM TELEGRAPH HUMERAL NAIL

K042332 · Fournitures Hospitalieres Industrie · HSB · Oct 7, 2004 · Orthopedic

Device Facts

• Record ID: K042332
• Device Name: TITANIUM TELEGRAPH HUMERAL NAIL
• Applicant: Fournitures Hospitalieres Industrie
• Product Code: HSB · Orthopedic
• Decision Date: Oct 7, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The titanium Telegraph® humeral nail is indicated for fractures of the upper extremity and/or the diaphysis of the humerus.

Device Story

Titanium Telegraph® Humeral Nail is an intramedullary fixation rod used for humeral fractures. Device consists of short (150mm) and long (210-310mm) cylindrical nails in 7, 8, 9, and 10mm diameters, used with 4mm diameter titanium cancellous screws. Supplied sterile via gamma radiation. Intended for surgical use by physicians for internal fixation of bone fractures. Provides mechanical stability to the humerus during healing. Device is a material modification of a stainless steel predicate, utilizing titanium alloy to maintain structural integrity and biocompatibility.

Clinical Evidence

Bench testing only. Mechanical performance validated via flexion and torsion tests on 6 titanium nails (Ø7mm, 310mm length) in accordance with ASTM F 1264-00 and FDA guidance for intramedullary rods. Results confirmed compliance with mechanical resistance requirements.

Technological Characteristics

Intramedullary fixation rod; material: titanium alloy (ISO 5832/3, ASTM F-136); cylindrical geometry; diameters 7-10mm; lengths 150-310mm; interlocking via proximal self-stable screws and distal frontal plane screws; sterile (gamma).

Indications for Use

Indicated for patients with fractures of the upper extremity and/or the diaphysis of the humerus.

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

• Telegraph® humeral nail (K033510)

Submission Summary (Full Text)

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6. rue Nobel Z.I. DE KERNÉVEZ 29000 QUIMPER

FRANCE

Tél : [phone]

Fax : [phone]

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K 042372

OCT 7 - 2004

## 510 (K) SUMMARY OF SAFETY AND EFFECTIVENESS TITANIUM TELEGRAPH® HUMERAL NAIL

SPONSOR IDENTIFICATION: Fournitures Hospitalières Industrie 6 Rue Nobel, Z.I. de Kernevez 29000 QUIMPER - FRANCE Tel: [phone] Fax: [phone]

## ESTABLISHMENT REGISTRATION NUMBER: 3003898228

OFFICIAL CONTACT PERSON: Christine QUENDEZ Regulatory Affairs Manager E-mail: [e-mail]

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DEVICE TRADE NAME: COMMON NAME: Intramedullary rod REGULATORY CLASS: Class II

DEVICE PRODUCT CODE:

DATE PREPARED:

PANEL CODE:

TITANIUM TELEGRAPH® HUMERAL NAIL 87 HSB 21 CFR 888.3020

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### DEVICE DESCRIPTION:

The titanium Telegraph® humeral nails are made of titanium and are available in two models :

AUGUST 23th, 2004

- a short humeral nail (150mm length)
- a long humeral nail (from 210 to 310mm).

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- These two models are available in four diameters: 7, 8, 9 and 10mm. These titanium humeral nails are intended to be used with titanium cancellous screws, available in 15 lengths (from 24 to 50mm) and with a 4mm diameter. The titanium Telegraph® humeral nail and the screws are supplied sterile.
#### INDICATIONS FOR USE:

The titanium Telegraph® humeral nail is indicated for fractures of the upper extremity and/or the diaphysis of the humerus.

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## PREDICATE DEVICES:

The titanium Telegraph® humeral nail is similar to the Telegraph® humeral nail previously cleared in K033510.

## COMPARISON OF TECHNOLOGICAL CHARACTERISTICS:

The proposed titanium Telegraph nails have the same intended use and indications for use as the predicate device. Design and manufacturing process is the same.

The only difference is the modification of the material. The proposed devices are made of titanium alloy according to ISO 5832/3 and ASTM F-136 standards. Performance tests were performed. Our proposed devices and the predicate devices were found to have results in compliance with the selected standard.

| | Titanium Telegraph® Humeral nail | Telegraph® Humeral nail |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | F.H.I | F.H.I |
| 510 K number | Pending | K033510 |
| Intended use | Intended for fractures of the upper extremity<br>and/or the diaphysis of the humerus. | Intended for use for proximal and/or<br>diaphyseal fractures of the humerus. |
| Material | Titanium alloy | Stainless steel |
| Cylindrical | Yes | Yes |
| Sizes<br>Diameter<br>Length | Ø 7, 8, 9 and 10 mm<br>Short nail: 150 mm<br>Long nail: 210, 230, 250, 270, 290, 310 mm | Ø 7, 8 and 9 mm<br>Short nail: 150 mm<br>Long nail: 210, 230, 250, 270, 290, 310 mm |
| Interlocking<br>screws | Proximal: 3 self-stable screws<br>Distal: 2 screws in the frontal plane | Proximal: 3 self-stable screws<br>Distal: 2 screws in the frontal plane |
| Performance<br>tests | Flexion tests on 6 Titanium nail Ø7 and<br>310mm length,<br>Torsion tests on 6 Titanium nail Ø7 and<br>310mm length.<br>(according to ASTM F 1264-00) | Flexion tests on 6 Titanium nail Ø7 and<br>310mm length,<br>Torsion tests on 6 Titanium nail Ø7 and<br>310mm length.<br>(according to ASTM F 1264-00) |
| Sterile | Yes (Gamma) | Yes (Gamma) |

The following comparative table is provided to further demonstrate equivalence:

#### PERFORMANCES:

। -

Performance testing was performed in accordance with the recommendations set up in the FDA guidance document "Reviewers Guidance Checklist for Intramedullary Rods". The following tests were performed to validate the mechanical characteristics of the Titanium Telegraph humeral nail (according to ASTM F 1264-00 standard):

- Flexion test on 6 titanium Telegraph humeral nail
- Torsion test on 6 titanium Telegraph humeral nail

All results demonstrate that the proposed device is in accordance with the mechanical resistances required by the ASTM F 1264-00 standard.

#### CONCLUSION:

All these elements show the safety and effectiveness of our product. Our titanium Telegraph humeral nails are substantially equivalents to the Telegraph humeral nail cleared in K033510 in terms of intended use, design, safety and effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 7 - 2004

Christine Quendez Regulatory Affairs Manager Fournitures Hospitalieres Industrie 6 Rue Nobel, Z.I. de Kernevez 29000 Quimper-France

Re: K042332

Trade/Device Name: Titanium TELEGRAPH® Humeral Nail Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: August 23, 2004 Received: August 30, 2004

Dear: Ms Quendez

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 - Christine Quendez

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,

Mark N. Mikkelsen

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):

K042332

Device Name:

Titanium TELEGRAPH® Humeral Nail

Indications for Use:

The TELEGRAPH® Humeral Nail is indicated for fractures of the upper extremity and/or the diaphysis of the humerus.

Mark A. Millman

Division Sign-Of Division of General, Restorative, and Neurological Devices

510(k) Number.

K042332

Prescription Use Х (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 OF NEEDED)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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