T2 FEMORAL NAIL

K081152 · Howmedica Osteonics Corp. · HSB · Jun 10, 2008 · Orthopedic

Device Facts

• Record ID: K081152
• Device Name: T2 FEMORAL NAIL
• Applicant: Howmedica Osteonics Corp.
• Product Code: HSB · Orthopedic
• Decision Date: Jun 10, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The T2™ Femoral Nail System is a fracture fixations device comprised of femoral nails and the related locking screws, compression screws, and end caps. The T2™ Femoral Nail System is intended to provide strong and stable internal fracture fixation with minimal soft tissue irritation. This device is utilized as an aid to healing, not as a substitute for normal intact bone and tissue.

Device Story

T2™ Femoral Nail is a line extension to existing T2™ Femoral Nail System; provides internal fracture fixation for femur. System includes femoral nails, locking screws, compression screws, and end caps. Used by orthopedic surgeons in clinical/surgical settings to stabilize fractures, aid healing, and minimize soft tissue irritation. Device acts as mechanical support for bone; does not replace normal bone/tissue. Substantial equivalence established via engineering analysis comparing strength to predicate components.

Clinical Evidence

No clinical data. Substantial equivalence is supported by engineering analysis demonstrating comparable strength to predicate devices.

Technological Characteristics

Intramedullary fixation rod system consisting of femoral nails, locking screws, compression screws, and end caps. Designed for internal fracture fixation. Mechanical device; no software or energy source.

Indications for Use

Indicated for long bone fracture fixation, specifically femoral fracture fixation, including open/closed femoral fractures, pseudoarthrosis, correction osteotomy, pathologic/impending pathologic fractures, tumor resections, supracondylar fractures with intra-articular extension, ipsilateral femur fractures, fractures proximal to total knee arthroplasty, fractures distal to hip joint, nonunions, and malunions.

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

• T2™ Femoral Nail System (K081152)

Submission Summary (Full Text)

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K081/52 pg 1 of 2

# Summary of Safety and Effectiveness Line Extension to theT2™ Femoral Nail

JUN 1 0 2008

| Proprietary Name: | T2TM Femoral Nail |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Intramedullary Nail, Femoral Nail |
| Classification Name and<br>Reference: | Intramedullary Fixation Rod and<br>accessories, 21 CFR §888.3020 |
| Device Product Code: | 87 HSB |
| For Information Contact: | Danielle Hillman, Regulatory Affairs Associate<br>Howmedica Osteonics Corp.<br>325 Corporate Drive<br>Mahwah, NJ 07430<br>Phone: [phone]<br>Fax: [phone] |
| Date Summary Prepared: | April 22, 2008 |

#### Description:

The T2™ Femoral Nail is a line extension to the T2™ Femoral Nail System. The T2TM Femoral Nail, in combination with the accessories from the predicate T2™ Femoral Nail Systems, is designed to treat various types of fractures of the femur.

### Intended Use:

The modifications do not alter the intended use of the predicate system as cleared in the referenced premarket notifications. The T2™ Femoral Nail System is a fracture fixations device comprised of femoral nails and the related locking screws, compression screws, and end caps. The T2™ Femoral Nail System is intended to provide strong and stable internal fracture fixation with minimal soft tissue irritation. This device is utilized as an aid to healing, not as a substitute for normal intact bone and tissue.

#### Indications for Use:

The T2™ Femoral Nail is indicated for long bone fracture fixation specifically femoral fracture fixation, which may include the following:

- Open and closed femoral fractures .

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# 108 1124

- Pseudoarthrosis and correction osteotomy .
- Pathologic fractures, impending pathologic fractures, and tumor resections ●
- Supracondylar fractures, including those with intra-articular extension .
- Ipsilateral femur fractures .
- Fractures proximal to a total knee arthroplasty .
- Fractures distal to hip joint ●
- Nonunions and malunions .

## Substantial Equivalence:

The subject T2™ Femoral Nail shares the same intended use and design concepts as that of the currently available T2™ Femoral Nail System. An engineering analysis demonstrated comparable strengths to the predicate components and is substantially equivalent to these devices.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 0 2008

Howmedica Osteonics Corp. % Ms. Danielle Hillman Regulatory Affairs Associate 325 Corporate Drive Mahwah, New Jersey 07430

Re: K081152 Trade/Device Name: T2™ Femoral Nail Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: June 2, 2008 Received: June 4, 2008

Dear Ms. Hillman:

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 - Ms. Danielle Hillman

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biomctric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Mark M. Milken

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): KOSIIS A

Device Name: T2TM Femoral Nail

Indications for Use:

The T2™ Femoral Nail is indicated for long bone fracture fixation specifically femoral fracture fixation, which may include the following:

- Open and closed femoral fractures .
- Pseudoarthrosis and correction osteotomy �
- . Pathologic fractures, impending pathologic fractures, and tumor resections
- Supracondylar fractures, including those with intra-articular extension .
- Ipsilateral femur fractures .
- Fractures proximal to a total knee arthroplasty .
- . Fractures distal to hip joint
- . Nonunions and malunions

Nulke del Lvs mkm
(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

K081152 510(k) Number_

Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)