MODIFICATION TO T2 RECON NAIL SYSTEM

K083437 · Howmedica Osteonics Corp. · HSB · Dec 18, 2008 · Orthopedic

Device Facts

• Record ID: K083437
• Device Name: MODIFICATION TO T2 RECON NAIL SYSTEM
• Applicant: Howmedica Osteonics Corp.
• Product Code: HSB · Orthopedic
• Decision Date: Dec 18, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The subject 120 Recon Nail System is a fracture fixation device comprised of Femoral Nails and the related accessories such as Washers, Locking Screws, Set Screws, End Caps, and Lag Screws. The subject and predicate devices are 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 Recon Nail System is an intramedullary (IM) nail system for femoral fracture fixation. This line extension introduces an alternate set screw design. The system comprises femoral nails, washers, locking screws, set screws, end caps, and lag screws. Used by orthopedic surgeons in clinical settings to provide internal fracture fixation, the device acts as an aid to healing for bone fractures. It does not replace intact bone. The device is implanted surgically to stabilize fractures, reducing soft tissue irritation and promoting bone healing.

Clinical Evidence

Bench testing only.

Technological Characteristics

Materials: Titanium alloy and PEEK. Components: Intramedullary nail, washers, locking screws, set screws, end caps, lag screws. Design: Line extension of existing T2 Recon Nail System. Mechanical/functional properties verified via bench testing.

Indications for Use

Indicated for fixation of subtrochanteric, intertrochanteric, ipsilateral neck/shaft, and comminuted proximal femoral shaft fractures; femoral fixation for pathological disease; and temporary stabilization of femoral shaft fractures from the femoral neck to the supracondylar region.

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.

Submission Summary (Full Text)

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# DEC 1 8 2008

Special 510(k)

K083437

/ .

### 510(k) Summary of Safety and Effectiveness: T2® Recon Nail System Line Extension

#### Submission Information

Name and Address of the Sponsor of the 510(k) Submission:

For Information contact:

Howmedica Osteonics Corp 325 Corporate Drive Mahwah, NJ 07430

Avital Merl-Margulies, Regulatory Affairs Associate Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 Phone: [phone] Fax: [phone]

Date Summary Prepared:

November 10, 2008

## Device Identification

Proprietary Name: Common Name: Classification Name and Reference: T2® Recon Nail System Intramedullary Nail Intramedullary Fixation Rod and Accessories, 21 CFR §888.3020 87 HSB

Device Product Codc:

## Description:

The T2® Recon Nail System is a family of IM Nails for various types of femoral fractures. This Special 510(k) submission is a line extension to the T2® Recon Nail System to add an alternate design of Set Screw to the system. There is no change in intended use for the subject device, which is provided below.

## Intended Use:

The subject 120 Recon Nail System is a fracture fixation device comprised of Femoral Nails and the related accessories such as Washers, Locking Screws, Set Screws, End Caps, and Lag Screws. The subject and predicate devices are 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® Recon Nail indications include fixation of subtrochanteric, interochanteric, ipsilateral neck/shaft, communited proximal femoral shaft fractures, femoral fixation required as a result of pathological disease, and temporary stabilization of fractures of the femoral shaft ranging from the femoral neck to the supracondylar regions of the femur.

## Statement of Technological Comparison:

The subject and prodicate devices are made from titanium alloy and PEEK. Functional and mechanical testing demonstrates the comparable mechanical & functional propertics of the subject T2® Recon Nail System to the predicate device.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/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. In the center of the circle is an abstract symbol that resembles an eagle or other bird.

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### DEC 1 8 2008

Howmedica Osteonics Corp. % Ms. Avital Merl-Margulies 325 Corporate Drive Mahwah, NJ 07430

Re: K083437

Trade/Device Name: 120 Recon Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: November 10, 2008 Received: November 20, 2008

Dear Ms. Merl-Margulies:

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. Avital Merl-Margulies

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 Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding 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 yours.

Mark H. Milliken

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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# Indications for Use

510(k) Number (if known): K083437

Device Name: T2® Recon Nail System

Indications For Use:

The T2® Recon Nail indications include fixation of subtrochanteric, interochanteric, ipsilateral neck/shaft, communited proximal femoral shaft fractures, femoral fixation required as a result of pathological disease, and temporary stabilization of fractures of the femoral shaft ranging from the femoral neck to the supracondylar regions of the femur.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

(21 CFR 807 Subpart C)

Over-The-Counter Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

ign-01 Division of General, Restorative, and Neurological Devices

10683432

510(k) Number.