T2 FEMORAL NAIL

K021744 · Howmedica Osteonics Corp. · HSB · Jun 26, 2002 · Orthopedic

Device Facts

• Record ID: K021744
• Device Name: T2 FEMORAL NAIL
• Applicant: Howmedica Osteonics Corp.
• Product Code: HSB · Orthopedic
• Decision Date: Jun 26, 2002
• 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 fixation 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 cylindrical, cannulated titanium alloy tube used for internal fracture fixation. Device is inserted into femoral canal via retrograde or antegrade surgical approach to provide stable fixation. Modification adds shorter nail lengths (140 mm and 160 mm) without anterior bow. Device is used by orthopedic surgeons in clinical/surgical settings. Output is mechanical stabilization of bone fractures, aiding healing process. Benefits include strong, stable fixation with minimal soft tissue irritation.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Cylindrical, cannulated titanium alloy tube. Available in diameters 9-15 mm; lengths 140-480 mm. Shorter versions (140/160 mm) lack anterior bow. Mechanical fixation device; no software or energy source.

Indications for Use

Indicated for long bone fracture fixation, specifically femoral fracture fixation, including open and closed femoral fractures, pseudoarthrosis, correction osteotomy, pathologic fractures, impending pathologic fractures, tumor resections, supracondylar fractures (including intra-articular extension), ipsilateral femur fractures, fractures proximal to total knee arthroplasty, fractures distal to a 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 (K021744)

Submission Summary (Full Text)

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JUN 2 6 2002

# Special 510(k) Summary: Line Extension to theT2 Fen

#### Submission Information

| Name and Address of the Sponsor<br>of the 510(k) Submission: | Howmedica Osteonics Corp<br>59 Route 17<br>Allendale, NJ 07401-1677 |
|--------------------------------------------------------------|---------------------------------------------------------------------|
| Contact Person: | Karen Ariemma<br>Regulatory Affairs Specialist |
| Date of Summary Preparation: | May 24, 2002 |
| Device Identification | |
| Proprietary Name: | T2 Femoral Nail |
| Common Name: | Intramedullary Nail, Femoral Nail |
| Classification Name and Reference: | Intramedullary Fixation Rod, 21 CFR §888.3020 |

### Predicate Device Identification

The T2 Femoral nail is a cylindrical, cannulated titanium alloy tube, slightly bowed to accommodate the shape of the femur. The T2 Femoral Nail may be inserted into the femoral canal using either a retrograde or antegrade surgical approach. The T2 Femoral Nail is available in diameters ranging from 9 to 15 mm and lengths ranging from 180 to 480 mm.

# Description of Device Modification

The line extension involves the addition of two shorter nail lengths, 140 and 160 mm, throughout the entire diameter range. These shorter femoral nails do not have an anterior bow.

#### Intended Use

The T2 Femoral Nail System is a fracture fixation 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.

# Statement of Technological Comparison:

The design and function of the shorter T2 Femoral Nail are substantially equivalent to that of the predicate device.

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JUN 2 6 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Karen Ariemma Regulatory Affairs Howmedica Osteonics Corporation 59 Route 17 Allendale, NJ 07401-1677

Re: K021744

Trade/Device Name: T2™ Femoral Nail System Regulation Number: 888.3020 Regulation Name: Inramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: May 24, 2002 Received: May 28, 2002

Dear Ms. Ariemma:

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. Karen Ariemma

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, 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,

Sincerely yours,

lo Mark N Millenm

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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510(k) Number (if known): K OQ 1744

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Device Name: T2™ Femoral Nail System

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 a hip joint .
- Nonunions and malunions .

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _____________________________________________________________________________________________________________________________________________________________

OR

Over-The-Counter Use

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

for

(Division Sig)
Division of General, Restorative
and Neurological Devices

510(k) Number K021744