OSTEO IC FEMORAL AND TIBIAL NAILS AND OSTEO RETROGRADE/ANTEGRADE FEMORAL NAILS WITH T2 LOCKING SCREWS

K011622 · Howmedica Osteonics Corp. · HSB · Jun 15, 2001 · Orthopedic

Device Facts

• Record ID: K011622
• Device Name: OSTEO IC FEMORAL AND TIBIAL NAILS AND OSTEO RETROGRADE/ANTEGRADE FEMORAL NAILS WITH T2 LOCKING SCREWS
• Applicant: Howmedica Osteonics Corp.
• Product Code: HSB · Orthopedic
• Decision Date: Jun 15, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The T2 Locking Screws continue to be intended for single use only. They are intended for use with the predicate Osteo IC Femoral/Tibial Nail and Osteo R/A Nail Systems and, when used with these nail systems, are subject to their specific indications.

Device Story

T2 Locking Screws are orthopedic fixation components used in conjunction with Osteo IC Femoral/Tibial Nails and Osteo R/A Femoral Nails. The device is a mechanical screw used by orthopedic surgeons in a clinical/surgical setting to secure intramedullary nails within long bones. The screws provide structural stability for fracture fixation. No changes were made to the screw design or materials; the submission serves to authorize the cross-compatibility of existing predicate T2 screws with existing predicate Osteo nail systems. The healthcare provider uses the screws during surgical procedures to stabilize bone fractures, facilitating healing and patient recovery.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Mechanical orthopedic locking screws. Materials are identical to previously cleared T2 Locking Screws. Dimensions: 5.0mm diameter. Intended for single use. No software or electronic components.

Indications for Use

Indicated for patients with open/closed femoral and tibial shaft fractures, pseudoarthrosis, correction osteotomies, pathologic fractures, tumor resections, and change of procedure following external fixation. When used with Osteo R/A Femoral Nails, also indicated for supracondylar fractures, ipsilateral femur fractures, fractures proximal to total knee arthroplasty, fractures distal to hip implants, 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

• Osteo IC Femoral and Tibial Nails (K992063)
• Osteo Retrograde/Antegrade (R/A) Femoral Nails (K982601)
• T2 Femoral Nails (K010801)
• T2 Tibial Nails (K003018)

Submission Summary (Full Text)

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KOII622

Special 510(k) Premarket Notification

# JUN 1 5 2001

### 510(k) Summary: T2 Locking Screws - Use with Osteo Femoral and Tibial Nails

#### 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, 2001 |
| <b>Device Identification</b> | |
| Proprietary Name: | Osteo IC Femoral and Tibial Nails and Osteo<br>Retrograde/Antegrade Femoral Nails with T2<br>Locking Screws |
| Common Name: | Intramedullary Nails |

Classification Name and Reference: Intramedullary Fixation Rod, 21 CFR §888.3020

#### Predicate Device Identification

The Osteo IC Femoral and Tibial Nails (K992063) and Osteo Retrograde/Antegrade (R/A) Femoral Nails (K982601) have been determined Substantially Equivalent when used with associated Osteo IC 5.0mm diameter Locking Screws. The T2 Femoral Nails (K010801) and T2 Tibial Nails (K003018) have also been determined Substantially Equivalent when used with associated T2 5.0mm diameter Locking Screws. This submission is intended to allow use of the predicate 5.0mm diameter T2 Locking Screws with the predicate Osteo IC Femoral/Tibial Nails and Osteo R/A Femoral Nails.

#### Description of Device Modification

This submission involves no change to the components themselves. This submission covers use of predicate T2 Locking Screws with predicate Osteo IC Femoral/Tibial Nail and Osteo R/A Femoral Nail Systems.

#### Intended Use

The T2 Locking Screws continue to be intended for single use only. They are intended for use with the predicate Osteo IC Femoral/Tibial Nail and Osteo R/A Nail Systems and, when used with these nail systems, are subject to their specific indications.

#### Statement of Technological Comparison:

The T2 Locking Screws are identical in materials and are similar in design to the associated locking screws originally cleared for use with the specified Osteo Nail Systems. Engineering analysis and testing have shown that the T2 Locking Screws are similar enough to the Osteo Locking Screws to be safely used with the associated Osteo IC Femoral/Tibial Nail and Osteo R/A Femoral Nail Systems

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Image /page/1/Picture/12 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with text around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 5 2001

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

Re: K011622

Trade Name: Osteo IC Femoral and Tibial Nails and Osteo Retrograde/Antegrade Regulatory Number: 888.3020 Regulatory Class: II Product Code: HSB Dated: May 24, 2001 Received: May 25, 2001

Dear Ms. Ariemma:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the stared in the encere) to the Medical Device Amendments, or to devices that have been reclassified in charentions with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general thorolo, mainer and 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good 099. I subblaing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to mopolionist the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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.

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Page 2 - Ms. Karen Ariemma

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at additionally 607.10 for in 1189 angliestions on the promotion and advertising of your device, (2017) 594-1037. Traditionally, for quice at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small mormation on your responsiving the number [phone] or at [phone], or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Signature

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 △//622

# Device Name: T2 Locking Screws - Use with Osteo Femoral and Tibial Nails

The T2 Locking Screws continue to be intended for single use only. They are intended for use with the predicate Osteo IC Femoral/Tibial Nail and Osteo R/A Nail Systems and, when used with these nail systems, are subject to their specific indications.

# Indications for the T2 Locking Screws when used with Osteo IC Femoral and Tibial Nails (K992063):

- Open and closed femoral and tibial shaft fractures .
- Pseudoarthrosis and correction osteotomies .
- Pathologic fractures and tumor resections .
- Change of procedure following external fixation .

# Indications for the T2 Locking Screws when used with Osteo R/A Femoral Nails (K982601):

The Osteo R/A 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 implant .
- Nonunions and malunions ●

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use OR

vision Sign-Off Division of General, Restorative and Neurological Devices

510(k) Number 011622