MODIFIED LONG LENGTH GAMMA NAIL

K993670 · Howmedica Osteonics Corp. · HSB · Nov 16, 1999 · Orthopedic

Device Facts

• Record ID: K993670
• Device Name: MODIFIED LONG LENGTH GAMMA NAIL
• Applicant: Howmedica Osteonics Corp.
• Product Code: HSB · Orthopedic
• Decision Date: Nov 16, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of the modified Long Length Gamma® Nail is identical to that of the predicate Long Length Gamma® Nail: the product is intended to be used in fixation of femoral fractures occurring from the base of the femoral neck extending distally to a point approximately 10 cm proximal to the intracondylar notch. Fracture types include basilar neck, intertrochanteric, subtrochanteric fractures and femoral shaft fractures. These femoral fractures may occur as a result of trauma, non-union, mal-union, pathological fractures, and impending pathological fractures.

Device Story

Long Length Gamma® Nail is a cannulated intramedullary rod used for femoral fracture fixation. Device features medial/lateral and anterior/posterior curves. Modification involves changing the radius of curvature in the A-P plane to provide surgeons with increased intraoperative flexibility. Used by orthopedic surgeons in clinical settings for fracture management. Device provides structural stabilization of the femur, facilitating healing of fractures occurring from the base of the femoral neck to 10 cm proximal to the intercondylar notch.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Cannulated intramedullary rod; materials identical to predicate; features medial/lateral and anterior/posterior curves; modified radius of curvature in the A-P plane.

Indications for Use

Indicated for patients requiring fixation of femoral fractures, including basilar neck, intertrochanteric, subtrochanteric, and femoral shaft fractures resulting from trauma, non-union, mal-union, pathological conditions, or impending pathological fractures.

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

• Long Length Gamma® Nail (K993670)

Submission Summary (Full Text)

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## Nov | 6 1999

## Special 510(k) Summary - Device Modification Summary of Safety and Effectiveness for the Modified Long Length Gamma® Nail

| Proprietary Name: | Long Length Gamma® Nail |
|-------------------------------------|---------------------------------------------|
| Common Name : | Intramedullary Rod |
| Classification Name and Reference : | 21 CFR 888.3020 Intramedullary Fixation Rod |
| Proposed Regulatory Class : | Class II |
| Device Product Code : | 87 HSB |
| For Information contact: | Nancy Rieder |
| | Regulatory Affairs |
| | Howmedica Osteonics Corp. |
| | 359 Veterans Boulevard |
| | Rutherford, N.J. 07070 |
| | [phone] |
| | Fax: [phone] |

This Special 510(k) submission is intended to address a design modification to the predicate Long Length Gamma® Nail. The existing Long Length Gamma® Nail is an intramedually rod intended to be used in the fixation of femoral fractures 'occurring from the base of the femoral neck extending distally to a point approximately 10 cm proximal to the intercondylar notch. The current design is cannulated, with a medial/lateral and anterior/posterior curve. The design modification involves changing the radius of curvature in the A-P plane. The modified device will allow the surgeon greater intraoperative flexibility in treating a variety of femoral The modified Long Length Gamma® Nails are substantially equivalent to the fractures. existing design of Long Length Gamma® Nails, which were cleared for marketing via the The materials used in the manufacture of the modified device are identical to 510(k) process. those of the predicate. There is no change in intended use for the modified device when compared to the previously cleared product.

^' Historically, Howmedica Osteonics has intended this product to be used in fracture management as a result of trauma, non-unions, mal-unions, pathological fractures, and impending pathological fractures.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 6 1999

Ms. Margaret Crowe Howmedica Osteonics 359 Veterans Boulevard 07070-2584 Rutherford, New Jersey

K993670 Re: Long Length Gamma® Nail Trade Name: Regulatory Class: II Product Code: HSB October 29, 1999 Dated: Received: November 1, 1999

Dear Ms. Crowe:

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 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). 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 (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 Manufacturing 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 comply with the GMP requlation 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.

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## Page 2 - Ms. Margaret Crowe

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.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 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 requlation 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 Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

James F. Dillard III

James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K993670

Long length Gamma® Nail Device Name:

Indications For Use:

The intended use of the modified Long Length Gamma® Nail is identical to that of the predicate Long Length Gamma® Nail: the product is intended to be used in fixation of femoral fractures occurring from the base of the femoral neck extending distally to a point approximately 10 cm proximal to the intracondylar notch. Fracture types include basilar neck, intertrochanteric, subtrochanteric fractures and femoral shaft fractures. These femoral fractures may occur as a result of trauma, non-union, mal-union, pathological fractures, and impending pathological fractures.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)