MODIFICATION TO: LONG LENGTH GAMMA NAIL

K012158 · Howmedica Osteonics Corp. · HSB · Aug 1, 2001 · Orthopedic

Device Facts

• Record ID: K012158
• Device Name: MODIFICATION TO: LONG LENGTH GAMMA NAIL
• Applicant: Howmedica Osteonics Corp.
• Product Code: HSB · Orthopedic
• Decision Date: Aug 1, 2001
• 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 an intramedullary fixation rod used for femoral fracture management. Device is cannulated with medial/lateral and anterior/posterior curves. Modification involves changing the radius of curvature in the A-P plane to provide surgeons greater intraoperative flexibility. Device is implanted by surgeons in clinical settings to stabilize fractures from the femoral neck base to the distal femoral shaft. Benefit is improved anatomical fit and fracture fixation. Materials are identical to the predicate device.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Intramedullary fixation rod; cannulated design; medial/lateral and anterior/posterior curves; modified A-P plane radius of curvature. Materials are identical to the predicate device. Mechanical device; no software or energy source.

Indications for Use

Indicated for fixation of femoral fractures in patients with basilar neck, intertrochanteric, subtrochanteric, or femoral shaft fractures resulting from trauma, non-union, mal-union, pathological fractures, 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 (K012158)

Submission Summary (Full Text)

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## Special 510(k) Summary of Safety and Effectiveness:

## Device Modifications to the Long Length Gamma Nail

## 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: | July 10, 2001 |
| Device Identification | |

## Long Length Gamma® Nail Proprietary Name: Intramedullary Nail Common Name: Classification Name and Reference: Intramedullary Fixation Rod, 21 CFR §888.3020

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 intramedullary 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 fractures. The modified Long Length Gamma® Nails are substantially equivalent to the existing design of Long Length Gamma® Nail which was determined substantially equivalent via the 510(k) process. The materials used to manufacture the modified device are identical to those of the predicate. There is no change in intended use for the modified device when compared to the previously cleared product.

¹ 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is simple and recognizable, representing the department's role in public health and human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

1 2001 AUG

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

K012158 Re :

> Long Length Gamma® Nails Trade/Device Name: 888.3020 Regulation Number: Requlatory Class: II Product Code: HSB Dated: July 10, 2001 Received: July 11, 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 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). You may, therefore, market the device, subject to the general The general controls controls provisions of the Act. 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 be basyood of bacting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਰ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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 regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note:

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Page 2 - Ms. Ariemma

this response to your premarket notification submission does this response to your premained on the have under sections 531 not arrect any obligation for devices under the Electronic through 542 of the Act 101 xovisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as a This lecter will arrow your warket notification. The FDA described in your 510 (K) promazios of your device to a legally marketed predicate device results in a classification for your marketed predicate device robated in the market.

If you desire specific advice for your device on our labeling II you desire specific advice additionally 809.10 for in regulation (21 cm fare son and son and the Office of
vitro diagnostic devices), please contact the for guegti Compliance at [phone]. Additionally, for questions on Compliance at (301) 354 ining of your device, please contact the Dromocion and adversibling on July 2019 - Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other qeneral information on your responsibilities under the Act may be Information on your responsible of Small Manufacturers Assistance Obcalled from the Browbion [phone] or [phone] or at its internet address

"http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

втилелиноко

Celia M. Witten, Ph.D., M.D. Director Division of General Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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Page 1 of 1

510(k) Number (if known): K___________________________________________________________________________________________________________________________________________________

Device Name: Long Length Gamma® Nails

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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X

OR

(Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Asmuklellertpmcuu

(Division Sign-Off) (Division of General, Restorative and Neurological Devices

510(k) Number K012158