GAMMA3 NAIL SYSTEM

K043431 · Howmedica Osteonics Corp. · HSB · Feb 16, 2005 · Orthopedic

Device Facts

• Record ID: K043431
• Device Name: GAMMA3 NAIL SYSTEM
• Applicant: Howmedica Osteonics Corp.
• Product Code: HSB · Orthopedic
• Decision Date: Feb 16, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of the Gamma3 Nail System includes the following: Trochanteric Gamma3 Nail The Trochanteric Gamma3 Nail is intended for use in stabilizing various types of stable and unstable intertrochanteric fractures including peritrochanteric fractures. Long Length Gamma3 Nail The Long Length Gamma3 Nail is intended for fixation of stable and unstable femoral fractures occurring from the base of the femoral neck extending distally to a point approximately 10 cm proximal to the intercondylar notch including fractures of the basilar neck, intertrochanteric fractures, peritrochanteric fractures, subtrochanteric fractures and femoral shaft fractures.

Device Story

Gamma3 Nail System is a family of intramedullary nails, lag screws, and locking screws for femoral fracture fixation. Subject device is a line extension adding components to previously cleared system. Used by orthopedic surgeons in clinical/surgical settings to stabilize fractures; device provides mechanical fixation of bone fragments. Benefits include stabilization of fractures in patients with osteoporotic bone or metastatic disease via U-Blade Lag Screw. No software or AI components.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Intramedullary fixation rod system consisting of nails, lag screws, locking screws, and set screws. Metallic construction consistent with predicate devices. Mechanical fixation principle. No software, electronics, or energy sources.

Indications for Use

Indicated for fixation of stable and unstable intertrochanteric fractures (including nonunion, malunion, tumor resections) and femoral fractures (trauma, nonunion, malunion, pathological/impending pathological fractures, tumor resections, revision). U-Blade Lag Screw indicated for patients with highly osteoporotic bone, metastatic disease in femoral head, short femoral head/neck fragments, or unstable intertrochanteric fractures with missing medial-caudal bone support.

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

• Gamma3 Nail System (K034002)
• Gamma3 Nail System (K032244)

Submission Summary (Full Text)

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FEB 1 6 2005

K 043431
Traditional 510(k) Premarket Notification

# 510(k) Summary of Safety and Effectiveness: Line Extension to the Gamma3 Nail System

#### Submission Information

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

Contact:

Howmedica Osteonics Corp 325 Corporate Drive Mahwah, NJ 07430

Jennifer Kosoy, Regulatory Affairs Specialist Howmedica Osteonics Corp. 325 Corporate Drive Mahwah. NJ 07430 Phone: [phone] Fax: [phone] Email: [e-mail]

### Date Summary Prepared

December 9, 2004

#### Device Identification

Proprietary Name: Common Name: Classification Name and Reference:

Device Product Code: Predicate Device:

Gamma3® Nail System Intramedullary Nail Intramedullary Fixation Rod and Accessories, 21 CFR 8888.3020 87 HSB Gamma3 Nail System, K034002 and K032244

#### Description

The Gamma3® Nail System is a family of intramedullary nails for basilar neck, intertrochanteric, subtrochanteric and femoral shaft fractures and consists of nails, lag screws, locking screws and set screws. The subject device is a line extension to the Gamma3 Nail System previously cleared in 510(k)s K034002 and K032244 to provide additional components and accessories to the system.

#### Intended Use

The intended use of the Gamma3 Nail System includes the following:

#### Trochanteric Gamma30 Nail

The Trochanteric Gamma3® Nail is intended for use in stabilizing various types of stable and unstable intertrochanteric fractures including peritrochanteric fractures.

## Long Length Gamma30 Nail

The Long Length Gamma3 Nail is intended for fixation of stable and unstable femoral fractures occurring from the base of the femoral neck extending distally to a point approximately 10 cm proximal to the intercondylar notch including fractures of the basilar neck, intertrochanteric fractures, peritrochanteric fractures, subtrochanteric fractures and femoral shaft fractures.

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# Indications for Use

The Trochanteric Gamma3® Nail is indicated for fixation of stable and unstable intertrochanteric fractures, including but not limited to nonunion, malunion and tumor resections, while the Long Length Gamma3® Nail indications may include fractures resulting from trauma, nonunion, malunion, pathological fractures, impending pathological fractures, tumor resections and revision procedures.

The Gamma3® U-Blade Lag Screw may be used with either the Gamma3® Trochanteric Nail or the Long Length Gamma3 Nail to treat patients with highly osteoporotic bone or metastatic disease in the femoral head, short femoral head/neck fragments, or unstable intertrochanteric fractures with missing medial-caudal bone support.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 6 2005

Ms. Jennifer Kosoy Regulatory Affairs Specialist Howmedica Osteonics Corp 325 Corporate Drive Mahwah, New Jersey 07430

Re: K043431

Ro45451
Trade/Device Name: Line Extension to the Gamma® 3 Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Codes: HSB Dated: December 10, 2004 Received: December 13, 2004

Dear Ms. Kosoy:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon 910(t) premained is substantially equivalent (for the indications felerenced above and nave determined the articled predicate devices marketed in interstate for use stated in the enorosale) to regard) the enactment date of the Medical Device American Council Food. Drus commerce prior to May 28, 1776, the enated with the provisions of the Federal Food. Drug, devices mat have been recultsmed in assee approval of a premarket approval application (PMA). and Cosment Act (Act) that do not require appro the general controls provisions of the Act. The 1 ou may, merciole, market the act include requirements for annual registration, listing of gencial controls provisions of the rest 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 ( If your device is classified (500 a0070) als. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulation Fif may be subject to such additional controllations, Title 21, Parts 800 to 898. In addition, FDA may be found in the Ood of Peace concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DA 3 issualled of a badenian.
that FDA has made a determination that your device complies with other requirements of the Act that I DA has made a determination an Journistered by other Federal agencies. You must of any rederal statutes and regulations animations but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as setsen CFK Fart 807), adocing (21 OFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Jennifer Kosoy

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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.

Sincerely yours,

Mark A. Millerson

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):

Device Name: Line Extension to the Gamma®3 Nail System

and the comments of the comments of the comments of the comments of the comments of

#### Indications For Use:

The Trochanteric Gamma3® Nail is indicated for fixation of stable and unstable intertrochanteric fractures, including but not limited to nonunion, malunion and tumor resections, while the Long Length Gamma3® Nail indications may include fractures resulting from trauma, nonunion, malunion, pathological fractures, impending pathological fractures, turnor resections and revision procedures.

The Gamma3® U-Blade Lag Screw may be used with either the Gamma3® Trochanteric Nail or the Long Length Gamma3® Nail to treat patients with highly osteoporotic bone or metastatic disease in the femoral head, short femoral head/neck fragments, or unstable intertrochanteric fractures with missing medial-caudal bone support.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use **X**
AND/OR
Over-The-Counter Use **__**
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)

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

K043431

510(k) Number_