MAGELLAN HUMERAL INTRAMEDULLARY NAIL

K992856 · Orthomatrix, Inc. · HSB · Mar 10, 2000 · Orthopedic

Device Facts

• Record ID: K992856
• Device Name: MAGELLAN HUMERAL INTRAMEDULLARY NAIL
• Applicant: Orthomatrix, Inc.
• Product Code: HSB · Orthopedic
• Decision Date: Mar 10, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MAGELLAN™ Intramedullary Humeral Nail System is indicated for use in long bone shaft fractures of the humerus which require stabilization of the axis of the bone. These include shaft fractures, segmented fractures, fractures with bone loss, comminuted fractures, proximal and distal fractures, non-unions and malunions.

Device Story

The Magellan Humeral Intramedullary Nail System is an orthopedic implant designed for the stabilization of humeral shaft fractures. The device is surgically implanted by an orthopedic surgeon in an operating room setting. It functions as an internal fixation device to maintain bone alignment and support healing in cases of fractures, non-unions, or malunions. By providing mechanical stability to the humeral axis, the nail facilitates bone union and restores structural integrity to the humerus. The healthcare provider uses the device to stabilize the fracture site, which aids in patient recovery and functional restoration of the limb.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Intramedullary nail system for humeral fixation. Mechanical device; no software, electronics, or energy source. Materials and specifications not detailed in provided text.

Indications for Use

Indicated for patients with humeral long bone shaft fractures requiring stabilization, including shaft, segmented, comminuted, proximal, distal fractures, bone loss, non-unions, 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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 0 2000

Mr. Ben Shappley President OrthoMatrix, Inc. 711 Chaney Cove Collierville, Tennessee 38017

Re: K992856

Trade Name: Magellan Humeral Intramedullary Nail Regulatory Class: II Product Code: HSB Dated: January 12, 2000 Received: January 13, 2000

Dear Mr. Shappley:

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 control 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 requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with 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.

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Page 2 - Mr. Ben Shappley

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 regulation (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 regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/dsma/dsmamain.html".

Sincerely yours.

Henry C. Taylor

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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## INDICATIONS FOR USE OF THE DEVICE

Device Name: MAGELLAN Intramedullary Humeral Nail System

Indications for Use:

The MAGELLAN™ Intramedullary Humeral Nail System is indicated for use in long bone shaft fractures of the humerus which require stabilization of the axis of the bone. These include shaft fractures, segmented fractures, fractures with bone loss, comminuted fractures, proximal and distal fractures, non-unions and malunions.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Div
Div of General Restorative Devices
510(k) Number 16992856

Prescription Use
(per 21 CFR 801.109)
+
OR

Over-the-Counter Use