FRIDDLE HALO SYSTEM, FRIDDLE MRI HALO SYSTEM

K980689 · Friddle'S Orthopedic Appliances, Inc. · HAX · Feb 18, 1999 · Neurology

Device Facts

• Record ID: K980689
• Device Name: FRIDDLE HALO SYSTEM, FRIDDLE MRI HALO SYSTEM
• Applicant: Friddle'S Orthopedic Appliances, Inc.
• Product Code: HAX · Neurology
• Decision Date: Feb 18, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5960
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

This device is designed to provide traction and/or to immobilize a patient with a cervical spine injury or after surgery.

Device Story

Friddle Halo System is a cranial immobilization device designed to hold the skull firmly relative to the torso to immobilize cervical vertebrae. The system consists of a ring, rods, and braces made of carbon fiber-epoxy composite, worn over a high-density polyethylene vest lined with Kodel or sheepskin. Cranial fixation is achieved via CP titanium skull pins. The device is used in clinical settings to manage patients following cervical spine surgery or injury. It functions as a mechanical stabilization system; it does not involve electronic inputs, software, or automated processing. The device provides external skeletal fixation to maintain spinal alignment, aiding in patient recovery and preventing further injury.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Materials: CP titanium (skull pins), carbon fiber-epoxy composite (rods/braces), high-density polyethylene (vest), Kodel/sheepskin (lining). Mechanical immobilization system; no energy source, software, or connectivity. Sterilization method not specified.

Indications for Use

Indicated for patients requiring cervical spine traction or immobilization due to injury (fracture or dislocation) or post-surgical stabilization.

Regulatory Classification

Identification

Skull tongs for traction is an instrument used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation). The device is caliper shaped with tips that penetrate the skin. It is anchored to the skull and has a heavy weight attached to it that maintains, by traction, the patient's position.

Predicate Devices

• Halo Traction Cervical Immobilizer (K822885)
• Bremer Imaging Tongs, MRI model (K924506)
• Ace Cervical Traction Halozs, Tongs, and Pins (K954069)
• Halo Ring (K930153)
• PMT Halo/Orthopedic Jacket System (K834047)

Submission Summary (Full Text)

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2/18/99

XII. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (Separate Page)

K980689

- A. Submitter; Frank Friddle, Jr., Friddle's Orthopedic Appliances, Inc., 12306 Belton Honea Path Hwy, Honea Path, SC, 29654
- I. Classification: Class II.
- II. Common or usual name: Halo traction or immobilization system,

III. Proprietary Name: Friddle's Halo System™

IV. Registration No .: 1053709

V. Classification Name: Cranial Skull Tongs, 84HAX, CFR 882.5960, Class II.

VI. Performance standards: None. Titanium alloy meets ASTM specifications.

VII. Description:

The Friddle Halo system is very similar to several halo systems, which are designed to hold the skull firmly in place relative to the torso so that the cervical vertabrae are immobolized after surgery or injury. The system is comprised of a ring, rods, and braces system made of a carbon fiber-epoxy composite which is placed over a vest made of high-density polyethylene, lined with Kodel or sometimes sheepskin. The skull pins are made of CP titanium. The titanium skull pins, carbon fiber-epoxy composite rods, high-density polyethylene, Kodel, and sheepskin are used throughout the industry.

VIII. Labels and Labeling: Labels and Instructions for Use are provided. Competitive labels and labeling are provided.

IX. Indications for Use: To provide traction/immobilize a patient with a cervical spine injury (fracture or dislocation)

- X. Substantial Equivalence:
The Friddle Halo System is substantially equivalent to the classified device and to other devices cleared for marketing by the 510(k) process such as the "Halo Traction Cervical Immobilizer" (K822885), "Bremer Imaging Tongs, MRI model" (K924506), "Ace Cervical Traction Halozs, Tongs, and Pins," (K954069), the "Halo Ring" (K930153), and is most similar to the PMT Halo/Orthopedic Jacket System (K834047). Several of these products are listed below for convenient reference. The "510(k) Substantial Equivalence Decision-making Process (Detailed) from ODE Guidance Memorandum #86-3 was followed.

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Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized image of an eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 8 1999

Mr. Frank E. Friddle, Jr. President Friddle's Orthopedic Appliances 12306 Belton-Honea Path Highway P.O. Box 207 Honea Path, South Carolina 29654

Re: K980689 Trade Name: Friddle Halo System™ Regulatory Class: II Product Code: HAX Dated: January 20, 1999 Received: January 21, 1999

Dear Mr. Friddle:

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 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. Frank E. Friddle, Jr.

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" (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,

Celia M. Witten, Ph.D., M.D.
Director

Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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IX. Indications for Use: [Separate Page]

## 510(k) Number: # K980689

Device Name: Friddle Halo System™.

Indications for Use: This device is designed to provide traction and/or to immobilize a patient with a cervical spine injury or after surgery.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|-----------------------------------------|---------|
| Division of General Restorative Devices | K980689 |
| 510(k) Number | |

| Prescription Use | <div> <img alt="Checkmark" src=""/> </div> |
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| (Per 21 CFR 801.109) | |

Over The Counter Use
(Optional Format 1-2-96)(repl. p. 4)

(Optional Pormal 1-2-90,