RESOLVE TONGS, SMALL/MEDIUM, RESOLVE TONGS, MEDIUM/LARGE, MODEL JT-200D, JT-100D

K071173 · Ossur Americans (Formerly the Jerome Group) · HAX · May 25, 2007 · Neurology

Device Facts

• Record ID: K071173
• Device Name: RESOLVE TONGS, SMALL/MEDIUM, RESOLVE TONGS, MEDIUM/LARGE, MODEL JT-200D, JT-100D
• Applicant: Ossur Americans (Formerly the Jerome Group)
• Product Code: HAX · Neurology
• Decision Date: May 25, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.5960
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ReSolve Tongs are intended for use to provide longitudinal traction to align vertebral structures, maintain reduction, or provide stabilization for a cervical spine injury.

Device Story

ReSolve Tongs are skull traction tongs used to provide longitudinal traction for cervical spine injuries; device aligns vertebral structures, maintains reduction, or provides stabilization. Device is an open tong design constructed from nonconductive E-glass (fiberglass). Used in clinical settings by healthcare professionals. Provides imaging compatibility with X-ray, CT, and MR. Nonconductive material offers safety advantage over conductive carbon composite predicates. Device functions via mechanical application of traction to the skull.

Clinical Evidence

Bench testing only. Device tested for mechanical integrity per ASTM F 1831-97, Section 10. Results confirmed compliance with standard requirements.

Technological Characteristics

Open tong design; material: E-glass (fiberglass); nonconductive; compatible with X-ray, CT, and MR imaging; sterilization: EtO; meets ASTM F 1831-97 for mechanical integrity of cranial traction tongs.

Indications for Use

Indicated for patients requiring longitudinal traction for cervical spine injury to align vertebral structures, maintain reduction, or provide 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

• JTongs Traction Tongs (K930021)

Reference Devices

• ReSolve Open Back Halo Ring (K051918)

Submission Summary (Full Text)

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MAY 2 5 2007

ÖSSUR

Life Without Limitations

April 24, 2007

## 510(k) Summarv As required by section 807.92(c)

## Trade Name: ReSolve Tongs Traction Tongs

Common Name: Traction Tongs

Classification Name: Tong, Skull for Traction, Sec. 882.5960, Neurological Devices, Class II, HAX

Substantially Equivalent To: JTongs Traction Tongs (K930021) manufactured by Jerome Medical . Also similar to the ReSolve Open Back Halo Ring (K051918) manufactured by Jerome Medical .

Description: The ReSolve Tongs are similar to other traction tongs which are used to provide longitudinal traction to align vertebral structures, maintain reduction, or provide stabilization for a cervical spine injury.

## Technological Characteristics Summary:

| | ReSolve Tongs | JTongs |
|-----------------------|--------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|
| Design | Open tong | Open tong |
| Materials | E-glass (fiberglass) | Carbon composite |
| Sterility | EtO Sterilized | EtO Sterilized |
| Electrical Safety | Nonconductive | Conductive |
| Imaging Compatibility | Compatible w/X-ray, CT,<br>MR | Compatible w/X-ray, CT |
| Performance | Meets requirements of<br>ASTM F 1831-97 for<br>Mechanical Integrity of<br>Cranial Traction Tongs | Meets requirements of<br>ASTM F 1831-97 for<br>Mechanical Integrity of<br>Cranial Traction Tongs |

The ReSolve Tongs are substantially equivalent to the predicate JTongs in all technological aspects except electrical safety. Laboratory tests confirm that the new nonconductive design meets the same standard for mechanical integrity as the previously approved JTongs.

Now Ossur Americas

internet www.ossur.com

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Non-clinical tests: The ReSolve Tongs were tested to the standard of ASTM F 1831-97, Section 10. They met the standard. The design change does not adversely affect product performance.

14071173

Intended Use: The ReSolve Tongs are intended for use to provide longitudinal traction to align vertebral structures, maintain reduction, or provide stabilization for a cervical spine injury.

Conclusions: The ReSolve Tongs are similar to the predicate device JTongs in function and indications for use. The devices are substantially equivalent

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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three faces in profile, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ossur Americas, Orthopaedics c/o Mr. Bernie Tatro Director of Distribution 1414 Metropolitan Avenue Paulsboro, New Jersey 08066

MAY 2 5 2007

Re: K071173

Trade/Device Name: ReSolve Tongs Traction Tongs Regulation Number: 21 CFR 882.5960 Regulation Name: Skull Tongs for Traction Regulatory Class: II Product Code: HAX Dated: April 26, 2007 Received: April 27, 2007

Dear Mr. Tatro:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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## Page 2 - Mr. Bernie Tatro

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. Millman

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): _

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

The ReSolve Tongs are intended for use to provide longitudinal traction to align vertebral structures, maintain reduction, or provide stabilization for a cervical spine injury.

Mark N. Millken

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

67-1173 510(k) Number

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)