CABLE SCREW WITH INTEGRAL CRIMP

• K Number: K980690
• Device Name: CABLE SCREW WITH INTEGRAL CRIMP
• Manufacturer: PIONEER SURGICAL TECHNOLOGY
• Date Cleared: 1998-05-22 ( 88 days)
• Product Code: JDQ
• Regulation Number: 888.3010
• Type: Traditional
• Panel: Orthopedic
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

The Cable Screw with Integral Crimp is indicated where a fracture may not be securely held by either a screw or a cerclage cable alone. The device can be used in conjunction with plating:

• humeral fractures
• medial malleolus fractures
• butterfly fractures requiring interfragmentary fixation with cerclage cabling
• femur fractures
• pelvic fractures
• forearm shaft fractures
• patellar fractures
• olecranon fractures
• proximal tibial and tibial shaft fractures

Device Description

Pioneer Laboratories Cable Screw with Integral Crimp

AI/ML Overview

I'm sorry, I cannot fulfill this request. The provided text is a 510(k) summary and approval letter for a bone fixation device, specifically a "Cable Screw with Integral Crimp." This document describes the administrative information, device identification, classification, and FDA approval of the device.

However, the provided text does not contain any information regarding acceptance criteria, study details, device performance data, sample sizes, expert qualifications, adjudication methods, or multi-reader multi-case studies.

Therefore, I cannot extract the requested information to populate the table or answer the specific questions about device performance and study methodology. The document is solely focused on the regulatory approval process and not on the technical performance testing details.

Summary

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510(K) Summary

K980690 Pioneer Laboratories 510(K) Notification Summary For Cable Screw with Integral Crimp

Administrative Information

Manufacturer Identification and Sponsor:

Pioneer Laboratories 375 River Park Circle Marquette, MI 49855-1781 Telephone: [phone] FAX: [phone]

Official Contact:

Burns Severson Vice President, Regulatory Affairs/Quality Assurance

Date Prepared: 7/22/97

Device Identification

Proprietary:

Pioneer Laboratories Cable Screw with Integral Crimp

Common Names:

Screw, Fixation, Bone Cerclage Cable

Classification Name and Reference:

In the code of Federal Regulations, Volume 21, FDA identified bone screws, fixation as Class II devices.

Regulation Number:	888.3040
Classification Number:	87HWC

Cerclage, Bone Fixation
Regulation Number:	888.3010
Classification Number:	87JDQ
Class II

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Image /page/1/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUM. SERVICES - USA" arranged around the top half of the circle. In the center of the seal is a stylized image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 2 1998

Mr. Burns Severson Senior Vice President Pioneer Laboratories, Inc. 375 River Park Circle Marquette, Michigan 49855

Re: K980690 Cable Screw with Integral Crimp Regulatory Class: II Product Code: JDQ and JWC Dated: February 20, 1998 February 23, 1998 Received:

Dear Mr. Severson:

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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਸ 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 requlations.

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Page 2 - Mr. Burns Severson

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

Enclosure

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Pioneer Laboratories

Cable Screw with Integral Crimp

Indications for Use

The Cable Screw with Integral Crimp is indicated where a fracture may not be securely held by either a screw or a cerclage cable alone. The device can be used in conjunction with plating:

• humeral fractures
• medial malleolus fractures
• butterfly fractures requiring interfragmentary fixation with cerclage cabling
• femur fractures
• pelvic fractures
• forearm shaft fractures
• patellar fractures
• olecranon fractures
• proximal tibial and tibial shaft fractures

Acoosta

(Division Sign-Off)
Division of General Restorative Devices,
510(k) Number. K980690

Prescription Use (Per 21 CFR 801.109)

Regulation Number and Section

§ 888.3010 Bone fixation cerclage.

(a)
Identification. A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.(b)
Classification. Class II.