The Osteonics® FX-Cablelok™ Grip Components are indicated for trochanteric reattachment and are intended for use with the commercially available Osteonics® FX-Cablelok™ System cable and sleeve components to provide fixation of the greater trochanter secondary to osteotomy in total hip replacement arthroplasty, surface replacement arthroplasty or any hip procedure requiring a trochanteric osteotomy.

Device Description

The subject devices are characterized by the following design features: Staple like grip design with proximal and distal hooks used in conjunction with trochanteric cable and crimp sleeves.

AI/ML Overview

The provided text is a 510(k) Premarket Notification for the Osteonics® FX-Cablelok™ Grip Components. This document establishes substantial equivalence to previously marketed devices and does not contain information about acceptance criteria, a standalone study proving performance, sample sizes for test/training sets, or specific details on ground truth establishment or expert involvement in a study.

Therefore, I cannot provide the requested information as the provided text does not describe a study that proves the device meets acceptance criteria. The document focuses on regulatory approval based on demonstrating equivalence to predicate devices, rather than presenting a performance study with acceptance criteria.

Summary

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5 1898 MAY

Osteonics® FX-Cablelok™ Grip Components

510(k) Premarket Notification

1980594

510(K) SUMMARY

OSTEONICS® FX-CABLELOK™ GRIP COMPONENTS

Submission Information Name and Address of the Sponsor:

Osteonics Corporation 59 Route 17 Allendale, NJ 07401-1677

Contact Person:

Donna S. Wilson Regulatory Affairs Specialist

February 16, 1998

Date of Summary Preparation:

Device Identification Proprietary Name:

Common Name:

Bone Fixation Accessory

Osteonics® FX-Cablelok™ Grip

CFR §888.3030

Components

Predicate Device Identification

Classification Name and Reference:

The subject devices are substantially equivalent to the following competitive and/or Osteonics devices, which have previously been determined substantially equivalent by FDA:

Howmedica Dall Miles Cable Grip System and Mini Cleat
FX-Cablelok™ System .

Device Description

The subject devices are characterized by the following design features: Staple like grip design with proximal and distal hooks used in conjunction with trochanteric cable and crimp sleeves.

Intended Use

The Osteonics® FX-Cablelok™ Grip Components are intended for use with the Osteonico® FX-Cablelok" System cable and sleeve components to provide fixation of the greater trochanter secondary to osteotomy in total hip replacement arthroplasty, surface replacement arthroplasty or any hip procedure requiring a trochanteric osteotomy.

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Osteonics® FX-Cablelok™ Grip Components

Indications

Trochanteric reattachment .

Statement of Technological Comparison:

The substantial equivalence of the subject device is supported by a comparison of the subject device to the above-cited predicate devices. A comparison of the subject and predicate devices in terms of intended use, materials, and design follows:

Intended Use - Trochanteric reattachment

Materials - Cobalt chromium alloy

Design - Staple like grip design used with cable and crimp sleeves.

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Image /page/2/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a caduceus, which is a symbol of medicine.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 5 1898

Ms. Donna S. Wilson Regulatory Affairs Specialist Osteonics Corporation 59 Route 17 07401-1677 Allendale, New Jersey

Re: K980594 Osteonics® FX-Cablelok™ Grip Components Trade Name: Requlatory Class: II Product Codes: LYT and JDQ February 16, 1998 Dated: Received: February 17, 1998

Dear Ms. Wilson:

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 Actronian include requirements for annual reqistration, 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. ದಿ 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 - Ms. Donna S. Wilson

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA asboinson in four 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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Cella 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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510(k) Number (if known): K

Device Name: Osteonics® FX-Cablelok™ Grip Components

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	✓	OR	Over-The-Counter Use
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(Per 21 CFR 801.109)

(Division Sign-Off)		(Optional Format 1-2-96)
Division of General Restorative Devices
510(k) Number	K980594

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.