The DePuy ACE Spider Plate is a low profile, "one-hole plate" design with a family of diameters to account for various fracture locations and spiked projections to engage the metaphyseal bone in any anatomic region. The DePuy ACE Spider Plate is also indicated for the fixation of soft tissue, such as tendon and ligaments, to bone in orthopaedic procedures. Five different overall diameters (three small, two large) have been designed to provide adequate clinical flexibility. The top profile has an overall diameter with a central hole for screw fixation; two of the washers have an offset screw hole with an additional k-wire hole. There are eight radiused cutouts producing eight arms that are designed to engage the metaphyseal bone.

AI/ML Overview

This document is a 510(k) summary for the DePuy ACE Spider Plate, seeking to expand its intended uses. It explicitly states that "The DePuy ACE Spider Plate has been previously cleared by the FDA for fracture fixation. Intended Uses are being expanded to include the fixation of soft tissue, such as tendon and ligaments, to bone."

The provided text does not contain information about specific acceptance criteria or a study proving the device meets them, especially not for the expanded indication. This document is a regulatory submission for substantial equivalence, not a clinical study report.

Therefore, the following information cannot be extracted from the provided text:

A table of acceptance criteria and the reported device performance
Sample size used for the test set and the data provenance
Number of experts used to establish the ground truth for the test set and their qualifications
Adjudication method for the test set
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size
If a standalone performance (algorithm only) was done
The type of ground truth used
The sample size for the training set
How the ground truth for the training set was established

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (Acumed Suture Washer) for the expanded indication of soft tissue fixation.

The key statements supporting this are:

"The DePuy ACE Spider Plate is also indicated for the fixation of soft tissue, such as tendon and ligaments, to bone in orthopaedic procedures."
"The Acumed Suture Washer (K965028) is intended for soft tissue fixation, small and large bone fixation and is used in conjunction with a titanium bone screw."
"The DePuy ACE Spider Plate and the Acumed Suture Washer are similar in design and function. Based on the above, DePuy ACE Medical Company considers the DePuy ACE Spider Plate to be substantially equivalent to the Acumed Suture Washer."

The FDA's response confirms substantial equivalence based on the submitted information for the expanded indications.

Summary

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3/23/99

Image /page/0/Picture/1 description: The image shows the logo for DePuy ACE. The logo consists of a black circle followed by the text "DePuy ACE" in a bold, sans-serif font. The letters are all capitalized, and the "ACE" portion of the logo is slightly smaller than the "DePuy" portion. There is a trademark symbol in the lower right corner of the logo.

K990392

510(k) SUMMARY

NAME OF FIRM:

510(k) CONTACT PERSON:

TRADE NAME:

COMMON NAME:

CLASSIFICATION:

2260 East El Segundo Boulevard El Segundo, CA 90245

DePuy ACE Medical Company

Kathleen Dragovich Regulatory Affairs Specialist DePuy ACE Medical Company 310 414-6257

DePuy ACE Spider Plate

Plate, Fixation, Bone

87HRS

888.3030 Single/Multiple component metallic bone fixation appliances and accessories

DEVICE CODE:

SUBSTANTIALLY EQUIVALENT DEVICES:

DePuy ACE Spider Plate Acumed Suture Washer DePuy ACE Orthopaedic Washer

INTENDED USE:

· Fixation of Metaphyseal Fractures of the Distal Tibia
· Proximal Metaphyseal Tibial Fractures
· Calcaneus Body Fractures
· Proximal Humeral Head/Shaft Fractures
· Distal Femur Fracture Comminuted Shaft Fractures
· Fixation of soft tissue, such as tendon and ligaments, to bone

DEVICE DESCRIPTION AND SUBSTANTIAL EQUIVALENCE RATIONALES:

The DePuy ACE Spider Plate has been previously cleared by the FDA for fracture fixation. Intended Uses are being expanded to include the fixation of soft tissue, such as tendon and ligaments, to bone.

The Acumed Suture Washer (K965028) is intended for soft tissue fixation, small and large bone fixation and is used in conjunction with a titanium bone screw. The DePuy ACE Spider Plate and the Acumed Suture Washer are similar in design and function. Based on the above, DePuy ACE Medical Company considers the DePuy ACE Spider Plate to be substantially equivalent to the Acumed Suture Washer.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle's head in profile, with three parallel lines extending upwards to represent wings or feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 3 1999

Mr. Paul Doner Director, Regulatory and Clinical Affairs DePuy ACE Medical Company 2260 East El Segundo Boulevard El Segundo, California 90245-4694

Re: K990392 DePuy ACE Spider Plate Trade Name: Requlatory Class: II Product Code: HRS February 1, 1999 Dated: February 9, 1999 Received:

Dear Mr. Doner:

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 able beath in 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 The general controls provisions of the Act 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 Requlations, Title 21, Parts 800 to 895. ದ 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 Failure to Administration (FDA) will verify such assumptions. comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements Please note: concerning your device in the Federal Register. 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. Paul Doner

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 (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.qov/cdrh/dsmamain.html".

Sincerely yours,

G. Colia M. Witten, Ph.D., M

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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Image /page/3/Picture/0 description: The image shows the logo for DePuy ACE. The logo consists of a black circle followed by the text "DePuy ACE" in a bold, sans-serif font. The letters are all capitalized, and there is a small trademark symbol in the bottom right corner of the "E".

510(k) Number (if known) _ K990392

Device Name: DePuy ACE Spider Plate

Indication for User:

· Fixation of Metaphyseal Fractures of the Distal Tibia
· Proximal Metaphyseal Tibial Fractures
· Calcaneus Body Fractures
· Proximal Humeral Head/Shaft Fractures
Distal Femur Fracture Comminuted Shaft Fractures
· Fixation of soft tissue, such as tendon and ligaments, to bone

Concurrence of CDRH, Office of Device Evaluation (Division Dign-Off) Division of General Restorative Devices 510(k) Number _

Prescription Use X (Per 21 CFR 801.109)

Over-The-Counter ___________

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.