DEPUY ACE SPIDER PLATE by DEPUY ACE MEDICAL CO.

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. 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

The provided text describes a 510(k) submission for a medical device called the "DePuy ACE Spider Plate." This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving the device meets specific performance criteria through a study with acceptance criteria.

Therefore, the input does not contain information about:

A table of acceptance criteria and reported device performance.
Sample size used for a test set or data provenance.
Number of experts used to establish ground truth or their qualifications.
Adjudication method for a test set.
Multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
Standalone (algorithm only) performance.
Type of ground truth used (expert consensus, pathology, outcomes data).
Sample size for a training set.
How ground truth for the training set was established.

The document focuses on establishing substantial equivalence to a predicate device (Acumed Suture Washer) based on similar design and function, rather than presenting a performance study against predefined acceptance criteria.

Summary

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DEC 31 1998

K984458

Image /page/0/Picture/2 description: The image shows the logo for DePuy ACE. The logo consists of a black circle on the left, followed by the text "DePuy ACE" in black, bold letters. The letters are sans-serif and the word "ACE" is slightly smaller than "DePuy". There is a trademark symbol to the right of the letter E.

510(k) SUMMARY

NAME OF FIRM:

510(k) CONTACT PERSON:

DePuy ACE Medical Company 2260 East El Segundo Boulevard El Segundo. CA 90245

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

TRADE NAME:

COMMON NAME:

CLASSIFICATION:

DEVICE CODE:

SUBSTANTIALLY EQUIVALENT DEVICE:

DePuy ACE Spider Plate

Plate, Fixation, Bone

888.3030 Single/Multiple component metallic bone fixation appliances and accessories

87HRS

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

DEVICE DESCRIPTION AND SUBSTANTIAL EQUIVALENCE RATIONALES:

The Acumed Suture Washer (K965028) is intended for 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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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the bird figure in a circular fashion.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 3 1 1998

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

K984458 Re: Spider Plate Regulatory Class: II Product Codes: HRS and HTN Dated: December 11, 1998 Received: December 15, 1998

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 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). 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 requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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 - 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" (21CFR 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/dsma/dsmamain.html".

Sincerely yours.

Russell J. Pagano

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 the "TM" symbol is located in the bottom right corner of the "E" in "ACE". The logo is simple and professional, and the black color gives it a strong and authoritative look.

K984458

510(k) Number (if known)

DePuy ACE Spider Plate Device Name:

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

Concurrence of CDRH, Office of Device Evaluation

Prescription Use
(Per 21 CFR 801.109) X

Over-The-Counter

Russell V. Payano for cmw

(Division Sign-Off) Division of General Re: 510(k) Number

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.