DEPUY ACE AIM(R) TITANIUM SUPRACONDYLAR NAIL by DEPUY, INC.

The AIM® Titanium Supracondylar Nail is intended for use in intramedullary fixation of supracondylar fractures of the femur, including those with severe comminution and intraarticular involvement, osteoporosis, nonunions, malunions, pathologic, and fractures proximal to total knee arthroplasty or prosthesis. In addition, the AIM® Titanium Supracondylar Nail is indicated for use in tibiotalocalcaneal fusions and treatment of trauma to the hindfoot and distal tibia. Indications include: Revision after failed ankle arthrodesis with subtalar involvement; Absent talus (Tibio Calcaneal Arthrodesis); Post traumatic/primary arthrosis involving both ankle and subtalar joints; A rheumatoid hindfoot; Avascular necrosis of the talus; Previously infected arthrosis, second degree; Failed total arthroplasty.

Device Description

The AIM® Titanium Supracondylar Nail is a straight, cannulated intramedullary nail available in diameters of 10 and 12mm and lengths of 15, 20, 25, and 30cm. Holes in the nail allow for proximal and distal locking. The distal locking screws have a diameter of 6.5mm. The proximal locking screws have a diameter of 4.5mm. An endcap is also provided. The endcap threads into the distal end of the nail to prevent bony ingrowth and facilitate attachment of removal instrumentation. The AIM® Titanium Supracondylar Nail, proximal and distal locking screws, and endcap are all manufactured from Ti-6A1-4V alloy.

AI/ML Overview

Based on the provided text, the acceptance criteria and the study that proves the device meets the acceptance criteria are described as follows:

1. Acceptance Criteria and Reported Device Performance:

The document focuses on demonstrating substantial equivalence based on mechanical properties. The acceptance criterion is that the device should be "as stiff or stiffer" compared to a common method of fixation.

Acceptance Criterion	Reported Device Performance
As stiff or stiffer than crossed lag screws	Tested as stiff or stiffer in comparison to the common method of fixation, crossed lag screws.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify the sample size used for the mechanical "test set." It is a mechanical performance study, not a clinical trial with patient data, so "data provenance" in terms of country of origin or retrospective/prospective is not applicable in the way it would be for AI/clinical studies.

3. Number of Experts and Qualifications:

Not applicable. This was a mechanical engineering test, not a study requiring expert clinical assessment for ground truth.

4. Adjudication Method for the Test Set:

Not applicable. This was a mechanical engineering test.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. This is a 510(k) submission for a medical implant (intramedullary nail) and involves a mechanical performance study, not an AI device. Therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance is not relevant.

6. Standalone Algorithm Performance:

No. This submission is for a physical medical device, not an algorithm or AI.

7. Type of Ground Truth Used:

The "ground truth" in this context is the mechanical stiffness of the comparative fixation method (crossed lag screws). This would be established through established biomechanical testing protocols and engineering principles.

8. Sample Size for the Training Set:

Not applicable. This is a mechanical performance test of a physical device, not an AI model that requires a "training set."

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set for a mechanical device. The "ground truth" for the performance comparison (stiffness of crossed lag screws) would be established through biomechanical testing of those screws according to accepted engineering standards.

Summary

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MAR 1 0 1998

NAME OF FIRM:

510(K) CONTACT:

TRADE NAME:

COMMON NAME:

CLASSIFICATION:

510(k) SUMMARY

DePuv ACE Medical Company 2260 Fast El Segundo Boulevard El Segundo, CA 90245

Kathleen Dragovich Regulatory Affairs Specialist

DePuy ACE AIM® Titanium Supracondylar Nail

Intramedullary Fixation Rod

888.3020 Rod. Fixation, Intramedullary and Accessories

DEVICE PRODUCT CODE:

87 HSB

SUBSTANTIALLY EQUIVALENT DEVICES:

ACE Medical AIM® Titanium Supracondylar Nail
Smith & Nephew Orthopaedics Richards Supracondylar Nail System

INTENDED USE:

DEVICE DESCRIPTIONS AND SUBSTANTIAL EQUIVALENCE RATIONALES:

The AIM® Titanium Supracondylar Nail has been previously cleared by FDA, intended for intramedullary fixation of supracondylar fractures of the femur. As the DePuy ACE A.I.M. Titanium Supracondylar Nail has tested as stiff or stiffer in comparison to the common method of fixation, crossed lag screws, it is considered to be acceptable for tibiotalocalcaneal arthrodesis.

K974781

K97478

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is facing to the right. The logo is simple and clean, and it is easily recognizable.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 0 1998

Ms. Kathleen A. Dragovich Regulatory Affairs Specialist DePuy ACE Medical Company 2260 East El Sequndo Boulevard El Segundo, California 90245-4694

Re: K974781 DePuy ACE AIM® Titanium Supracondylar Nail Regulatory Class: II Product Code: HSB Dated: December 19, 1997 Received: December 22, 1997

Dear Ms. Dragovich:

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 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 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 requlatory 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. Kathleen A. Dragovich

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.gov/cdrh/dsmamain.html".

Sincerely yours,

a 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)

K974781

DePuy ACE AIM® Titanium Supracondylar Nail Device Name:

Indication For User:

The AIM® Titanium Supracondylar Nail is intended for use in intramedullary fixation of supracondylar fractures of the femur, including those with severe comminution and intraarticular involvement, osteoporosis, nonunions, pathologic, and fractures proximal to total knee arthroplasty or prosthesis. In addition, the AIM® Titanium Supracondylar Nail is indicated for use in tibiotalocalcaneal fusions and treatment of trauma to the hindfoot and distal tibia. Indications include: Revision after failed ankle arthrodesis with subtalar involvement; Absent talus (Tibio Calcaneal Arthrodesis); Post traumatic/primary arthrosis involving both ankle and subtalar joints; A rheumatoid hindfoot; Avascular necrosis of the talus; Previously infected arthrosis, second degree; Failed total arthroplasty.

Concurrence of CDRH, Office of Device Evaluation

Prescription Use
X
(Per 21 CFR 801.109)

Over-The-Counter

_
(Division Sign-Off)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K974781

Regulation Number and Section

§ 888.3020 Intramedullary fixation rod.

(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.