DEPUY ACE AIM(R) TITANIUM SUPRACONDYLAR NAIL

K974781 · Depuy, Inc. · HSB · Mar 10, 1998 · Orthopedic

Device Facts

• Record ID: K974781
• Device Name: DEPUY ACE AIM(R) TITANIUM SUPRACONDYLAR NAIL
• Applicant: Depuy, Inc.
• Product Code: HSB · Orthopedic
• Decision Date: Mar 10, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

AIM® Titanium Supracondylar Nail is a straight, cannulated intramedullary fixation rod used for femoral supracondylar fractures and tibiotalocalcaneal fusions. Device features proximal and distal locking holes for screw fixation and a threaded endcap to prevent bony ingrowth. Used by orthopedic surgeons in clinical/surgical settings to stabilize bone fractures or facilitate arthrodesis. Provides mechanical fixation to support bone healing and restore structural integrity in patients with trauma, arthrosis, or failed previous procedures.

Clinical Evidence

Bench testing only; mechanical stiffness compared to crossed lag screws.

Technological Characteristics

Straight, cannulated intramedullary nail; diameters 10mm and 12mm; lengths 15, 20, 25, 30cm. Material: Ti-6Al-4V alloy. Includes proximal/distal locking screws and endcap.

Indications for Use

Indicated for patients requiring intramedullary fixation for supracondylar femoral fractures (including comminuted, intraarticular, osteoporotic, pathologic, nonunion/malunion, or periprosthetic fractures) and patients requiring tibiotalocalcaneal fusion or treatment for hindfoot/distal tibia trauma (including failed ankle arthrodesis, absent talus, post-traumatic/primary arthrosis, rheumatoid hindfoot, avascular necrosis, or failed total arthroplasty).

Regulatory Classification

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.

Predicate Devices

• ACE Medical AIM® Titanium Supracondylar Nail (K974781)
• Smith & Nephew Orthopaedics Richards Supracondylar Nail System

Submission Summary (Full Text)

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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:

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 DESCRIPTIONS AND SUBSTANTIAL EQUIVALENCE RATIONALES:

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.

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

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 [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,

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)

OR

Over-The-Counter

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Division of General Restorative Devices
510(k) Number K974781