DEPUY ACE A.I.M. TITANIUM TIBIAL NAIL

K972183 · Ace Medical Co. · HSB · Aug 26, 1997 · Orthopedic

Device Facts

• Record ID: K972183
• Device Name: DEPUY ACE A.I.M. TITANIUM TIBIAL NAIL
• Applicant: Ace Medical Co.
• Product Code: HSB · Orthopedic
• Decision Date: Aug 26, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The DePuy ACE A.I.M.º Titanium Tibial Nail is indicated for internal fixation of tibial fractures including transverse fractures, oblique fractures, spiral fractures, comminuted fractures, fractures, fractures with bone loss, bone transport, open fractive osteotomies, pathologic fractures, pseudoarthrosis of the tibial shaft, nonunions, malunions, metaphyseal fractures and epiphyseal fractures.

Device Story

Intramedullary fixation device for tibial fractures; titanium nail inserted into tibial canal to stabilize bone segments. Features distal bend (2° or 5° depending on diameter) and proximal dynamization slot; includes multiple cross-locking screw holes for cortical bone screws. Used by orthopedic surgeons in clinical/OR settings. Provides mechanical stability to fracture site; allows for compression or dynamization to promote healing. Benefits patient by facilitating bone alignment and stabilization during fracture recovery.

Clinical Evidence

Bench testing only. Biomechanical testing compared subject device to Synthes Tibial Nail; results indicated subject device was at least as strong or stronger than the comparator.

Technological Characteristics

Titanium 6Al-4V ELI (ASTM F-136). Diameters 8.0mm-13.0mm; lengths from 25.5cm. 8mm/9mm nails are solid; 10mm-13mm nails are cannulated. Distal bend 2° (10-12mm) or 5° (8-9mm). Proximal dynamization slot (5mm). Mechanical fixation via cross-locking screws.

Indications for Use

Indicated for internal fixation of tibial fractures in patients requiring stabilization of transverse, oblique, spiral, comminuted, segmental, or pathologic fractures; also indicated for bone transport, corrective osteotomies, pseudoarthrosis, nonunions, malunions, metaphyseal, and epiphyseal fractures.

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

• DePuy ACE AIM® Titanium Tibial Nail (K972183)
• Synthes Reamed Titanium Tibial Nail
• Synthes Unreamed Titanium Tibial Nail

Submission Summary (Full Text)

{0}------------------------------------------------

AUG 26 1997

K972183

510(k) SUMMARY

| NAME OF FIRM: | DePuy ACE Medical Company<br>2260 East El Segundo Boulevard<br>El Segundo, CA 90245 |
|-------------------------------------|-------------------------------------------------------------------------------------|
| 510(k) CONTACT PERSON: | Kathleen A. Dragovich<br>Regulatory Affairs Specialist<br>DePuy ACE Medical Company |
| TRADE NAME: | DePuy ACE A.I.M.® Titanium Tibial Nail |
| COMMON NAME: | Intramedullary Rod |
| CLASSIFICATION: | 888.3020 Rod, Fixation, Intramedullary and<br>Accessories |
| DEVICE CODE: | 87HSB |
| SUBSTANTIALLY<br>EQUIVALENT DEVICE: | DePuy ACE AIM® Titanium Tibial Nail |

## INTENDED USE:

The DePuy ACE A.I.M.º Titanium Tibial Nail is indicated for internal fixation of tibial fractures including transverse fractures, oblique fractures, spiral fractures, comminuted fractures, fractures, fractures with bone loss, bone transport, open fractive osteotomies, pathologic fractures, pseudoarthrosis of the tibial shaft, nonunions, malunions, metaphyseal fractures and epiphyseal fractures.

## DEVICE DESCRIPTION AND SUBSTANTIAL EQUIVALENCE RATIONALES:

The DePuy ACE A.I.M.® Titanium Tibial Nail is an intramedullary fixation of tibial fractures. The nail has a distal bend of 2º for the nails of 10mm, 11mm, 12mm diameters. The distal bend in the nails of 8mm and 9mm diameters is 5°. The DePuy ACE A.I.M.º Titanium Tibial Nail has diameters from 8.0mm to 13.0mm and lengths from 25.5cm. The proximal end of the 10mm, 11mm, 12mm , and 13mm nails is 13mm in diameter while the proximal end of the 8mm and 9mm nadiameter. The proximal end of the nail contains two 6mm cross locking screw holes which accept 5.5mm solid cortical bone screws and one 5mm long dynamization slot in the M-L plane. The distal end of the nail contains two 5.0mm holes in the M-L plane which accept 4.5mm solid cortical bone screws and one 5.0mm hole in the A-P plane positioned between the two transverse holes. The 8mm and 9mm nails are solid while the 10mm to 13mm nails are cannulated.

The DePuy ACE A.I.M. Titanium Tibial Nail is manufactured from Titanium 6A1-4V ELI (ASTM standard F-136).

The new DePuy ACE A.I.M.® Titanium Tibial Nail is the same basic design as the current DePuy ACE A.I.M. Titanium Tibial Nail, with the exceptions of adding a proximal dynamization slot in the M-L plane, which allows 5mm of length to dynamize across fracture site and that the two oblique proximal screw holes are moved more proximal to vield a longer working length for the nail. Also, there is an additional hole in the nail in the A-P plane. This is positioned between the current two distal transverse holes, allowing for oblique locking distally, which is more stable and allows the lagging of anterior fragments of the distal tibia. The additional holes and changes in placement are very similar to that of the Synthes Titanium Cannulated Tibial Nail and the Synthes Titanium Unreamed Tibial Nail.

Biomechanical testing was done using the Synthes product and the DePuy ACE Tibial Nail. On all tests, the DePuy Tibial Nail was either at least as strong or stronger than the Synthes Tibial Nail.

Based on this information, DePuy ACE believes that the modified DePuy ACE A.I.M. Titanium Tibial Nails are substantially equivalent to the DePuy ACE A.I.M." Titanium Tibial Nail, the Synthes Reamed Titanium Tibial Nail, and the Synthes Unreamed Titanium Tibial Nail.

ల్లో ప్ర

{1}------------------------------------------------

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" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

AUG 26 1997

K972183 Re: DePuy ACE A.I.M.® Titanium Tibial Nail Requlatory Class: II Product Code: HSB Dated: June 6, 1997 Received: June 10, 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 Requlations, 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 requlation 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 requlations.

{2}------------------------------------------------

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,

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

{3}------------------------------------------------

510(k) Number (if known)

DePuy ACE A.I.M.® Titanium Tibial Nail Device Name:

Indication For User:

The DePuy ACE A.I.M.® Titanium Tibial Nail is indicated for internal fixation of tibial fractures including transverse fractures, oblique fractures, spiral fractures, segmental fractures, comminuted fractures, fractures with bone loss, bone transport, open fractures, corrective osteotomies, pathologic fractures, pseudoarthrosis of the tibial shaft, nonunions, malunions, metaphyseal fractures and epiphyseal fractures.

Concurrence of CDRH, Office of Device Evaluation

OR Over-The-Counter Prescription Use (Per 21 CFR 801.109) (Division Sign-Off) (Division of General Restorative Devices ി 1972 510(k) Number .