ACE BIO WIN TIBIAL NAILING SYSTEM

K013430 · DePuy Orthopaedics, Inc. · HSB · Dec 17, 2001 · Orthopedic

Device Facts

• Record ID: K013430
• Device Name: ACE BIO WIN TIBIAL NAILING SYSTEM
• Applicant: DePuy Orthopaedics, Inc.
• Product Code: HSB · Orthopedic
• Decision Date: Dec 17, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ACE BioWin Tibial Nailing System is indicated in reamed and unreamed applications 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, metaphyseal fractures and epiphyseal fractures.

Device Story

System consists of intramedullary nail, cortical screws, end cap, and optional bioresorbable window. Used for internal fixation of tibial fractures. Surgeon inserts nail into tibial canal to stabilize bone segments. Provides mechanical support for fracture healing. Used in clinical/surgical settings by orthopedic surgeons.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Intramedullary nail, cortical screws, and end cap manufactured from Titanium (Ti-6Al-4V ELI). Optional bioresorbable window made from lactide/glycolide copolymer. Mechanical fixation device.

Indications for Use

Indicated for internal fixation of tibial fractures in patients requiring reamed or unreamed applications. Includes transverse, oblique, spiral, segmental, comminuted, pathologic, metaphyseal, and epiphyseal fractures, as well as bone loss, bone transport, open fractures, corrective osteotomies, pseudoarthrosis, nonunions, and malunions.

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 AIM Tibial Nail (K972183)
• Synthes AO Nail (K914453)
• Biomet LactoSorb 5.0mm washer (K001581)

Submission Summary (Full Text)

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

DEC 1 7 2001

K013430

Page 1 of 2

# 510(k) Summary

| Name of Sponsor: | DePuy Orthopaedics, Inc.<br>700 Orthopaedic Drive<br>Warsaw, Indiana 46581-0988<br>Est. Reg. No. 1818910 |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact: | Marcia J. Arentz<br>Senior Regulatory Associate<br>Phone: [phone]<br>FAX: [phone] |
| Trade Name: | ACE BioWin Tibial Nailing System |
| Common Name: | Bone fixation device |
| Classification: | Class II Device per 21 CFR 888.3020<br>Intramedullary fixation rod<br>Description: Rod, Fixation, Intramedullary and<br>Accessories, Metallic and Non-collapsible |
| Device Product Code: | Code: 87HSB<br>No performance standards have been established<br>under Section 514 of the Federal Food, Drug,<br>and Cosmetic Act for intramedullary nails or<br>bone fixation fasteners. |
| Substantially Equivalent Device: | ACE AIM Tibial Nail K972183<br>Synthes AO Nail K914453<br>Biomet LactoSorb ^® 5.0mm washer K001581 |
| Device Descriptions: | The BioWin Tibial Nailing System consists of an<br>intramedullary nail, cortical screws, end cap, and<br>an optional bioresorbable window. The nails,<br>screws and end cap are all manufactured from<br>Titanium (Ti-6Al-4V ELI) and the optional<br>bioresorbable window is made from a<br>lactide/glycolide copolymer. |

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

page 2 of 2
KOI 3430

## 510(k) Summary (continued)

Indications for use:

The BioWin Tibial Nailing System is indicated in reamed and unreamed applications for internal fixation of tibial fractures, including transverse fractures, spiral fractures, fractures, oblique comminuted fractures, segmental fractures, fractures with bone loss, bone transport, open corrective o osteotomies, pathologic fractures, fractures, pseudoarthrosis of the tibial shaft, nonunions, malunions, metaphyseal fractures and epiphyseal fractures.

Substantial equivalence:

The BioWin Tibial Nailing System has the same intended use and has the same general design features as the ACE AIM Tibial Nail and the Synthes AO nail and is therefore substantially equivalent to other legally marketed devices.

### 000006

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

Image /page/2/Picture/12 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 or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 7 2001

Ms. Marcia J. Arentz Senior Regulatory Associate DePuy Orthopedic, Inc. 700 Orthopedic Drive P.O. Box 988 Warsaw, Indiana 46581

Re: K013430

Trade/Device Name: Bio™Win Tibial Nailing System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary Fixation Rod Regulatory Class: Class II Product Code: HSB Dated: October 15, 2001 Received: October 16, 2001

Dear Ms. Arentz:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can may or dayse to and the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r rease of a rised a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

Page 2 - Ms. Marcia J. Arentz

This letter will allow you to begin marketing your device as described in your Section 510(k) This retor wification. The FDA finding of substantial equivalence of your device to a legally premarket notification. The a be 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 11 you dosile bpooms acres 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 Of 11 Sel-4659. Additionally, for questions on the promotion and advertising of Compinance at [phone] Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Tegulation entitiou, "Whiordialing of esponsibilities under the Act may be obtained from the Oinor general missimalion sturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

signature

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

510(k) Number (if known):

#### BioWin™ Tibial Nailing System Device Name:

#### Indications for Use:

The ACE BioWin Tibial Nailing System is indicated in reamed and unreamed applications 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, metaphyseal fractures and epiphyseal fractures.

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number_L_O13 430

Concurrence of CDRH, Office of Device Evaluation

સ > Prescription Use OR (Per 21 CFR/801.109)

Over-The-Counter Use No