ACE-FISCHER(R), TEMPFIX(R), HOFFMAN CLASSIC(TM) EXTERNAL FIXATORS

K112218 · DePuy Orthopaedics, Inc. · KTT · Dec 15, 2011 · Orthopedic

Device Facts

• Record ID: K112218
• Device Name: ACE-FISCHER(R), TEMPFIX(R), HOFFMAN CLASSIC(TM) EXTERNAL FIXATORS
• Applicant: DePuy Orthopaedics, Inc.
• Product Code: KTT · Orthopedic
• Decision Date: Dec 15, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Indicated for open and closed long bone fracture fixation to include tensioned wire fixation of periarticular fractures, arthrodesis, limb lengthening, osteotomy, reconstruction, non-unions, pseudoarthrosis, correction of bony or soft tissue defects and deformities.

Device Story

ACE-Fischer External Fixation System is a metallic bone fixation device used for stabilizing long bone fractures and correcting deformities. The system consists of external fixators, including components for tensioned wire fixation. It is intended for use by orthopedic surgeons in clinical settings. The device is classified as MR Unsafe. The primary purpose of this submission was to document the performance and safety profile of the system within the MR environment. The device provides mechanical stabilization to facilitate bone healing and reconstruction. It does not involve electronic components, software, or automated analysis.

Clinical Evidence

Bench testing only. Evaluation was performed per ASTM F2052 to determine MR compatibility.

Technological Characteristics

Metallic bone fixation system (fixators, wires). Design and materials are unchanged from predicate. Classified as MR Unsafe. No software or electronic components.

Indications for Use

Indicated for patients requiring long bone fracture fixation, including periarticular fractures, arthrodesis, limb lengthening, osteotomy, reconstruction, non-unions, pseudoarthrosis, and correction of bony or soft tissue defects/deformities.

Regulatory Classification

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.

Submission Summary (Full Text)

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

K112218

| Submitted by: | DePuy Orthopaedics, Inc.<br>700 Orthopaedic Drive<br>Warsaw, IN 46581<br>Phone: [phone]<br>Fax: [phone] |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Suzana Otaño, Project Manager, Regulatory Affairs |
| Date Prepared: | August 1, 2011 |
| Proprietary Name: | ACE-Fischer® External Fixation System |
| Common Name: | External Fixation Systems |
| Classification Name: | Appliance, fixation, nail/blade/plate combination, multiple<br>component (21 CFR § 888.3030), KTT; Smooth or threaded metallic<br>bone fixation fastener (21 CFR § 888.3040), JDW |
| Predicate Devices: | The devices are substantially equivalent to their currently marketed<br>versions. |
| Device Description: | This submission covers DePuy Orthopaedics' external fixators and<br>their performance in the MR environment. The ACE-Fischer system<br>is classified as MR Unsafe. |
| Indications for Use: | Indicated for open and closed long bone fracture fixation to include<br>tensioned wire fixation of periarticular fractures, arthrodesis, limb<br>lengthening, osteotomy, reconstruction, non-unions,<br>pseudoarthrosis, correction of bony or soft tissue defects and<br>deformities. |
| Technological<br>Characteristics: | The technological characteristics of the devices that are the subject<br>of this submission remain unchanged from the predicate in design,<br>material and performance. |
| Summary of<br>Substantial<br>Equivalence: | The products that are the subject of this submission are<br>equivalent to the predicates and the design and<br>technological characteristics remain unchanged. Evaluation<br>was done based on ASTM F2052 to determine MR<br>compatibility. |

Page 1 of 1

DEC 1 5 2011

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

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and 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 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

DePuy Orthopaedics, Inc. % Ms. Suzana Otaño Senior Regulatory Affairs Specialist 700 Orthopaedics Drive Warsaw. Indiana 46581-0988

DEC 1 5 2011

Re: K112218

Trade/Device Name: ACE-Fischer External Fixator Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: KTT. JDW Dated: August 25, 2010 Received: August 26, 2010

Dear Ms. Otaño:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in 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 that FDA has made 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

## Page 2 - Ms. Suzana Otaño

device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803). please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vou

for

Mark N. Mel Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

## Section 4 – Indications for Use Statement

| 510(k) Number: | K112218 |
|---------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | ACE-Fischer External Fixation System |
| Indications For Use: | Indicated for open and closed long bone fracture fixation to include tensioned wire fixation of periarticular fractures, arthrodesis, limb lengthening, osteotomy, reconstruction, non-unions, pseudoarthrosis, correction of bony or soft tissue defects and deformities. |
| Prescription Use (Per 21 CFR 801 Subpart D) | X |
| | AND/OR Over-the-Counter (21 CFR 801 Subpart C) |

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF
NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

for MXU

(Division Sign-Off)

Division of Surgical, Orthopedic,
and Restorative Devices

: 1 - 1 - 1 - 1 - 1 -

510(k) Number K112218

Page 1 of 1

. . . .

·

. Electric de la secure se collection

..

ﻬﺎ، ﻓﺮﻧﺴﺎ ﺑﻌﺪ ﺍﻟﻤﻌﺎﺭﺿﺎ ﺑﻌﺪ ﺍﻟﻤﻌﺎﺭﺿﺎ ﺍﻟﻤﻌﺎﺭﺿﺎ ﺍﻟﻤﻌﺎﺭﺿﺎ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪ

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------