ACE FISCHER EXTERNAL FIXATION SYSTEM

K083789 · DePuy Orthopaedics, Inc. · KTT · Mar 23, 2009 · Orthopedic

Device Facts

• Record ID: K083789
• Device Name: ACE FISCHER EXTERNAL FIXATION SYSTEM
• Applicant: DePuy Orthopaedics, Inc.
• Product Code: KTT · Orthopedic
• Decision Date: Mar 23, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The updated ACE-Fischer® External Fixation System is 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

Modular external fixation system; used for stabilization of long bone fractures and orthopedic reconstruction. System components include metallic bone fixation appliances; configured by surgeons in clinical settings to create frames tailored to specific fracture or deformity needs. Provides mechanical stability to bone segments to facilitate healing. Output is a rigid external frame; used by orthopedic surgeons to manage complex orthopedic cases. Benefits include versatile, customizable stabilization for diverse clinical applications.

Clinical Evidence

Bench testing only.

Technological Characteristics

Modular metallic bone fixation system; components include wires, pins, clamps, and rings. Metallic construction. No biocompatibility testing required. Manual assembly; no energy source or software.

Indications for Use

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

Predicate Devices

• ACE-Fischer External Fixation System (K801594)
• Fischer Wire/Pin Clamp (K860014)
• ACE-Fischer Percutaneous Half Pins (K875012)
• ACE Dupont Composite Rings (K955388)

Submission Summary (Full Text)

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# MAR 2 3 2009

# 510(k) Summary

| Submitted by: | DePuy Orthopaedics, Inc.<br>700 Orthopaedic Drive<br>Warsaw, IN 46581<br>Phone: [phone]<br>[phone]<br>Fax: | |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|
| Contact Person: | Suzana Otaño, Project Manager, Regulatory Affairs | |
| Date Prepared: | December 18, 2008 | |
| General<br>Provisions | The name of the device is: | |
| | Proprietary Name | Common or Usual Name |
| | | |
| | ACE-Fischer External Fixation | Single/multiple component metallic bone |
| | System | fixation appliances and accessories |
| | | |
| Name of Predicate<br>Devices | The device is substantially equivalent to the currently marketed DePuy ACE-<br>Fischer External Fixation system that consists of K801594: ACE-Fischer External<br>Fixation System, K860014: Fischer Wire/Pin Clamp, K875012: ACE-Fischer<br>Percutaneous Half Pins and K955388: ACE Dupont Composite Rings. | |
| Classification | Class II, 21 CFR 888.3030 and 888.3040 | |
| Performance<br>Standards | Performance standards have not been established by the FDA under section 514<br>of the Food, Drug and Cosmetic Act for these devices. | |
| Indications for<br>Use | The updated ACE-Fischer® External Fixation System is indicated for open and<br>closed long bone fracture fixation to include tensioned wire fixation of periarticular<br>fractures, arthrodesis, limb lengthening, osteotomy, reconstruction, non-unions,<br>pseudoarthrosis, correction of bony or soft tissue defects and deformities. | |
| Device<br>Description | The updated ACE-Fischer® External Fixation System is a highly versatile<br>frame that can be constructed for applications ranging from simple fractures to<br>complex reconstruction. This modular system can be configured for many<br>different applications. | |
| Biocompatibility | The updated ACE-Fischer® External Fixation System does not require<br>biocompatibility testing. | |
| Summary of<br>Substantial<br>Equivalence | The updated ACE-Fischer® External Fixation System is substantially<br>equivalent to the predicate devices. Equivalence was confirmed through bench<br>testing. | |

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## MAR 2 3 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DePuy Orthopaedics, Inc. % Ms. Suzana Otaño Project Manager, Regulatory Affairs 700 Orthopaedic Drive Warsaw, Indiana 46581

Re: K083789

Trade/Device Name: ACE-Fischer External Fixation System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and

accessories

Regulation Class: Class II Product Code: KTT, JDW Dated: February 18, 2009 Received: February 19, 2009

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.

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 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); good manufacturing practice requirements as set

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### Page 2 - Ms. Suzana Otaño

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. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.

Sincerely vours,

Samghim, m.D. for

Mark N. Melkerson Director Division of General. Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K083789 510(k) Number:

#### ACE-Fischer® External Fixation System Device Name:

### Indications For Use:

The updated ACE-Fischer® External Fixation System is 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) 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)

Sh. Arim, M.D.

storative.

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5100k)

DePuy ACE-Fischer External Fixation System Special 510(k)

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