TEMPFIX EXTERNAL FIXATION SYSTEM, MR SAFE

K043113 · DePuy Orthopaedics, Inc. · KTT · Jan 21, 2005 · Orthopedic

Device Facts

• Record ID: K043113
• Device Name: TEMPFIX EXTERNAL FIXATION SYSTEM, MR SAFE
• Applicant: DePuy Orthopaedics, Inc.
• Product Code: KTT · Orthopedic
• Decision Date: Jan 21, 2005
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The TempFix External Fixation System is indicated for: external fixation of open or closed long bone fractures and correction of bony or soft tissue defects or deformities. When used without adjunctive support, the TempFix External Fixation System is intended to be non-weight bearing. The TempFix External Fixation System is MR safe when specific guidelines are followed relative to the use of 1.5-Tesla MR systems, only.

Device Story

TempFix External Fixation System provides mechanical stabilization for long bone fractures and bony/soft tissue deformities. System consists of preassembled kits (knee frame, half pin ankle frame, 400 mm bar, transfixing pin ankle frame) allowing multiple degrees of freedom for positioning implantable threaded fixation pins. Components are radiolucent and lightweight. Device is used by clinicians in a clinical setting. Primary modification is the addition of MR safety claims for 1.5-Tesla MR environments, supported by material conformance testing.

Clinical Evidence

Bench testing only. No clinical data provided. Equivalence for MR safety is based on material conformance to established standards.

Technological Characteristics

System comprises metallic bone fixation components and accessories. Features radiolucent materials for improved imaging. Designed for assembly into knee or ankle frame configurations. MR safety validated for 1.5-Tesla systems.

Indications for Use

Indicated for external fixation of open or closed long bone fractures and correction of bony or soft tissue defects or deformities. Intended to be non-weight bearing when used without adjunctive support. MR safe for use with 1.5-Tesla MR systems only.

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

• TempFix™ External Fixation System (K021933)

Reference Devices

• Synthes Medium External Fixation System (K011034)
• EBI® DynaFix®Vision™ External Fixation System (K961433)

Submission Summary (Full Text)

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JAN 2 ] 2005

KO43113

## 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: | Claudia S. Swanson<br>Sr. Regulatory Specialist<br>Phone: [phone]<br>FAX: [phone] |
| Trade Name: | TempFix ^TM External Fixation System, MR Safe |
| Common Name: | External Fixation Devices |
| Classification: | Class II per 21 CFR 888.3030:<br>Multiple component metallic bone fixation<br>appliances and accessories |
| Device Product Codes: | 87 KTT |

#### Substantially Equivalent Devices:

K021933 TempFix™ External Fixation System (predicate device) Synthes Medium External Fixation System (for MR safety) K011034 EBI® DynaFix®Vision ™External Fixation System (for MR safety) K961433

#### Device Description:

The TempFix External Fixation System consists of components that can be assembled to provide multiple degrees of freedom for positioning implantable threaded fixation pins on either side of a fracture or deformity. The unique frame materials provide radiolucent viewing of the fracture and are lightweight for patient comfort. The components are preassembled in kits with three basic frame configurations: a knee frame, a half pin ankle frame, a 400 mm bar, and a transfixing pin ankle frame. Each kit is provided in sterile and non-sterile versions.

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#### Indications for use:

The TempFix External Fixation System is indicated for: external fixation of open or closed long bone fractures and correction of bony or soft tissue defects or deformities.

When used without adjunctive support, the TempFix External Fixation System is intended to be non-weight bearing.

DePuy is seeking the following additional claim:

The TempFix External Fixation System is MR safe when specific guidelines are followed relative to the use of 1.5-Tesla MR systems, only.

#### Substantial equivalence:

The TempFix™ External Fixation System was originally cleared via K021933.

DePuy is seeking additional claims for MR safety based on the conformance of the material to the standards included in Section I under E. Materials. Other comparable devices cleared for MR safety are the Synthes Medium External Fixation System (K011034), and the Biomet EBI® DynaFix®Vision™External Fixation System (K961433).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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JAN 2 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Claudia S. Swanson Sr. Regulatory Specialist DePuy Orthopaedics, Inc. 700 Orthopaedic Drive P.O. Box 988 Warsaw, Indiana 46581

Re: K043113 Trade/Device Name: TempFix External Fixation System, MR Safe Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT Dated: November 8, 2004 Received: November 10, 2004

Dear Ms. Swanson:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your became in ad the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use sualed in the environment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, de nees mar na re ocen require approval of a premarket approval application (PMA). and Cosmetic For (100) market the device, subject to the general controls provisions of the Act. The r ou may, mererere, mains of the Act include requirements for annual registration, listing of general controld provider in 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 rr your device is elassinod (vor at controls. Existing major regulations affecting your device can may or our 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 r hat FDA has made a determination that your device complies with other requirements of the Act that I Dr Has Intal 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 form in radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Claudia S. Swanson

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter witi anow you to oegin manoung of substantial equivalence of your device to a legally prematicate 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 If you ucate specific advice for your at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on your response Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

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

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

# Device Name: TempFix External Fixation System, MR Safe

### Indications for Use:

Existing indications cleared in K021933:

The TempFix External Fixation System is indicated for external fixation of open or closed long bone fractures and correction of bony or soft tissue defects or deformities.

When used without adjunctive support, the TempFix External Fixation System is intended to be nonweight bearing.

DePuy also sceks the following additional indications:

The TempFix External Fixation System is MR safe when specific safety guidelines are followed relative to the use of 1.5-Tesla MR systems, only.

Concurrence of CDRH, Office of Device Evaluation

Mark A. Milkeren

al, Restorative, and Neurological Devices

**510(k) Number** K043113

Prescription Use_ X (Per 21 CFR 801.109)

OR

Over-The-Counter Use