SYNTHES EXTERNAL FIXATION DEVICES, MR CONDITIONAL

K090658 · Synthes (Usa) · KTT · Mar 3, 2010 · Orthopedic

Device Facts

• Record ID: K090658
• Device Name: SYNTHES EXTERNAL FIXATION DEVICES, MR CONDITIONAL
• Applicant: Synthes (Usa)
• Product Code: KTT · Orthopedic
• Decision Date: Mar 3, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

Synthes External Fixation Devices, MR Conditional are intended for use in the construction of an external fixation frame for treatment of various fracture types that require external fixation. Synthes Medium External Fixation is intended for the construction of an external fixation frame for the treatment of pediatric and adult fractures. Synthes Distal Radius Fixator is intended for the fixation of the distal radius. Synthes Low-Profile Wrist Fixator is intended for stabilization of fractures of the distal radius. Synthes Elbow Hinge Fixator is intended for supplementary treatment of complex, unstable elbow injuries when early functional stress must be limited due to persistent ligament instability. The indications for guided joint bridging with external fixators are: - Delayed treatment of dislocated and stiff elbows . - Chronic, persistent joint instability . - Acute joint instability after complex ligament injuries . - . Unstable elbow fractures - Additional stabilization of post-operative unstable internal fixation

Device Story

Synthes External Fixation Devices, MR Conditional comprise previously cleared fixation components (Medium External Fixation, Distal Radius Fixator, Low-Profile Wrist Fixator, Elbow Hinge Fixator) modified to be MR Conditional. These devices are used by surgeons to construct external fixation frames for fracture stabilization. The system allows for guided joint bridging and is compatible with Synthes Large (11mm rod) and Medium (8mm rod) external fixator components. The device provides mechanical stabilization of bone fractures or joint injuries, allowing for early functional stress management. It is used in clinical settings for orthopedic trauma management.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Metallic bone fixation appliances. System includes rods (8mm and 11mm diameters) and fixation components. MR Conditional status. Mechanical fixation principle. No software or electronic components.

Indications for Use

Indicated for pediatric and adult patients requiring external fixation for fracture treatment, distal radius fixation, or stabilization of complex, unstable elbow injuries, including delayed treatment of dislocated/stiff elbows, chronic/acute joint instability, and post-operative stabilization.

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

• Synthes Medium External Fixation
• Synthes Distal Radius Fixator
• Synthes Low Profile Wrist Fixator
• Synthes Elbow Hinge Fixator
• Synthes Large External Fixation, MR Conditional

Submission Summary (Full Text)

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K090658

. · MAR - 3 2010

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Image /page/0/Picture/2 description: The image shows the word "SYNTHES" in a bold, sans-serif font. To the left of the word is a circular logo with a stylized image inside. A horizontal line is present below the word. A registered trademark symbol is present to the right of the word.

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## 3.0 510(k) Summary

Page _________________________________________________________________________________________________________________________________________________________________________

| Sponsor: | Synthes (USA)<br>1301 Goshen Parkway<br>West Chester, PA 19380<br>[phone] |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Jill R. Yelton<br>Synthes (USA)<br>1301 Goshen Parkway<br>West Chester, PA 19380<br>Phone: [phone]<br>Fax: [phone] |
| Device Name: | Synthes External Fixation Devices, MR Conditional |
| Classification: | 21 CFR Part 888.3030; Single/multiple component metallic bone fixation<br>appliances and accessories. |
| Predicate Devices: | Synthes Medium External Fixation<br>Synthes Distal Radius Fixator<br>Synthes Low Profile Wrist Fixator<br>Synthes Elbow Hinge Fixator<br>Synthes Large External Fixation, MR Conditional |
| Device<br>Description: | The Synthes External Fixation Devices, MR Conditional consists of<br>previously cleared Medium External Fixation, Distal Radius Fixator, Low-<br>profile Wrist Fixator and Elbow Hinge Fixator devices that are used to<br>construct an external fixation frame. |
| Intended Use: | Synthes External Fixation Devices, MR Conditional are intended for use<br>in the construction of an external fixation frame for treatment of various<br>fracture types that require external fixation. |

Information presented supports substantial equivalence.

Substantial Equivalence

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Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

Synthes (USA) c/o Ms. Jill R. Yelton Manager, Regulatory Affairs 1301 Goshen Parkway West Chester, Pennsylvania 19380

MAR - 3 2010

Re: K090658

Trade/Device Name: Synthes External Fixation Devices, MR Conditional Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliance Regulatory Class: Class II Product Code: KTT Dated: December 21, 2009 Received: December 22, 2009

Dear Ms. Yelton:

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. Jill R. Yelton

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 rr you dosite specific and 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Sincerely yours,

Mark A. Milliken

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

Enclosure

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Indications for Use

510(k) Number (if known):

2.0

KO90658

## Synthes External Fixation Devices, MR Conditional Device Name:

Indications for Use: Synthes External Fixation Devices, MR Conditional are intended for use in the construction of an external fixation frame for treatment of various fracture types that require external fixation.

Synthes Medium External Fixation is intended for the construction of an external fixation frame for the treatment of pediatric and adult fractures.

Synthes Distal Radius Fixator is intended for the fixation of the distal radius.

Synthes Low-Profile Wrist Fixator is intended for stabilization of fractures of the distal radius.

Synthes Elbow Hinge Fixator is intended for supplementary treatment of complex, unstable elbow injuries when early functional stress must be limited due to persistent ligament instability. The indications for guided joint bridging with external fixators are:

- Delayed treatment of dislocated and stiff elbows .
- Chronic, persistent joint instability .
- Acute joint instability after complex ligament injuries .
- . Unstable elbow fractures
- Additional stabilization of post-operative unstable internal fixation

The Elbow Hinge Fixator is compatible with the components of the Synthes Large External Fixator System for adults (rod diameter: Øl 1 mm), and with components of the Synthes Medium External Fixator System (rod diameter: Ø8mm) for children and small stature adults.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use<br>(Per 21 CFR 801.109) | X |
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AND/OR

| Over-The-Counter Use<br>(21 CFR 807 Subpart C) | |
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(Division Sign-Off)

Division of Surgical, Orthopedic,

and Restorative Devices

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| 510(k) Number | K090658 |
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