REPROCESSED EXTERNAL FIXATION DEVICE

K081586 · Sterilmed, Inc. · KTT · Aug 18, 2008 · Orthopedic

Device Facts

• Record ID: K081586
• Device Name: REPROCESSED EXTERNAL FIXATION DEVICE
• Applicant: Sterilmed, Inc.
• Product Code: KTT · Orthopedic
• Decision Date: Aug 18, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This reprocessed external fixation device is indicated for use in the construction of an external fixation frame. When used with sterile bone pins and Kirschner wires, this device is used to provide stabilization of open and/or unstable fractures where soft tissue injury may preclude the use of other fracture treatments such as IM rods, casts, or other means of internal fixation

Device Story

Reprocessed external fixation device consisting of bridge elements (rods, articulating/telescoping components) and connection elements (clamps). Device functions as mechanical frame for bone stabilization; used in conjunction with sterile bone pins and Kirschner wires. Some components are MR safe. Device is reprocessed version of original manufacturer's system. Used by clinicians in surgical settings to stabilize fractures. Benefits include providing structural support for bone healing in patients where internal fixation is contraindicated due to soft tissue status.

Clinical Evidence

Bench testing only. Representative samples of reprocessed constructs underwent functional testing. Process validation performed for cleaning procedures. Manufacturing process includes visual and functional testing of all products.

Technological Characteristics

Metallic bone fixation components (rods, clamps, articulating/telescoping elements). Includes MR safe non-magnetic material options. Mechanical assembly for external frame construction. No software or electronic components.

Indications for Use

Indicated for patients with open and/or unstable fractures requiring external fixation frame stabilization where soft tissue injury precludes internal fixation, IM rods, or casts.

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

• Stryker Hoffman II® External Fixation System

Submission Summary (Full Text)

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### SUMMARY AND CERTIFICATION II.

#### 510(k) Summary A.

| Submitter: | SterilMed, Inc. |
|------------------------|------------------------------------------------------------------------------------------------------------|
| Contact Person: | Joshua Clarin<br>11400 73rd Avenue North<br>Maple Grove, MN 55369<br>Ph: 612-644-8402<br>Fax: [phone] |
| Date Prepared: | June 3, 2008 |
| Trade Name: | Reprocessed External Fixation device |
| Classification Name: | Single/multiple component metallic bone fixation appliances and<br>accessories. |
| Classification Number: | Class II, 21 CFR 888.3030 |

KTT Product Code:

| Predicate<br>Devices: | The reprocessed external fixation device is substantially equivalent to the Stryker Hoffman II®<br>External Fixation System. | |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Device<br>Description: | SterilMed's reprocessed external fixation devices consists of the standard bridge elements<br>(rods, articulating and telescoping components), and connection elements (clamps) contained in<br>the original manufacturer's system. Some of the components are MR safe and made of non-<br>magnetic materials. MR safe components are intended for use in the MR environment.<br><br>Note: Only the non-patient contact, external frame elements are the subject of this submission,<br>the anchorage pins and wire elements are not included in the scope of this submission | |
| Intended Use: | This reprocessed external fixation device is indicated for use in the construction of an external<br>fixation frame. When used with sterile bone pins and Kirschner wires, this device is used to<br>provide stabilization of open and/or unstable fractures where soft tissue injury may preclude the<br>use of other fracture treatments such as IM rods, casts, or other means of internal fixation | |
| Functional and<br>Safety Testing: | Representative samples of reprocessed external fixation constructs were tested to demonstrate<br>appropriate functional characteristics. Process validation testing was performed to validate the<br>cleaning procedure. In addition, the manufacturing process includes visual and validated<br>functional testing of all products produced. | |
| Conclusion: | The Reprocessed External Fixation Devices are substantially equivalent to the Stryker Hoffman®<br>II external fixation devices. | |
| | This conclusion is based upon the devices' similarities in functional design (principle of<br>operation), materials, indications for use and methods of construction. | |

# AUG 1 8 2008

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "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

## AUG 1 8 2008

SterilMed, Inc. % Mr. Joshua Clarin Sr. Regulatory Affairs Specialist 11400 73rd Avenue North Maple Grove, Minnesota 55369

Received: July 16, 2008

Re: K081586 Trade/Device Name: Reprocessed External Fixation Device Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: KTT Dated: July 15, 2008

Dear Mr. Clarin:

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 – Mr. Joshua Clarin

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic 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 cntitled, "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 yours,

Mark A. Milliman

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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## Indications for Use

·

510(k) Number (if known): KÖS 1586

Device Name: Reprocessed External Fixation Device

Indications for Use:

This reprocessed external fixation device is indicated for use in the construction of an external fixation frame. When used with sterile bone pins and Kirschner wires, this device is used to provide stabilization of open and/or unstable fractures where soft tissue injury may preclude the use of other fracture treatments such as IM rods, casts, or other means of internal fixation

Prescription Use X (Part 21 CFR 801 Subpart D)

: 1

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)


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

| 510(k) Number | K081586 |
|---------------|---------|
|---------------|---------|

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